This is potentially the first therapy seeking FDA-approval utilizing human gut microbiome.
Crestovo doses recurrent Clostridium difficile infection (C. difficile) patients in PRISM 3, a phase 2 clinical trial testing CP101 (Microbiota).
The company is developing a Full-Spectrum Microbiota that harnesses the human gut microbiome. CP101, a first-in-class, lead microbiome therapy, is an encapsulated, single dose, orally-administered medicine that contains the full complement of functional microorganisms that may help restore the dysbiotic microbiota to a normal, functioning gut microbial community.
“CP101 has the potential to be the first therapy seeking FDA-approval utilizing the human gut microbiome,” Joseph Lobacki, chief operating officer, interim chief executive officer, Crestovo, said.
PRISM 3 is a multicenter, randomized, placebo-controlled trial evaluating the efficacy and safety of Microbiota in approximately 240 patients with recurrent C. difficile at clinical sites throughout the US.
Primary outcomes include a proportion of patients with no recurrence of symptomatic, laboratory confirmed C. difficile infection through 8 weeks, following administration of Microbiota, compared to the placebo, as well as a proportion of participants with adverse effects assessed by CTCAE v4.0 through 8 weeks mapped to system organ class.
Secondary outcome measures include a proportion of subjects sustaining clinical cure by a C. difficile subtype; through week 8, time to first recurrent C. difficile during the study at week 8 and 24; and a proportion of patients with no recurrence of symptomatic, laboratory confirmed infection at week 24.
Study arms include high dose full spectrum Microbiota, low dose full spectrum Microbiota and a placebo.
Inclusion criteria includes the ability to provide written informed consent, men or women 18—85 years age, a current diagnosis of a recurrence of non-severe, non-complicated C. difficile, and a clinical response to a standard course of oral vancomycin therapy to treat the current episode of recurrent C. difficile.
Top-line data from PRISM 3 is expected to release in December 2018.
A press release was made available.