Top-line data from a double-blind, Austrian Phase IIa trial in mechanically-ventilated ARDS patients showed that orally inhaled AP301 led to earlier onset and "more pronounced activation" of pulmonary edema clearance vs. placebo. Additionally, a subgroup...

Apeptico Forschung und Entwicklung GmbH (Vienna, Austria) said orally inhaled AP301 led to earlier onset and "more pronounced activation" of pulmonary edema clearance vs. placebo in a Phase IIa trial to treat pulmonary permeability edema...

Next month, Apeptico will begin a placebo-controlled, Austrian Phase IIa trial to evaluate AP301 delivered via aerosol by nebulizer technology for up to 7 days in mechanically ventilated patients with primary graft dysfunction following lung...

Apeptico said FDA and EMA granted Orphan Drug designation to AP301 to treat high altitude pulmonary edema. The product is in Phase IIa testing to treat edematous respiratory failure. AP301 also has Orphan Drug designation...

Apeptico began a double-blind, placebo-controlled, Austrian Phase II trial to evaluate 87.6 mg AP301 delivered via aerosol by nebulizer technology every 12 hours for up to 7 days in about 40 patients with pulmonary edema....

A double-blind, placebo-controlled, dose-escalation, Austrian Phase I trial in 48 healthy volunteers showed that single doses of 4-120 mg AP301 delivered via aerosol by nebulizer technology were well tolerated with no serious adverse side effects...

Apeptico began a double-blind, placebo-controlled, dose-escalation, Austrian Phase I trial to evaluate a single dose of AP301 delivered via aerosol by nebulizer technology in up to 48 patients with lung infection, lung injury or lung...

In a rat model of lung transplantation, AP301 significantly improved lung oxygenation after 24 hours vs. an inactive mutant form of the 17-amino acid cyclic peptide. AP301 also significantly reduced neutrophil content and reduced reactive...

FDA granted Orphan Drug designation to Apeptico's AP301 to prevent ischemia reperfusion injury in the lung during lung transplantation. The human tumor necrosis factor (TNF) alpha-derived peptide also has Orphan Drug designation in Europe to...

EMEA's Committee for Orphan Medicinal Products (COMP) issued a positive opinion to grant Orphan Drug designation for Apeptico's AP301 to treat acute lung injury. The human tumor necrosis factor (TNF) alpha-derived peptide is in preclinical...