The founder and CEO of Inflarx sees hope in the drug for seriously ill Covid patients.
(Photo: InflaRx)
Frankfurt An approval success that many investors no longer expected gave the German biotech company Inflarx a price jump of more than 80 percent on the US stock exchange Nasdaq on Tuesday evening. The American drug agency FDA granted the drug Gohibic, developed by Inflarx, emergency approval for the treatment of seriously ill Covid patients. Inflarx stock then rose from $2.05 to $3.77 in late trading.
In the future, Gohibic can be used in patients who need mechanical ventilation due to the disease. For the young company from Jena, it is the first successful approval ever and thus also an important confirmation of the underlying research approach in the field of inflammatory diseases.
The drug with the active ingredient vilobelimab aims to block the messenger substance C5a, which is considered the most important activator of the innate immune system. It is present in particularly high concentrations in pneumonia and is therefore considered to be largely responsible for the overactivity of immune cells and inflammatory factors, which in some Covid patients leads to the destruction of lung tissue and the dreaded acute respiratory distress syndrome (ARDS).
dampen immune response
Antiviral drugs such as Pfizer’s Paxlovid are of no use to such patients. Rather, the challenge at this stage of the disease is to dampen an excessive immune response.
Inflarx founder and CEO, Niels Riedemann, says the approval is recognition of the “life-saving potential of this first-in-class compound.” He points out that around 2,000 Covid deaths per week are still being reported in the USA. Seriously ill Covid patients could be offered a new hope. “We are working hard to make the treatment available to patients as quickly as possible,” says Riedemann.
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In Germany, according to data from the Robert Koch Institute, 566 people have died in connection with a Covid infection in the past seven days. Almost 1000 Covid patients are then currently being treated in intensive care.
Inflarx tested vilobelimab in a study with almost 370 critically ill, ventilated Covid patients in Europe, South America, South Africa and Russia. For the patients treated with vilobelimab, there was a relative reduction in the risk of death of 24 percent after 28 days.
The company is also developing vilobelimab for other uses. Among other things, a larger phase 3 study is planned for the treatment of pyoderma gangrenosum, a chronic inflammation of the skin that leads to painful ulcers and is triggered by an excessive immune response.
Inflarx still far from previous stock market rating
The attempt to develop the active ingredient against chronic inflammation of the sebaceous glands, on the other hand, had already failed in 2019, which cost Inflarx a drop of around 90 percent and the loss of around one billion euros in market value. With Tuesday night’s jump, Inflarx stock has recovered significantly from its lows, but is still a long way off previous highs of over $40.
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The company is now valued at around $168 million (around €154 million). At the end of 2022, Inflarx employed 48 people. In addition to Gohibic/Vilobelimab, Inflarx is also working on two other C5a inhibitors, which are still in the preclinical or early phase of clinical tests.
Investors’ confidence in the German biotech company was not particularly high recently, especially since the US competitor Veru failed with another drug against the most severe Covid diseases at the beginning of March despite positive efficacy data from the FDA. Similar to Veru, there were certain doubts about the validity of the clinical data in the case of Inflarx’s drug. But unlike the US competitor, Inflarx was apparently able to dispel these doubts.
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