Candidate: APN01

Type: Recombinant human angiotensin-converting enzyme 2 (rhACE2) developed to treat acute lung injury, acute respiratory distress syndrome, and pulmonary arterial hypertension.

APN01 is designed to imitate the human enzyme ACE2 so that the virus can no longer infect the cells, as SARS-CoV-2 binds to soluble ACE2/APN01 instead of ACE2 on the cell surface. APN01 is also designed to reduce harmful inflammatory reactions in the lungs and protects against acute lung injury/acute respiratory distress syndrome (ALI/ARDS).

Status: APEIRON said June 3 it had launched a Phase II clinical trial of APN01 to treat COVID-19 (NCT04335136) in Austria, Denmark, Germany, and the U.K, with plans to expand the study into the U.S. and Russia. The trial aims to compare APN01 to placebo in up to 200 severely infected COVID-19 patients at 10 sites. APEIRON received regulatory approvals for the trial in Austria, Germany, and Denmark in April.

Also in June, APEIRON completed a financing round totaling €17.5 million ($20.2 million), toward further development of APN01 for the treatment of seriously ill COVID-19 patients, as well as the further development of immuno-oncology projects. The financing consisted of €5.6 million ($6.5 million) in public funding and guarantees from the Austrian Research Agency (FFG), the Vienna Business Agency (WAW), the Austria Economic Service Company (AWS) and Erste Bank—and €11.9 million ($13.7 million) raised as part of a rights issue with a private placement from existing and new private and institutional investors, including the Vienna Insurance Group (VIG).

VIG will receive a 3.26% stake in APEIRON following an investment of approximately €7 million ($8.1 million) in the company.

APN01 has been shown to be safe and well-tolerated in a total of 89 healthy volunteers and patients with pulmonary arterial hypertension (PAH) and ALI/ARDS in previously completed Phase I and Phase II clinical trials, APEIRON said.

In March, The First Affiliated Hospital of Guangzhou Medical University disclosed on ClincalTrials.gov that a planned open label, randomized, controlled, pilot clinical study of APN01 in patients with severe SARS-CoV-2 infection had been withdrawn without Chinese Center for Drug Evaluation (CDE) approval. No explanation has been given on the company’s website or on ClinicalTrials.gov. The trial was designed to obtain preliminary biologic, physiologic, and clinical data in patients with COVID-19 treated with rhACE2 or control patients, to help determine whether a subsequent Phase IIb trial is warranted.

Suzhou-based Angalpharma coordinated the Chinese clinical trial, with support from dMed Pharmaceutical, a CRO based in Shanghai.


COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:

● ANTIVIRAL
● VAX
● ANTIBODY
● RNA

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