InflaRx stock halves after it drops lead drug
InflaRx has taken the difficult decision to abandon its drug development programme, vilobelimab, for rare inflammatory skin disorder pyoderma gangrenosum (PG), a move that has pummelled its share price.
The Germany-based but Nasdaq-listed biotech said that, after reviewing data from the first 30 patients enrolled in its phase 3 trial of anti-complement C5a monoclonal antibody vilobelimab in PG, its expert advisors had advised it to discontinue the study.
Based on a futility analysis, InflaRx will no longer develop vilobelimab for PG, which causes painful, fast-growing ulcers to appear on the body that can take a long time to heal and leave scars.
Treatment of PG is currently limited to immune-suppressing drugs and antibiotics to treat complicating infections, and, in severe cases, the ulcers may need surgery to resolve, so the demise of vilobelimab is a crushing blow to people living with the disease.
In a statement, InflaRx said it is now switching its attention to INF904, an oral C5a-targeting drug with phase 2a data readouts expected in the next few months in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS).
At the time of writing, InflaRx's shares were down more than 53% in premarket trading to $0.85 after closing at $1.82 yesterday, giving the company a valuation of $122 million.
Vilobelimab is available in the US under an emergency use authorisation as a treatment for COVID-19 in hospitalised adults needing respiratory support, under the Gohibic brand name, and is also approved in Europe for exceptional use in people with acute respiratory distress syndrome (ARDS).
InflaRx said it will continue a phase 2 trial sponsored by the US federal government, looking at its potential as a treatment for ARDS, which started last year.
"While the outcome is not what we had hoped it would be, InflaRx remains committed to its goal of developing new therapies for underserved patients with chronic immune-dermatological conditions," said chief executive Prof Niels Riedemann.
The demise of the PG programme has raised the spectre of a cost-reduction drive at the company, which ended the first quarter of this year with just under €66 million (about $75 million) in cash reserves that it said were sufficient to fund operations into 2027.
Today, it said it is "considering additional cost savings and redirection of resources toward the goal of extending the company's existing cash runway."
