Food and beverage giant Nestlé has entered into an agreement with microbiome therapeutics company Seres Therapeutics Inc. to jointly commercialize the company’s investigational oral microbiome drug for recurrent Clostridioides difficile infection (CDI) in the US and Canada.
The agreement expands on an existing strategic partnership between the two companies that was struck back in 2016. The deal involved Nestlé gaining commercialization rights outside of the US and Canada for four experimental drugs: Seres’ SER-287 and SER-301 for irritable bowel disease and SER-262 for C. difficile, as well as SER-109.
CDI is a leading cause of hospital-acquired infections in the US that claims the lives of more than 20,000 people in the country each year. The infection is marked by severe diarrhea and can lead to life-threatening inflammation of the colon.
Under the agreement, Nestlé Health Science will utilize its global pharmaceutical business Aimmune Therapeutics and will take on the role of lead commercialization party.
CDIs usually develop after treatments with antibiotics as they can kill off healthy bacteria in the gut in the process of targeting the pathogenic bacteria. To help restore the microbiome, SER-109 is an oral microbiome drug that delivers purified Firmicutes spores in capsule form. Firmicutes microbes are an important protective species in the gut and are also involved in the life cycle of C. difficile and disease pathogenesis.
SER-109 “repopulates” the microbiome to induce compositional and functional changes that are critical to a sustained clinical response.
As part of the deal with Nestlé, Seres will receive license payments of $175 million up front with an additional $125 million upon FDA approval of the drug. The agreement also includes sales target milestones which, if achieved, could total up to $225 million, Seres outlined in a news release from the company.
Seres says it will cover all development and pre-commercialization costs in the US, and upon commercialization, it will be entitled to 50 percent of the commercial profits.
“Nestlé Health Science has been a terrific collaborator in our quest to develop a new treatment option for patients suffering from recurrent C. difficile infection, and their support over the past few years has been critical in advancing SER-109 to address this unmet need,” Seres Therapeutics CEO, Eric Shaff, said in the news release.
“We conducted a competitive process to select a collaborator for SER-109. As we prepare for potential approval and commercialization, we are eager to embark side-by-side on our next phase with a company that believes as fervently as we do in the potential of this transformative approach to reduce the recurrence of CDI.”
Nestlé echoed Seres, as CEO of Nestlé Health Science, Greg Behar, said, “We are excited to expand our existing collaboration with Seres Therapeutics at this pivotal time, given the promise SER-109 holds for patients trapped in the debilitating cycle of recurrent C. difficile infection,”
Nestlé’s Aimmune Therapeutics has developed a strong footing in the area of gastroenterology, allowing it to lead the commercialization of SER-109 while Seres is able to maintain a strategic role and actively participate in the launch.
The commercialization efforts are supported by data from a late-stage study released last year that showed patients taking SER-109 were significantly less likely to see their C. difficile infections return.
The data, released in August 2020, was from the pivotal Phase III ECOSPOR III study in which the primary endpoint was met: a highly statistically significant reduction in the rate of CDI recurrence compared to placebo was seen at eight weeks, with an absolute reduction of 27 percent and a relative risk reduction of 68 percent.
Around 88 percent of patients achieved sustained clinical response at week eight in a separate measure. The randomized study involved 182 patients who received either SER-109 or placebo. The trial is now continuing as an open-label trial where all patients have access to SER-109.
Seres plans to use the data from the study to file for FDA approval and as part of the agency’s approval requirements, will treat at least 300 patients with the drug and monitor them for 24 weeks. Seres says it expects that the ECOSPOR III efficacy results should support a BLA filing as a single pivotal trial once it meets the trial requirements. Seres anticipates reaching target enrolment in Q3 of 2021.
Microbiome restoring drugs for the treatment of C. difficile appear to be gaining momentum. Last year, Finch Therapeutics announced positive Phase II trial results for its investigational oral microbiome drug CP101 for C. difficile. Following this, the company secured $90 million in Series D financing in September 2020, including from new investors, to advance its pipeline of oral microbiome drugs.
Similarly, the late-stage clinical microbiome company Rebiotix, which is a Ferring Company, announced positive Phase III clinical trial results in May of this year of its oral microbiome-based therapeutic RBX2660 that was shown to reduce C. difficile infection over a period of six months.