An infectious disease expert and former head dealmaker at Merck & Co is racing against his ex-employer and other drugmakers to develop a treatment for a germ that ravages the colon and kills as many as 14,000 Americans each year.
Roger Pomerantz on Monday became chief executive officer of privately held Seres Health, whose lead product has proven highly effective against the c. difficile bacteria in early-stage clinical trials.
The condition occurs in patients who have been treated with broad-spectrum antibiotics that kill off "friendly" bacteria in the gut, allowing c. difficile to take root and prosper there. It causes colitis, including serious diarrhea and fever that can recur and are not well-controlled by current treatments.
The infections, which are most dangerous for the elderly and others with weakened immune systems, typically occur in hospitals, nursing homes and doctor's offices, but are becoming more common in the community at large.
Some industry analysts have said effective treatments against c. difficile could have blockbuster sales potential.
The Seres oral capsule, called SER 109, in early clinical trials quickly eliminated symptoms in more than 90 percent of patients, Pomerantz said in a telephone interview. All patients previously had multiple recurrences of c. difficile after standard antibiotic treatments such as vancomycin and metronidazole.
Rather than killing c. difficile, SER 109, which contains spores from bacteria initially harvested from human stool, restores balance to the microbiome, where millions of types of bacteria interact in the colon, Pomerantz said.
"There's no ick factor," he said. "There's no stool in our capsules, just (bacterial) spores" that have been replicated countless times on laboratory dishes, refined and purified.
Mid-stage trials of SER 109 involve about 40 patients and are being conducted at numerous centers, including the Mayo Clinic and Massachusetts General Hospital. They should be completed in the next six weeks, after which Seres aims to conduct late-stage studies, Pomerantz said.
"We have multiple large pharmaceutical companies interested in our company," Pomerantz said, but he would not comment about any possible licensing plans.
Merck's injectable treatment, called MK-3415A, is a combination of two monoclonal antibodies that do not target c. difficile itself but instead block toxins produced by the germ. It is now in late-stage studies.
Pomerantz, who once headed infectious disease research for class="mandelbrot_refrag">Johnson & Johnson, joined Merck in 2010 in a similar capacity. Soon afterward he took charge of business development, overseeing licensing deals and acquisitions.
But he left Merck last summer after an executive reshuffling and in November became chairman of Cambridge, Massachusetts-based Seres, a role he retains.
Pomerantz said SER 109 and other Seres products also could treat diabetes, obesity and metabolic syndrome, diseases the microbiome is believed to affect.
(Reporting by Ransdell Pierson; Editing by Lisa Von Ahn)