PRESS RELEASE by APEPTICO
Vienna, Austria, February 18th 2015
APEPTICO, a privately-held biotechnology company developing synthetic protein structures, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed the phase III clinical development strategy for APEPTICO’s AP301-peptide in the orphan condition Acute Respiratory Distress Syndrome.
APEPTICO announced today that it has received scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) for the forthcoming phase III clinical trial of the AP301-peptide in the life-threatening and orphan condition Acute Respiratory Distress Syndrome (ARDS). According to the written advice, APEPTICO is encouraged to initiate a two-part phase III double blind clinical trial. The CHMP also confirmed that no further non-clinical studies are needed to continue the clinical development program.
The CHMP suggests that in the first part of the phase III clinical study aspects of dose finding should be incorporated. The formal proof of efficacy should be demonstrated in the second part of the phase III clinical trial. In addition, the CHMP would agree that a positive first part phase III study could be a basis to apply for conditional marketing approval.
In a setting with co-primary endpoints CHMP could accept a benefit demonstrated with “ventilator-free days” (VFD) as long as convincing evidence is also provided that “all-cause-mortality at day 28” is not adversely affected by the AP301-peptide.
Bernhard Fischer, CEO of APEPTICO commented ”We are very pleased that the EMA has given us constructive scientific advice and provided protocol assistance to the forthcoming clinical development of AP301-peptide.” “A potential conditional marketing approval of AP301-peptide following successful completion of a first-part phase III clinical trial will significantly speed up both the completion of the entire phase III trial and the final approval process of AP301-peptide in Europe” he added.
About APEPTICO GmbH
APEPTICO is a privately-held biotechnology company based in Austria, developing peptide-based products targeting chronic and life-threatening diseases. The peptide molecules correspond to validated, pharmacodynamic active structures and domains of well-known proteins and biopharmaceuticals. By concentrating on synthetically produced protein structures APEPTICO avoids general risks associated with gene- and cell-technologies. APEPTICO makes use of its technology platforms PEPBASE(TM) and PEPSCREEN(TM) to significantly reduce cost and to shorten time to market.
About the APEPTICO’s synthetic protein structures
APEPTICO’s molecules are synthetically manufactured structural equivalents to domains of the human Tumour Necrosis Factor-α. The protein structures are water-soluble and can be administered into the lung by inhalation of liquid aerosol droplets of diameter 4 μm or less. Most recently, APEPTICO has successfully completed two phase II clinical trials with orally inhaled peptides for treatment of pulmonary permeability oedema and treatment of primary graft dysfunction following lung transplantation. APEPTICO’s synthetic molecules have been granted orphan drug status various life-threatening condition by the European Medicines Agency (EMA) and by the Food and Drug Agency (FDA).
About the AP301-peptide / TIP-peptide
The AP301-peptide (synonym to TNF-derived TIP-peptide) is a synthetically manufactured molecule whose structure bases on the lectin-like domain of the human Tumour Necrosis Factor α. The AP301 peptide is water-soluble and can be administered into the lung by oral inhalation. Formulated AP301 is easily nebulised and the resulting aerosol is composed of peptide/water droplets of diameter 4 μm or less. APEPTICO’s most recent clinical phase II proof-of-concept study (ClinicalTrials.gov ID NCT01627613) demonstrated that orally inhaled AP301-peptide activates alveolar liquid clearance in mechanically ventilated patients with pulmonary permeability oedema and ARDS.
Comprehensive research and development studies conducted by the APEPTICO research consortium demonstrated that AP301-peptides are effective therapeutic molecules in various forms of pulmonary oedema, such as pulmonary permeability and hydrostatic oedema, high altitude pulmonary oedema, pulmonary oedema associated with acute lung injury / acute respiratory distress syndrome, pulmonary oedema resulting from pneumonia and sepsis, and primary graft dysfunction following lung transplantation.
Currently, no specific drug treatment exists for life-threatening conditions such as pulmonary permeability oedema and ARDS, primary graft dysfunction following lung transplantation and high altitude pulmonary oedema.
APEPTICO’s AP301 has received orphan drug designation status for various life-threatening conditions by the European Commission and European Medicines Agency (EMA) and by the Food and Drug Agency (FDA).
Contact
Univ.-Doz. Dr. Bernhard Fischer, Chief Executive Officer
APEPTICO Forschung und Entwicklung GmbH
Mariahilferstraße 136, Top 1.1.5
1150 Vienna, Austria
T: +43-664-1432919
F: +43-1-25330337795
E-mail: b.fischer@apeptico.com
URL: www.apeptico.com
PRESS RELEASE, April 9rd, 2014
APEPTICO announces top-line results in phase IIa clinical study of AP301 in treatment of pulmonary permeability oedema in mechanically ventilated patients
Vienna, Austria, April 9th, 2014: APEPTICO, a privately held biotechnology company developing peptide drugs, today announced that the phase IIa clinical study of AP301 delivered top-line results in the treatment of pulmonary permeability oedema in mechanically ventilated patients suffering from Acute Respiratory Distress Syndrome..
Pulmonary oedema occurs when fluid leaks from the pulmonary capillary network into the lung interstitium and alveoli. There are many possible causes of lung oedema, such as sepsis, trauma, pneumonia, aspiration, cardiac failure, and other. Massive pulmonary permeability oedema is a major characteristic of Acute Respiratory Distress Syndrome (ARDS) too, a life-threatening condition having a mortality rate of around 35-45%, despite modern day care. Currently, there is no effective pharmacotherapy available for treatment of pulmonary permeability oedema and patients having ARDS.
AP301 is a small peptide designed to activate pulmonary oedema clearance in a variety of patients, including mechanically ventilated patients. AP301 opens up the pulmonary epithelial sodium ion channel (ENaC), blunts protein kinase C-α activation and MLC phosphorylation, and reduces reactive oxygen species generation in lung tissue. All this leads to lung tissue repair and pulmonary oedema clearance.
The proof-of-concept phase IIa clinical study was conducted at the Division of General Anaesthesia and Intensive Care Medicine of the Medical University of Vienna. It was an interventional, randomized, double blind, placebo-controlled, parallel-group study. Patients were randomized in a 1:1 ratio. The primary objective of this study was to assess the treatment-associated changes of extra-vascular lung water (EVLW) upon oral inhalation of AP301 in comparison to placebo. Patients were evaluated every 12 hours for 7 days.
Results from this study showed that oral inhalation of AP301 led to an earlier onset and more pronounced activation of pulmonary oedema clearance compared to placebo. Subgroup analysis revealed that oral inhalation of AP301 was statistically significant and more effective in pulmonary oedema clearance in patients with elevated Sequential Organ Failure Assessment (SOFA) score compared to placebo. AP301 was equally effective in patients with direct and indirect lung injury and patients with initial very low P/F-ratio. In addition to oedema clearance, upon AP301 inhalation, critical patient’s parameters, such as oxygenation index and Murray Lung Injury score, improved.
Dr. Bernhard Fischer, CEO of APEPTICO, stated: “We are very proud to have achieved this significant clinical goal. I am convinced that AP301 will have the potential to play a key role in the management of various forms of pulmonary oedema. This major success would not have happened without the steady support by Professor Rudolf Lucas from the Medical College of Georgia, Professor Rosa Lemmens-Gruber from the Institute of Pharmacology and Toxicology of the University of Vienna, and the clinical teams of Professor Roman Ullrich and Professor Klaus Markstaller from the Division of General Anaesthesia and Intensive Care Medicine of the Medical University Vienna”. “Our excellent scientific results will establish partnering process with interested global and specialised pharmaceutical and biotech companies,” Dr. Fischer added.
PRESS RELEASE, December 3rd, 2013
APEPTICO publishes significant scientific results of its development compound AP301
Vienna, Austria, December 3rd, 2013: APEPTICO, a privately-held biotechnology company developing peptide drugs, today announced that significant scientific results of its development compound AP301 have been published in Molecular Pharmacology and The Journal of Clinical Pharmacology, summarising the mode of action of AP301 in activating the amiloride-sensitive epithelial sodium ion channel (ENaC) and presenting the results of APEPTICO’s first-in-man clinical study of orally inhaled AP301.
APEPTICO develops the AP301 peptide compound for the activation of pulmonary oedema clearance in intensive care patients with life-threatening oedematous respiratory failure and acute respiratory distress syndrome.
The December volume of Molecular Pharmacology publishes the original research article “Mechanism of action of novel lung edema therapeutic AP301 by activation of the epithelial sodium channel” (http://molpharm.aspetjournals.org/content/84/6/899.abstract) resulting from APEPTICO’s scientific collaboration with the Department of Pharmacology and Toxicology of the University of Vienna. The mode of action of AP301 peptide in activating the amiloride-sensitive epithelial sodium ion channel (ENaC) was studied in A549 lung epithelial cells as well as in human embryonic kidney cells and chinese hamster ovary cells heterologously expressing human ENaC subunits α, β, γ, and δ. The data suggest that AP301 specifically targets endogenously and heterologously expressed ENaC, activates proteolytically processed ENaC in a reversible manner, requires the pore-forming α- or δ-subunit co-expressed with βγ-subunits for maximal activity, and requires glycosylated extracellular domains of ENaC to enable binding of AP301 to the ion channel.
In collaboration with the Department of Clinical Pharmacology of the Medical University of Vienna, safety and tolerability of orally inhaled AP301 peptide was assessed in a FIM (first-in-man) clinical study at the Vienna General Hospital. The results of this study are summarised as “A FIM study to assess safety and exposure of inhaled single-doses of AP301–A specific ENaC channel activator for the treatment of acute lung injury” in the December volume of The Journal of Clinical Pharmacology (http://onlinelibrary.wiley.com/doi/10.1002/jcph.203/abstract). In the phase I clinical study 48 subjects received treatment, and completed the study as per protocol. No serious or local adverse events were noted. None of the assessments indicated notable dose or time-related alterations of safety outcomes. Inhaled AP301 single doses up to 120 mg were safe and well tolerated by study subjects. Distribution of inhaled AP301 was largely confined to the lung, as indicated by very low AP301 systemic exposure levels.
Dr. Bernhard Fischer, CEO of APEPTICO, commented: “2013 was another very productive year in the research & development programme of APEPTICO, illustrating that the Company’s strategy of investigating the mode of action and clinical use of its lead compound AP301 through a network of research collaborations, is paying off.” “AP301 has successfully completed a phase I clinical study and is currently undergoing two different phase II clinical trials in patients with life-threatening lung oedema and primary graft dysfunction following lung transplantation, respectively. We are looking forward reviewing the clinical data from both studies in just a few weeks from today” Dr. Fischer added.
About APEPTICO GmbH (www.apeptico.com)
APEPTICO is a privately-held biotechnology company based in Austria, developing peptide-based products targeting chronic and life-threatening diseases. The peptide molecules correspond to validated, pharmacodynamic active structures and domains of well-known proteins and biopharmaceuticals. By concentrating on synthetically produced protein structures APEPTICO avoids general risks associated with gene- and cell-technologies. APEPTICO makes use of its technology platforms PEPBASE(TM) and PEPSCREEN(TM) to significantly reduce cost and to shorten time to market.
About the AP301 peptide family
AP301 and derived peptides are synthetic molecules whose structures are based on the lectin-like domain of human Tumour Necrosis Factor alpha. AP301 peptides are water soluble and can be administered into the lung by oral inhalation. Formulated AP301 is easily nebulised and the resulting aerosol is composed of peptide/water droplets of diameter 4 μm or less. AP301 and derived peptides are designed for activation of the pulmonary epithelial sodium channel (ENaC). Activation of ENaC by AP301 results an accelerated lung oedema clearance in the airspace. Comprehensive research and development conducted by APEPTICO has demonstrated that AP301 peptides are effective in animal models of various forms of pulmonary oedema, including high altitude pulmonary oedema, acute lung injury / acute respiratory distress syndrome, pneumonia, influenza virus lung infection, and lung transplantation. Currently, AP301 is subject to two Phase IIa clinical studies for the treatment of patients suffering from life-threatening oedematous respiratory failure and primary graft dysfunction following lung transplantation, respectively.
About oedematous respiratory failure
Respiratory failure occurs when the respiratory system fails in oxygenation and/or carbon dioxide elimination. Oedematous Respiratory Failure is caused by a massive and life-threatening pulmonary oedema. Pulmonary oedema occurs when fluid leaks from the pulmonary capillary network into the lung interstitium and alveoli. There are many possible causes of lung oedema, such as inhaling high concentrations of smoke, toxins, or oxygen; severe burns; blood infections; lung infections; or trauma to other parts of the body. Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) are catastrophic forms of lung oedema. Lungs contain alveoli, which are tiny air sacs where the oxygen is passed into the blood. During lung oedema, blood and fluid begin to leak into the alveoli. When this happens, oxygen cannot enter the alveoli, which means oxygen no longer passes into the blood. Because the lungs are inflamed and filled with fluid, the patient finds it increasingly difficult to breathe. The mortality rate of patients with pulmonary oedema in ALI/ARDS is 30% to 60% within two to four weeks. Currently, no specific drug treatment exists for patients suffering from hyper-permeability-caused lung oedema.
About Primary Graft Dysfunction
Primary Graft Dysfunction (PGD) (Ischemia Reperfusion Injury, IRI) is characterized by poor oxygenation as the main criterion for the condition and is also characterized by low pulmonary compliance, interstitial/alveolar oedema, pulmonary infiltrates on chest radiographs, increased pulmonary vascular resistance, intrapulmonary shunt and acute alveolar injury, as revealed by diffuse alveolar damage (DAD) on pathology. PGD occurs in approximately 20% of lung transplant recipients and patients face prolonged ventilation, prolonged stays in the ICU and the hospital overall, increased medical costs, and increased risk of morbidity and mortality. Currently, no specific drug treatment exists for patients suffering primary graft dysfunction following lung transplantation.
Contact
Univ.-Doz. Dr. Bernhard Fischer, Chief Executive Officer
APEPTICO Forschung und Entwicklung GmbH
Mariahilferstraße 136, Top 1.1.5
1150 Vienna, Austria
T: +43-664-1432919
F: +43-1-25330337795
E-mail: b.fischer@apeptico.com
URL: www.apeptico.com
PRESS RELEASE, July 8, 2013
APEPTICO accelerates its clinical development program with a research grant from the Austrian Research Promotion Agency (FFG)
Vienna, Austria, July 8, 2013 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE™ discovery technology, today announced that it has received a research grant worth more than EUR 500,000 from the Austrian Research Promotion Agency (FFG) to accelerate the clinical assessment of the AP301 peptide in patients following lung transplantation.
AP301 is synthetic peptide which has been shown in animal studies in rats and pigs following application by inhalation of the nebulised compound, to prevent and treat ischemia reperfusion injury, to significantly improve gas exchange in pre-damaged donor lungs and to activate lung oedema reabsorption. Until today, no medicinal product has been specifically authorized by medicines agencies for prevention and treatment of primary graft dysfunction / ischemia reperfusion injury in the lung following lung transplantation.
The research grant to APEPTICO results from the FFG recently established research promotion scheme “KLIPHA”. “KLIPHA” specifically aims to enable research-driven companies in Austria to perform phase I and phase II clinical studies with their new molecules. APEPTICO will use the FFG grant for its phase IIa “Pilot study to investigate the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) in mechanically ventilated patients after primary lung transplantation” which started last month at the Medical University Vienna / Vienna General Hospital, Austria.
"We are very pleased that the Austrian Research Promotion Agency (FFG) supports us in our efforts to access the AP301 peptide in this orphan clinical indication” said Bernhard Fischer, CEO of APEPTICO. “Prevention and treatment of primary graft dysfunction represents an unmet medical need as no specific therapy or medicinal product has been approved so far for this life-threatening condition. Having successfully completed our Phase I clinical trial in 2011, this is our second Phase II clinical study in pulmonary patients. We initiated a Phase II clinical study in patients suffering from oedematous respiratory failure in summer 2012 and the new clinical study in lung transplantation patients broadens the therapeutic application of our lead compound AP301.”
PRESS RELEASE, May 28, 2013
ugichem receives €2.25 million funding for antisense drug platform
Innsbruck, May 28, 2013 --- ugichem GmbH, developer of a novel antisense drug platform, has raised €2.25 million from public and private investors to advance preclinical Ugimer® drug development for immune-mediated inflammatory diseases (IMID). ugichem was awarded a grant of €850,000 by Austria’s Research Promotion Agency FFG and received an equity financing of €1.4 million from existing investors.
Based on its proprietary Ugimer platform ugichem aims to develop a pipeline of antisense drugs addressing unmet medical needs in indications involving inflammatory processes with a current focus on rheumatoid arthritis.
With a new in vivo efficacy and safety profile the Ugimer antisense drug platform enables the functional modification of disease-relevant, previously undruggable targets in tissues and cells of the immune system not amenable to standard antisense approaches and RNAi. Ugimers penetrate immune cells, such as T cells, without the need for additional delivery tools and do not stimulate the immune system resulting in reduced side effects and an improved safety profile. Recent preclinical data using Ugimers demonstrated a highly efficacious modulation of target mRNAs and, consequentially, a significant reduction of inflammatory cytokines after endotoxemia in vivo in various key tissues for inflammatory disease including the spleen and thymus.
Dr Holger Bock, CEO of ugichem, said: “During the past two years we have generated significant evidence to support our unique antisense platform. Ugimers enable the utilization of the powerful antisense mechanism to modulate previously undruggable targets in inflammation. The additional funding will be used to further build on the therapeutic value of Ugimers and will allow us to identify lead candidates in acute and chronic inflammation.”
PRESS RELEASE, April 17, 2013
APEPTICO initiates phase II clinical trial with AP301 in patients with primary graft dysfunction following lung transplantation
Vienna, Austria, April 17, 2013 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE™ discovery technology, today announced that the Ethics Committee of the Medical University of Vienna has approved the company’s application to perform a phase IIa clinical study in male and female patients following lung transplantation to investigate the clinical effect of repetitive orally inhaled doses of AP301 on primary graft dysfunction.
AP301 is synthetic peptide which has been shown in animal studies in rats and pigs following application by inhalation of the nebulised compound, to prevent and treat ischemia reperfusion injury, to significantly improve gas exchange in pre-damaged donor lungs and to activate lung oedema reabsorption. Until today, no medicinal product has been specifically authorized by medicines agencies for prevention and treatment of primary graft dysfunction / ischemia reperfusion injury in the lung following lung transplantation.
The interventional, randomized, placebo-controlled, parallel-group study entitled “Pilot study to investigate the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) in mechanically ventilated patients after primary lung transplantation” will be conducted at the Vienna General Hospital and the Medical University of Vienna, Austria. Immediately after lung transplantation, patients will be screened for early signs of primary graft dysfunction. Patients who are included into the study will receive doses of AP301 or matching placebo converted into an aerosol by state-of-the-art nebuliser technology over a period up to 7 days.
"We are very pleased that the Ethics Committee has approved our study” said Bernhard Fischer, CEO of APEPTICO. “Prevention and treatment of primary graft dysfunction represents an unmet medical need as no specific therapy or medicinal product has been approved so far for this life-threatening condition. Having successfully completed our Phase I clinical trial in 2011, this is our second Phase II clinical study in pulmonary patients. We initiated a Phase II clinical study in patients suffering from oedematous respiratory failure (ALI/ARDS) in summer 2012 and the new clinical study in lung transplantation patients broadens the therapeutic application of our lead compound AP301.”
Press release, January 18, 2013
APEPTICO granted Orphan Drug Designation by EMA and FDA
for development compound AP301 for treatment of High Altitude Pulmonary Oedema
18th January, 2013, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced that its development compound AP301 has been granted orphan-drug designation by the Committee for Orphan Medicinal Products (European Medicines Agency, EC) and by the Office of Orphan Product Development (Food and Drug Administration, USA) for the clinical indication “treatment of High Altitude Pulmonary Oedema”.
High Altitude Pulmonary Oedema (HAPE) is a life-threatening complication of rapid ascent to altitudes higher than 3,000 meters. HAPE represents a non-cardiogenic pulmonary oedema that usually occurs within the first 2–5 days after arrival at high altitude. HAPE is a life-threatening condition with a mortality rate of approx. 25%.
Until today, no drug has been registered, either in Europe or the USA, for prevention and/or treatment of HAPE. HAPE is a life-threatening condition that may affect individuals of any geographic origin when travelling from low to high altitude locations. APEPTICO’s synthetic peptide is the first ever compound receiving orphan drug designation for this indication.
Dr. Bernhard Fischer, CEO of APEPTICO commented: “I am pleased that both the European Medicines Agency and the Food and Drug Administration have approved our application for orphan drug designation for AP301 for treatment of High Altitude Pulmonary Oedema. Until today there exists no approved treatment for this life-threatening condition in which the airspace in the lung becomes flooded with body fluids preventing normal gas exchange due reduced air pressure and decreased oxygen supply at high altitude level. Taking into account the steadily increasing mobility of people worldwide, HAPE may affect increasing numbers of tourists and workers in high altitude regions, such as the Alps and Pyrenees in Europe, the Himalayas in Asia, and mountains in Alaska in the USA or the Andes in South America.” Dr. Fischer added, “HAPE was first described in great detail in a series of reports from an expedition to the Mont Blanc massive in 1891, having been published in the Swiss “Neue Zürcher Zeitung” in August and September 1891. During this Mont Blanc expedition, at least four members of the team suffered from HAPE, one of whom,the expedition’s medical doctor, Dr. Jacotte, unfortunately died at an altitude of about 4,000 meters. With our innovation we hope to make an important contribution to the field of environmental medicine by improving the patient’s condition and avoiding an unfortunate outcome, if affected by HAPE.”
Press release, June 29, 2012
APEPTICO Initiates Phase II Trial with AP301 in Patients with Pulmonary Oedema
Vienna, Austria, June 29, 2012 - APEPTICO, a privately-held biotechnology company developing peptide drugs based on its PEPBASE™ discovery technology, today announced the initiation of a proof of concept study in male and female intensive care patients to investigate the clinical effect of repetitive orally inhaled doses of AP301 on alveolar liquid clearance.
AP301 is the first compound against respiratory failure caused by pulmonary oedema that activates lung oedema reabsorption and thus differs from the currently used anti-inflammatory treatment that often fails in patients with acute lung injury. The synthetic peptide AP301 activates alveolar liquid clearance (ALC) and prevents hyper-permeability in both endothelial and epithelial lung tissue. AP301 also prevents ischaemia reperfusion injury in the lower respiratory tract following lung transplantation.
The interventional, randomized, double-blind, placebo-controlled, parallel-group “proof of concept” study is conducted in Austria. Intensive care patients will receive doses of AP301 or matching placebo converted into an aerosol by state-of-the-art nebuliser technology over a period up to 7 days.
"We are very pleased that both the Ethics Committee and the Competent Authority approved our study only a few weeks after completion of the phase I clinical trial” said Bernhard Fischer, CEO of APEPTICO. “Treatment of oedematous respiratory failure represents an unmet medical need as no specific therapy or medicinal product has been approved so far for the prevention and treatment pulmonary oedema caused by hyper-permeability.”
Press release, May 16, 2012
APEPTICO completes a EUR 3.4 million financing round
16th May, 2012, Vienna, Austria: APEPTICO Forschung und Entwicklung GmbH, a biotechnology company developing novel peptide-based drugs, today announced completion of a EUR 3.4 million financing round. This equity financing combined existing and new private and institutional investors, as well as a research grant from the Austrian Research Promotion Agency (FFG).
A financing contribution of EUR 2 million is shared by institutional investors “The BioScience Venture Group”, “V+ GmbH & Co Fonds 2 KG” and “V+ GmbH & Co Fonds 3 KG”, and by private investors from Germany, Switzerland and the USA. Based on a previous and substantial capital increase in the year 2011, APEPTICO had already secured a research grant of EUR 1.4 million from the Austrian Research Promotion Agency (FFG) by the end of 2011.
Dr. Bernhard Fischer, CEO of APEPTICO commented: “We are delighted to have secured our third equity financing with an international syndicate of venture capital, private investors and the FFG. This round C financing enables us to continue the clinical development of our lead peptide AP301. AP301 will be assessed in a “proof of concept” study in intensive care patients to investigate the clinical effect of repetitive orally inhaled doses of AP301 on alveolar liquid clearance in acute lung injury.
About APEPTICO GmbH
APEPTICO Forschung und Entwicklung GmbH is a privately-held biotechnology company based in Austria, developing peptide-based products targeting chronic and life-threatening diseases. The peptide molecules correspond to validated, pharmacodynamic active structures and domains of well-known proteins and biopharmaceuticals. By concentrating on synthetically produced protein structures APEPTICO avoids any risk of transmitting microbial and viral infections. Development cost and time to market are significantly reduced if compared to the recombinant development process of biomolecules.
About AP301
AP301 is a synthetic molecule whose structure is based on the lectin-like domain of human Tumour Necrosis Factor alpha. AP301 is water soluble and can be administered into the lung by oral inhalation. Formulated AP301 is easily nebulised and the resulting aerosol is composed of peptide/water droplets of diameter 4 μm or less. AP301 has been designed for activation of the pulmonary epithelial sodium channel (ENaC). Activation of ENaC by AP301 peptides results an accelerated oedema clearance in the airspace in animal models of the pulmonary permeability oedema, pneumonia, influenza virus lung infection, Acute Lung Injury and lung transplantation. AP301 has received Orphan Drug Designation by the EMA and by the FDA for various indications. In 2011, AP301 has shown to be safe and well-tolerated by volunteer study subjects.
Press release, August 19, 2011
Innsbruck, August 19, 2011 --- ugichem today announced the extension of its management team. With the closing of the new financing round Dr. Ulrich Bodner and Dr. Jürgen Soutschek have joined ugichem. Both are experienced biotech professionals with a focus on gene silencing business..
[more]
Press release, August 06, 2011
Innsbruck-based ugichem today announced the closing of a € 2 million follow-up financing. The present lead investor "The BioScience Venture Group" and the new investor V+ GmbH & Co Fonds 3 KG participated in this € 1.4 million equity financing round as well as notable Swiss private investors. Additionally ugichem received a € 0.6 million research grant from the Austrian Research Promotion Agency (FFG).
[more]
Press release, April 07, 2011
APEPTICO Initiates Phase I Trial with AP301 in Pulmonary Oedema
[more]
Press release, February 03, 2011
Nano4Imaging new innovative start-up at Chemelot
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Press release, February 01, 2011
MagnaMedics erhält Venture Capital-Finanzierung
Ausgründung des Geschäftsbereichs „Imaging“ ermöglicht
Weiterentwicklung nach Plan
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Press release, August 05, 2010
APEPTICO completes €3 million financing round
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Press release, September 08, 2009
APEPTICO presents its lead product AP301
at the Annual Congress of the European Respiratory Society in Vienna, Austria
[more]
Press release, August 11, 2009
Adriacell Closing of A Round Financing
11th August 2009, Trieste – Italy: Adriacell, a preclinical, oncology-focused biotech company
announced the completion of A round financing.
[more]
Press release, July 20, 2009
APEPTICO granted Orphan Medicinal Product Designation
by EMEA for lead product AP301
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Press release, June 9, 2009
APEPTICO GmbH erhält Preis anlässlich der Verleihung des
“Venture Capital & Private Equity Award Österreichs“
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Press release, May 29, 2009
APEPTICO GmbH closes seed financing round
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March 23, 2009
ugichem to enter into research collaboration with Santhera Pharmaceuticals to evaluate and apply ugichem’s
oligonucleotide platform technology in the field of rare neuromuscular diseases
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Press release, October 27, 2008
Starke Wachstumsaussichten für den Nanomedizin-Spezialisten
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