We recently had the opportunity to speak with Dr. Denis Evseenko, a professor of orthopedic surgery, stem cell research, and regenerative medicine at the Keck School of Medicine, about the research. In the Q&A, Dr. Evseenko discusses the poten…
FDA authorization of vilobelimab signals new opportunities for drug developers in inflammatory diseases
The FDA has granted InflaRx (Nasdaq:IFRX) emergency use authorization (EUA) for the monoclonal antibody Gohibic (vilobelimab) to treat critically-ill COVID-19 patients. The company’s shares were up yesterday almost 84% to $3.77. Today, its shares jumped an additional 62% to $6.10.
The EUA represents a significant advance for the Jena, Germany–based company, which on March 31, 2022, encountered a setback related to the antibody. At that time, the company announced that vilobelimab failed a topline readout for critically ill intubated patients suffering from COVID-induced pneumonia in the phase 2/3 PANAMO study. Later, however, InflaRx reported in a predefined analysis without site-stratification that vilobelimab significantly decreased all-cause mortality at 28 days. While the initial protocol did not require site-stratification, the company amended the protocol based on regulators’ recommendations.
Regulatory nod for vilobelimab could spark new developments …Stelara shows promise for long-term management of ulcerative colitis
Janssen’s (NYSE:JNJ) Stelara supported corticosteroid-free remission in about half of ulcerative colitis patients in a 152-week long-term extension UNIFI study.
At the end of the nearly three-year study, 55.2% of volunteers were in symptomatic remission. Of those patients, 96.4% were corticosteroid-free at week 152. Janssen, which is part of Johnson & Johnson, presented the data today at the Congress of the European Crohn’s and Colitis Organisation (ECCO).
Stelara (ustekinumab) enabled more than half of the patients in the trial to achieve remission without the need for steroids. That fact is one of the most critical findings in the recent data, said Dr. Jan Wehkamp, VP and gastroenterology disease area leader at Janssen.
While the human body naturally produces steroids, long-term use of corticosteroids leads to significant side effects in most people. They can lead to everything from high blood pressure, elevated blood sugar, glaucoma and other prob…