PLATFORM & PIPELINE
At Crestovo, we are leveraging our industry-leading Full-Spectrum Microbiota™ (FSM™) platform to develop therapeutics that harness the human gut microbiome to restore diversity of healthy microorganisms. Through this approach, we are working to treat conditions with significant unmet medical need where patients are suffering from dysbiosis, including recurrent Clostridium difficile infection (CDI).
Crestovo’s platform builds off of proven in-human efficacy, and leverages the principles of gut microbial diversity to develop a class of therapeutics on our Full-Spectrum Microbiota™ platform:
Simpler, more convenient administration via capsule that avoids conventional invasive techniques (e.g. retention enema, nasogastric tube, colonoscopy or self-administered enema)
Harnesses broader microbiota diversity, which has been shown to produce fuller, more rapid restoration of gut flora
Novel processing method ensures longer product life and enhances commercial and distribution viability
By successfully engrafting in the host microbiome, our FSM™ platform has the potential to generate therapies that cure disease, prevent future onset, improve patient health and enhance quality of life.
CP101 (PRISM 3)
CP101 is Crestovo’s potential first-in-class, lead Full-Spectrum Microbiota™ (FSM™) candidate generated from the company’s industry-leading platform. As an orally-administered product, CP101 contains the full complement of functional microorganisms to help restore a dysbiotic microbiota (or microbial imbalance) to a normal, functioning gut microbial community. Beyond CP101, Crestovo is developing a pipeline of FSM™ therapeutics to treat a range of serious diseases.
- PRISM 3 (Preventing Recurrence of Clostridium difficile infection using Full-Spectrum MicrobiotaTM) is Crestovo’s clinical trial in patients with recurrent Clostridium difficile infection (CDI)
- Crestovo announced the patients had been dosed in June 2017
- PRISM 3 is a multicenter, randomized, placebo-controlled trial to evaluate the efficacy and safety of CP101 in approximately 240 patients with recurrent CDI at clinical sites throughout the US
- Primary endpoint is prevention of recurrence of CDI through eight weeks following administration of CP101, compared to placebo
The trial is actively enrolling patients, with top-line data expected in 2018. For more information on PRISM 3, please visit clinicaltrials.gov.
Crestovo is in active clinical collaborations on additional indications of interest. Stay tuned for more.