APEIRON Respiratory Therapies announces positive results from Phase I trial of inhaled APN01

APEIRON Respiratory Therapies announced positive final results from a Phase I clinical trial of inhaled APN01 (alunacedase alfa), a soluble recombinant version of the SARS-CoV-2 cell entry receptor ACE2.

The study met all primary and secondary endpoints, with all results indicating that the inhalation of APN01 at all dosage levels used in the trial is safe and well tolerated. In the study, no dose-limiting toxicities were observed. No serious adverse events were reported, and no patients withdrew from the trial.

Professor Markus Zeitlinger, Head of the Department of Clinical Pharmacology at the Medical University of Vienna and Principal Investigator for the study, said: “I am very happy that our team was able to contribute to the development of this potential treatment for patients suffering from different forms of severe respiratory disease. The inhaled route of administration may enable the achievement of very high concentrations at the site of action, without compromising patient safety due to systemic side effects. We were able to confirm a good tolerability profile from a clinical perspective.”

Dr Romana Gugenberger, Chief Medical and Scientific Officer of AResT, said: “The results of this study allow further clinical development of novel inhaled APN01 and expand its potential as a treatment for a range of respiratory diseases. In addition to meeting all primary endpoints regarding the safety and tolerability of APN01 via a new route of administration, the observed low systemic concentrations of ACE2 indicate that inhaled APN01 may be an effective treatment for chronic conditions such as pulmonary arterial hypertension as well as acute indications like COVID-19.”

In a completed double-blind, placebo-controlled Phase 2 trial, intravenously administered APN01 showed potential clinical benefit against COVID-19. The drug candidate also may have potential in other respiratory diseases such as acute respiratory distress syndrome (ARDS) and pulmonary arterial hypertension (PAH).

APN01 was previously developed by APEIRON Biologics AG, a privately held biotech company based in Vienna, Austria, and out-licensed to AResT, which was demerged from APEIRON Biologics AG in 1H 2022 to continue the development of APN01. AResT is a 100% subsidiary of invIOs GmbH (“invIOs”), which was also demerged from APEIRON Biologics AG in 1H 2022 to focus on the discovery and development of innovative cancer immunotherapies.