Apeiron Respiratory Therapies (Arest), a subsidiary of Invios, announced that a Phase 1 SAD/MAD study of its APN01 nebulized alunacedase alfa in 40 healthy subjects met all endpoints. Both Arest and Invios were spun off from the original developer of APN01, Apeiron Biologics, earlier this year. Arest is developing APN01, a soluble recombinant human angiotensin converting enzyme 2 (ACE2), for the treatment of respiratory diseases, including COVID-19.
Principal Investigator Markus Zeitlinger of the Medical University of Vienna commented, “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.”
Arest Chief Medical and Scientific Officer Romana Gugenberger 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.”
Invios CEO Peter Llewellyn-Davies added, “We are pleased with the results of this study, as it opens numerous additional avenues for the further development of APN01. With the current trial of inhaled APN01 and our previous Phase 2 trial using intravenous administration in COVID-19, we have shown that APN01 is a safe and well tolerated potential treatment approach for a number of respiratory diseases. We are therefore actively reviewing out-licensing options to drive the further development of APN01, and welcome additional expressions of interest from potential partners.”
Read the Invios press release.
