Shares of San Diego’s Prometheus Biosciences jumped more than 200 percent this week following positive results from clinical trials for its therapies targeting inflammatory bowel diseases.
The young biotech firm, which went public in February 2021 at $19 a share, announced on Tuesday initial results from Phase 2 studies for its therapy for treating ulcerative colitis and Crohn’s disease, where some people struggle to find medications that work.
U.S. Food and Drug istration approval of the treatment is not assured, and even if that comes actual sales could be far off. But Prometheus’s shares — which ended trading on Monday at $37.66, just before the results were announced — closed Thursday at $117.21 on the Nasdaq exchange.
Early data from the 120-patient ulcerative colitis study showed that Prometheus’s monoclonal antibody therapy candidate achieved a 26.5 percent remission rate for patients with moderate-to-severe disease who had failed to benefit from other therapies, compared with 1.5 percent remission rate for placebo patients.
The same monoclonal antibody was also studied for Crohn’s disease in a separate clinical trial with 55 patients. It showed significant benefits on biomarkers associated with inflammation and fibrosis. The study also achieved a 49 percent remission rate, compared with a pre-determined historical remission rate of 16 percent.
Both studies showed Prometheus’s therapies have a clean safety profile. The results put the therapies in the “best-in-class” category compared with currently approved medications, said Annabel Samimy, managing director at Stifel, in a research report.
“We are thoroughly impressed with Prometheus’s first major data read-out …. in ulcerative colitis and Crohn’s disease, with both far exceeding expectations,” she said. “While the inflammatory bowel disease treatment landscape is crowded, there are few treatments that have broken through the 15 percent clinical remission rate, specifically in ulcerative colitis.”
Phase 2 studies do not mean a drug is ready to come to market anytime soon. Prometheus must complete larger, more rigorous Phase 3 trials and seek approvals from the FDA.
Prometheus plans to launch Phase 3 trials next year. It said Thursday that it will sell $250 million in a public stock offering to finance the effort.
The company specializes in precision medicine in inflammatory diseases. It has developed a database of over 200,000 samples over two decades and taps machine learning to uncover targeted therapies.
“What the industry has been looking for is an agent with disruptive efficacy and a favorable safety profile that can have a more meaningful impact on patients,” said Mark McKenna, chief executive of Prometheus, in a conference call with analysts. “It is early, but it is very encouraging.”
