Seres Therapeutics Inc (NASDAQ:MCRB) (STI) reported a drop of 51.75% YoY to $6.45 million in Q2 2020.
STI expects to post SER-109 Phase 3 Clinical trial results soon. The study is being conducted in recurrent CDI (C. difficile infection). SER-109 consists of purified and commensal bacteria-derived from spore. It is manufactured in a GMP certified facility by STI to ensure product consistency and quality. To improve the safety of the product, STI uses a unique production process to inactivate the potential pathogens like SARS-COV2 and Escherichia coli, non-spore bacteria species.
The positive data from ECOSPOR III will help advance therapy for the community with CDI, a deadly and debilitating disease. An FDA approved treatment is necessary to prevent the recurrence of CDI.
A positive data from ECOSPOR III will also mark an important event for the company for its microbe therapeutics pipeline. STI expects to submit regulatory filing using this positive data with the US FDA seeking approval for its SER-109 product.
Advances therapeutic product family
CEO of STI, Eric D Shaff, said the Phase 3 clinical study of the SER-109 will help the company to offer the best therapy approved by the US FDA to address the underlying cause of this disease. He further said the progress achieved with SEFR-109 helps STI advance its therapeutic product series SER-401, SER-301, SER-287, and SER-155. Each of these microbe candidates is developed to target devastating diseases.
SER-301 – a promising clinical candidate
The clinical candidate SER-301 is used for curing ulcerative colitis. It is the fermented, rationally designed microbiome therapeutics for oral administration. STI used innovative production techniques for the manufacture of SER-301. It comprises strains provided in spore form and strains fermented in vegetative and in non-spore form. The product is designed to deliver bacteria in the colon. It plays a vital role in modifying the microbe related and microbiome metabolites in the patient’s gastrointestinal tract. The product improves the integrity of the epithelial barrier in patients who have ulcerative colitis and modulates the pathways associated with gastrointestinal inflammation.
The clinical development of SER-301 is underway, and STI is making preparations for conducting phase 1 clinical study in patients suffering ulcerative colitis.