What happened
Shares of Seres Therapeutics (NASDAQ: MCRB) went Monday after the biotech company announced promising results from a Phase 3 study of its experimental therapy for obese infections. From 3:35 a.m. EDT, Seres‘share was up 350% after going up as much as 611% earlier in the day.
So what
Seres said the administration of its oral microbiome therapeutic, labeled SER-109, resulted in a 30.2% decrease in the number of patients undergoing a recurrence of C. difficile infection (CDI) over a period of eight weeks, compared to a placebo. The drug was also well tolerated, with no serious unusual events reported during the study.
The stock of Seres Therapeutics shook higher Monday. Image Source: Getty Images.
Seres also said the results of the study support his request for a breakthrough therapy designation from the U.S. Food and Drug Administration. “We are very pleased with these highly clinically significant SER-109 Phase 3 study results, which exceed the statistical threshold provided by the FDA,” said CEO Eric Shaff in a press release. “Based on our prior discussions with the FDA, we believe this trial should provide the effectiveness basis for submitting an application for product approval.”
Well what
The market potential for experimental treatment of Seres could be huge. Roughly 170,000 people in the U.S. suffer from recurrent CDIs each year, according to Seres’ chief medical officer Lisa von Moltke.
Better yet, the medicine could have an enormous impact on the lives of the people struggling with the disease. “Recurrent C. difficile infection is a serious disease that destroys the viability of patients, and in many severe cases can result in the death of a patient,” University of Leeds professor of medical microbiology Mark Wilcox said in the release of Seres . “Today’s treatment options have significant shortcomings related to efficacy, safety, and route of administration, and new approaches that address the root causes of the disease are urgent.”
