Study with “Penninger drug” starts in Austria, Germany and Denmark

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Study with “Penninger drug” starts in Austria, Germany and Denmark – the most important things at the beginning:

Regulators approved the start of a clinical trial to treat COVID-19 patients. The drug is said to block the virus and reduce lung damage.

Authorization to treat COVID-19

Regulators in Austria, Germany and Denmark have approved the start of a phase II clinical trial to treat COVID-19 patients, a press release said. The drug was developed by Josef Penninger and his team at Apeiron Biologics AG. This is to block the infection and reduce lung damage. In Austria, the study is funded by the government.

“The drug candidate APN01 (rhACE2) is a synthetic enzyme with the potential to block the infection of cells by the novel virus SARS-CoV-2 and to counter inflammatory reactions in the lungs. The phase II trial will treat 200 patients with COVID-19. ”

Double mechanism of action

APN01 has a double mechanism of action. On the one hand, it mimics the human enzyme ACE2. The virus needs this to penetrate the cells. The virus should therefore bind to the soluble form of the enzyme injected into the patient and not to the original version of the body cells. On the other hand, the enzyme is said to reduce inflammatory reactions in the lungs, which builds up protection against acute lung damage and shortness of breath.

Josef Penninger, co-inventor of APN01, founder and board member of Apeiron Biologics AG and professor at the University of British Columbia, said in an interview: “It would then be like a sponge that absorbs the virus and prevents it from docking on the body cells and to go into the cells. “
Penninger also says: “ACE2 is essential for the infection pathway of the SARS-CoV, which triggered the SARS epidemic in 2003. The new coronavirus strain SARS-CoV-2 also needs the ACE2 receptor to infect human cells. I am therefore confident that our recombinant ACE2 can be successfully used to treat COVID-19: we block the door for the virus and protect the organs. ”

“Because of its unique dual mechanism of action, APN01 could become the first drug to treat COVID-19 that targets the new coronavirus SARS-CoV-2.
Treatment of the first patients in our Phase II trial is expected to begin quickly to quickly and safely create effective treatment options for seriously ill COVID-19 patients in need of help. We are very grateful for the enormous support from the regulatory authorities in Austria, Germany and Denmark, who made this study so quick as possible, and for the strong commitment of the Austrian federal government, which will also support our study financially, “said Peter Llewellyn- Davies, CEO of Apeiron Biologics AG in the broadcast.

Preparatory work had already been done in 2005

Penninger’s work from 2005 made it possible for the study to start quickly. Here he discovered that the “first” SARS coronavirus docks on the surface of the enzyme ACE2, thus multiplying in the body cells and making the infected ill.
A study phase today is no longer necessary, since the tolerance and safety of the substance was already tested on 89 healthy volunteer patients. It has been shown to be tolerable and safe.

Study at ten locations in Austria, Germany and Denmark

A total of 200 patients at ten locations in Austria, Germany and Denmark are now to be treated in a placebo-controlled, double-blind, randomized phase II study. The study aims to evaluate the clinical efficacy of APN01 as well as safety and tolerability in seriously ill COVID-19 patients.

Promising study

In Austria, the Medical University of Vienna, the Kaiser Franz Josef Hospital in Vienna, the Medical University of Innsbruck and the University Hospital Salzburg are taking part in the study.

“We are delighted to be able to participate in this promising study. APN01 is a well-developed drug candidate with a convincing, dual principle of action that could make an important therapeutic contribution in the COVID-19 pandemic, ”said Henning Bundgaard, lead investigator for the study and professor at the Faculty of Health and Medical Sciences at the University of Copenhagen.

The study must now show whether these expectations are also confirmed in everyday clinical practice.

Around 160 studies for therapies and vaccines worldwide

Many studies are currently underway to develop therapies and vaccines.
According to the WHO, two vaccine candidates are currently in clinical trials, which means that they are already being tested on humans.

Alexander Herzog, Secretary General of Pharmig (Association of the Austrian Pharmaceutical Industry), is enthusiastic: “Never before have pharmaceutical companies and research institutions reacted to a new pathogen as quickly as this time to Sars-CoV-2. There is an impressive worldwide collaboration between companies , Government agencies, science, health care systems and politics to jointly manage the effects of Covid-19. “

Stefan Kähler, chairman of the responsible Pharmig committee for clinical research estimates the time for the first available vaccine to be around one year.

“It has to be secure and able to be made available on a large scale. Drugs that have already been approved for other diseases could be a little faster, between six months and a year, ”says Kähler. “It depends on how many patients you can include in the studies.”

If active ingredients have already been used in other areas, you already know their safety profile and can therefore more easily create a risk-benefit assessment.

Source: Kurier.at
Product image: Shutterstock / lovelyday12

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