APEIRON Biologics’ APN01 Selected for US COVID-19 Trail

APEIRON Biologics, a private European biotech company, announced next steps for APN01 (alunacedase alfa) for COVID-19 treatment. Based on the results from APEIRON’s Phase 2 trial with COVID-19, APN01 will be developed in further clinical trials with different COVID-19 patient populations and drug delivery routes. 

APN01 is a soluble recombinant human Angiotensin-Converting Enzyme 2 (rhACE2) which mimics ACE2, the cellular entry receptor for the SARS-CoV-2 virus. The virus’ spike uses the ACE2 protein to enter the cells. APN01, as a soluble form of ACE2, potentially prevents binding of the virus spike protein to the cell surface receptor and thereby preventing infection of cells.

Human ACE2 is a key enzyme regulator of the Renin-Angiotensin-Aldosterone System (RAAS), a peptide system involved in blood pressure, lung disorders, diabetic kidney disease, inflammation, or cardiovascular diseases. ACE2 directly affects RAAS and reduces blood pressure, inflammation, and protects the heart, kidney, liver, lung and vasculature from damage. Thus, in addition to blocking the access of SARS-CoV-2 to its cell membrane-bound entry gate, APN01 potentially leads to a reduction of organ injuries in COVID-19. 

APEIRON’s recently completed Phase 2 trial showed significant improvement in certain parameters of the Renin-Angiotensin-Aldosterone System (RAAS) with APN01 treatment compared to placebo. 

“Administering APN01 earlier in the course of COVID-19 potentially protects patients from progressing to a severe stage of the disease with uncontrollable inflammation and organ damage,” said Peter Llewellyn-Davies, Chief Executive Officer of APEIRON Biologics. “We are confident that this Phase 2 US trial will confirm the clinical benefits of APN01.”