Seres, Vera Notch Weekend Wins in C.Diff, Lupus Trials
Two exploratory drugs for hard-to-treat diseases are advancing to the next stages of development.
Seres Therapeutics shared positive results from its Phase III ECOSPOR trial for the prevention of recurrent C. difficile infection. SER-109 is an oral microbiome therapeutic made up of Firmicutes spores, typically found in healthy microbiomes. It is designed to resist the colonization and growth of Clostridioides difficile, thus preventing the recurrence of infection. The SER-109 purification process removes unwanted microbes to reduce pathogen transmission risks that donor screening might not catch.
SER-109 already has Breakthrough Therapy and Orphan Drug designations from the U.S. Food and Drug Administration. Seres is now preparing to file a Biologics License Application by mid-2022. If approved, the drug could be a first-in-class microbiome therapeutic.
Details of the latest developments were shared at the Digestive Disease Week Annual Meeting through an oral presentation on the impact of SER-109 on stool fatty acid metabolites in recurrent CDI and a poster presentation on the durability of SER-109 engraftment through 24 weeks.
"These data reinforce our strongly-held belief in the power of the microbiome, and we are hopeful of delivering the first-ever FDA-approved microbiome therapeutic, a potentially transformative treatment option to patients in need," Seres Chief Medical Officer Lisa von Moltke, M.D. said in a statement.
The second weekend win went to Vera Therapeutics, which announced new clinical data from its potential drug candidate, atacicept, from prior studies in both IgA Nephropathy (IgAN) and systemic lupus erythematosus (SLE).
Atacicept is a recombinant fusion protein currently under investigation to treat IgAN and lupus nephritis. It was previously evaluated in several studies, including Phase IIa JANUS, which tested atacicept in patients diagnosed with IgAN and Phase II APRIL-SLE, which looked into its effect on SLE. New analysis of findings from both trials were presented at France's European Renal Association - European Dialysis Transplant Association Congress.
"We are excited to share these new data from the Phase 2a JANUS clinical trial which we believe make atacicept the first known investigational therapeutic to reduce IgG autoantibodies as well as its autoantigen, Gd-IgA1," Vera Chief Medical Officer Dr. Celia Lin said in a press release.
"We also presented new data from a post-hoc analysis from our double-blind, placebo-controlled Phase 2 study which suggested atacicept has the potential to improve renal function in patients with mild-to-moderate SLE renal disease," Lin added.
Aside from these two trials, Vera is assessing atacicept for the treatment of moderate-to-severe lupus nephritis in its Phase III COMPASS study and is planning to conduct more research into the drug's potential to treat serious kidney diseases.