COVID-19 med APN01 selected to be tested in ACTIV study
Apeiron Biologics announced that an expert panel has selected its clinical COVID-19 treatment APN01 to participate in the Phase II US ACTIV-4d RAAS trial, which is aimed to accelerate the development of the most promising treatments able to restore balance to the Renin Angiotensin Aldosterone System (RAAS) in COVID-19 patients. Primary endpoint is oxygen free days through 28 days. Secondary endpoints include in hospital mortality, use of mechanical ventilation, and WHO scale scores.
APEIRON Biologics has already completed a Phase II trial that showed promising antiviral activity of APN01 (alunacedase alfa) and significant improvement in certain parameters of the RAAS when given early after infection up to WHO score 4. The randomized, double-blinded, placebo controlled ACTIV-4d RAAS trial, which is funded with $60m of federal money, will enroll approximately 1,600 hospitalized patients with COVID-19, at more than 50 individual sites. APN01 will be one of at least three agents to be evaluated in the trial.
As APN01 (alunacedase alfa) mimics the ACE2 cell entry receptor SARS-CoV2 binds to, it might act as a soluble decoy for the viral spike protein that blocks the virus from binding to the cellular receptor without inducing any selection pressure leading to drug resistant variants. Furthermore, ACE2 dials down the RAAS and thereby could reduce blood pressure, diminishes inflammation, and protects multiple organs such as the heart, kidney, liver, lung or vasculature from damage.
"We are very excited about being selected for the ACTIV programme, and for good reason," said Peter Llewellyn-Davies, Chief Executive Officer of APEIRON Biologics AG. "The trial will recruit so many patients that no biotech company could enrol on its own. We are confident that this Phase 2 US trial will confirm the clinical benefits of APN01 in the treatment of COVID-19 patients and opens the US and international markets for our promising drug candidate," he added.
According to Llewellyn-Davies, "COVID-19 will not disappear despite vaccination, because there will always be people who get sick - because they cannot be vaccinated, the effectiveness of the vaccine may decrease, or because vaccine-resistant variants appear. In internal tests with variants, rACE2 was shown to be effective against all variants of concern. "That's why it's important to push forward with drug development to the same extent as vaccine development right from the start", stressed Llewellyn-Davies.
In parallel to the US clinical trial with APN01, for which the company is scaling up a process for commercial production, APEIRON is preparing a Phase 1 trial to evaluate an inhalable formulation of APN1 to target infected or high-risk patients earlier in the course of the disease. Preliminary data demonstrated high efficacy in SARS-CoV-2 animal models. A Phase 1 inhalation study is expected to start in Q3/2021. It will form the basis for further development in chronic respiratory diseasessuch as Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Arterial Hypertension (PAH).