July 29, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. -- Roger Pomerantz, chief executive officer of microbiome company Seres Therapeutics , earned $700,000 in stock sales two days before the company reported its Phase II C. diff trial failed to meet its efficacy endpoints of reducing recurrence of the disorder.
Shares of Seres, a Flagship Ventures company, have plummeted more than 75 percent this morning following the revelation. Shares are currently trading at $9.87, down from Thursday’s close of $25.77 per share.
Pomerantz and two other executives sold shares of company stock on Wednesday, according to a report this morning from The Street’s Adam Feuerstein. Sales of the stocks were performed under pre-programmed trading plans and were legal, Feuerstein said, but he said the timing of the deal will likely anger shareholders who have lost a considerable amount today. The other two executives were not named in the article.
Seres is developing therapies targeting the human microbiome, the bacteria residing in the human gastro-intestinal track, with a particular focus on C diff., ulcerative colitis, as well as some work on immunology and metabolic diseases. Its lead therapy, SER-109, which earned it a breakthrough therapy designation from the U.S. Food and Drug Administration, was unable to statistically outperform placebo. Following an eight-week regiment, the company said 44 percent of patients taking SER-109 saw a recurrence of C. diff., while 53 percent of placebo patients saw a recurrence of the issue.
“These are unexpected clinical results in view of the positive data in our prior investigator-sponsored Phase Ib trial, as well as in a wide range of supporting clinical and preclinical data,” Pomerantz said in a statement. “Our priority is to complete a full review of the clinical results and microbiome data of the Phase II study and to compare it to data from the prior investigator sponsored Phase Ib. Based on this information and pending discussions with the FDA, we plan to make any necessary changes to our development plans for SER-109.”
No drug-related serious adverse events were observed during the trial, the company said.
In addition to SER-109, Seres is developing SER-262, a synthetic therapy for primary C. diff, a first-time diagnosis. These oral therapies are considered to be one-shot treatments that will replicate within the GI tract and stave off any future occurrences, Carlo Tanzi, head of investor relations at Seres told BioSpace in a previous interview.
Last year, Seres struck a $1.9 billion deal with Nestle Health Science to further develop treatments for C. diff and inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.
The failure of SER-109 could halt some of the booming growth Seres has seen over the past year. In November, Seres signed a lease to take over 83,000 square feet of space in the old Vertex building in Cambridge to add new laboratory and office space. The company has also been hiring new talent to support its expanded work, nearly tripling employment over the past year.
