Shares of Seres Therapeutics (NASDAQ: MCRB) rose on Monday after the biotechnology company announced promising results from a phase 3 study of its experimental therapy for colon infections. From 15.35 EDT, creaturesthe stock rose 350% after rising as much as 611% earlier in the day.
Seres said that the administration of its oral microbiome therapeutically, labeled SER-109, resulted in a 30.2% reduction in the number of patients who experienced a recurrence of C. difficile infection (CDI) within an eight-week period, compared to a placebo. The drug was also well tolerated, with no serious side effects reported during the study.
Seres also said the results of the study support its request for a breakthrough treatment designation from the U.S. Food and Drug Administration. “We are extremely pleased with these highly clinically meaningful SER-109 Phase 3 study results, which greatly exceed the statistical threshold provided by the FDA,” said CEO Eric Shaff in a press release. “Based on our previous discussions with the FDA, we believe that this review should provide an efficiency basis for submitting an application for product approval.”
The market potential for Sere’s experimental treatment may be significant. About 170,000 people in the United States alone suffer from recurrent CDIs each year, according to Sere’s chief physician Lisa von Moltke.
Even better, the drug can have a huge impact on the lives of the people struggling with the disease. “Recurrent C. difficile infection is a serious disease that destroys patients’ quality of life, and in many severe cases can lead to the death of a patient,” said University of Leeds professor of medical microbiology Mark Wilcox in Sere’s release. “Today’s treatment options have important shortcomings related to efficacy, safety and route of administration, and new approaches to the root causes of the disease are urgently needed.”