Policy & Regulation
The Lancet Publishes Promising Data of Apeiron's APN01 (rhsACE2) to Treat COVID-19 in Named Patient Use
24 September 2020 - - The first, encouraging data with Austrian private biotechnology company Apeiron Biologics AG's clinical drug candidate APN01 (rhsACE2) to treat severe COVID-19 were published in the peer-reviewed journal The Lancet Respiratory Medicine 1, the company said.

The Case Report describes the first treatment of a patient suffering from severe COVID-19 with APN01 in named patient use.

The data published show the expected observations of an adaptive immune response, a rapid loss of virus load and reduction in inflammatory mediators, and the development of high titers of neutralizing antibodies against SARS-CoV-2 leading to a significant clinical improvement of the patient treated.

Key findings of the publication: APN01 (soluble ACE2) infusion showed the expected enzymatic activity and modulation of the renin angiotensin system.

The APN01 infusion correlated with a gradual reduction in levels of multiple disease relevant inflammatory mediators over the studied time period.

The infusion of APN01 also correlated with a rapid loss of detectable viremia and slightly delayed reduction in viral titers in tracheal samples and nasopharyngeal swaps.

APN01 infusion was fully compatible with an adaptive immune response and the development of high titers of neutralizing antibodies against SARS-CoV-2.

APN01 / alunacedase alfa (rhsACE2) is a well-advanced drug candidate for the treatment of COVID-19 and one of the few therapeutic approaches specifically directed against the corona virus.

According to experts, if the current Phase II study is positive, accelerated market approval could probably take place.

The company-sponsored Phase II trial is ongoing in Austria, Germany, Denmark, UK, and Russia and is expected to be expanded to the US. The double-blind, randomized, placebo-controlled study aims to treat 200 patients with severe COVID-19 disease.

The specific targeting of SARS-CoV-2 by APN01 was recently confirmed by preclinical results published in the peer-reviewed publication CELL 2.

Apeiron Biologics AG is a European private biotechnology company based in Vienna, Austria, that specializes in the discovery, development and commercialization of novel immunotherapies for cancer and respiratory diseases. APEIRON's APN01 / alunacedase alfa (rhsACE2) is undergoing a Phase II trial to treat COVID-19.

Apeiron has an approved product on the market, Qarziba, for the treatment of pediatric neuroblastoma patients, which is distributed by EUSA Pharma.

The company's clinical program APN401 is a first-in-class autologous cellular therapy to strengthen immune reactivity via targeting the intracellular master checkpoint, Cbl-b.


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