COVID-19 Investigational Therapy Shows Encouraging Data

Apeiron Biologics AG announced encouraging data with its clinical drug candidate, APN01 (rhsACE2) to treat severe COVID-19. The case involves a 45-year old woman who was admitted to the hospital who developed pneumonia and tested positive for COVID-19.

The findings were published in The Lancet Respiratory Medicine.

The patient was admitted to the hospital with a 7 day history of cough, weakness, myalgia, fever, and dyspnoea. She also had a 4 day history of nausea and diarrhea. The next day, the patient’s condition worsened and she was put on a ventilator.

The attending physicians, family, and infectious disease experts conferred and decided upon a course of treatment for compassionate use. An investigational therapy, APN01, developed by Apeiron was started with intravenous infusion for 5 min twice daily. The investigators reported the patient became afebrile within hours.

The next day the patient’s temperature went up suggesting bacterial pneumonia. She was treated with cefuroxime.

Along with a long hospital stay, the patient dealt with some complications including methicillin-sensitive Staphylococcus aureus (MSSA).

“Therapy with hrsACE2 [APN01] was continued as planned for 7 days and was well tolerated without obvious drug-related side effects," the investigators wrote.

Some of the key takeaways from this case study with regard to the APN01 infusion included 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.

"Her clinical course was complicated by slowly resolving pneumonia with repeated detection of MSSA in tracheal suctions and Enterobacter aerogenes bacteremia, and her antibiotics were changed to linezolid and aztreonam,” the investigators wrote. “Her clinical condition improved gradually and extubation was done on day 21 after baseline. The patient was then transferred to neurological rehabilitation for treatment of critical illness myopathy, which improved after physiotherapy."

After 57 days in the hospital, she was discharged.

APN01 is a recombinant form of the human angiotensin-converting enzyme 2 (rhsACE2), and this compound is the crucial severe acute respiratory syndrome SARS-CoV-2 receptor and protects multiple tissues, including the lung from injury as a regulator of the renin—angiotensin system.

“ACE2 is at the center of COVID-19 research and drug development," lead author Alexander Zoufaly, MD, Department of Infectious Diseases/Clinic Favoriten, said. "In this instance, we have now provided first data on soluble ACE2 therapy in a patient with SARS-CoV-2 infection. The results from this named patient use are encouraging and support the rationale to further explore APN01 as a therapy to treat COVID-19 in clinical trials.”

APN01 is in a company-sponsored phase 2 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.

Aperion is based in Vienna, Austria and specializes in the discovery, development and commercialization of novel immunotherapies for cancer and respiratory diseases.