CIN-103
OVERVIEW:
CinPhloro’s CIN-103 is a novel formulation of phloroglucinol – a non-opioid based, small molecule approved in select countries for the treatment of GI disorders. Designed for long-term use, CinRx’s non-clinical & early development team deployed immediate-release and delayed-release processes to formulate a proprietary, pulsatile release delivery offering sustained drug exposures with less frequent dosing. CIN-103 is believed to target multiple IBS-D action points, including motility, secretion, pain, spasms and inflammation.
CIN-103 has progressed from concept through Phase I Multiple Ascending Dose (MAD) trials. Phase I data demonstrated a superior PK profile compared to phloroglucinol, without the anticholinergic side effects associated with other antispasmodics.
CinPhloro is currently enrolling the enviva clinical trial. The Phase 2 enviva study is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of multiple dose strengths of CIN-103 in adults with IBS-D over 12 weeks of treatment. The study endpoints include patients’ clinical response relative to placebo on abdominal pain and stool consistency (as a composite responder). The trial aims to enroll 450 participants. More information can be found at www.envivastudy.com or NCT Number NCT06153420.
IBS-D
Metrics:
Prevalence between 10%-15% in North America
Affects approximately 16.2M in the US
Most common reason for a referral to a gastroenterologist
REASONS
TO BELIEVE
- High unmet medical need as none of the approved therapies offer optimal efficacy and safety
- Currently available treatments for IBS-D rely on individualized therapies using a variety of different medications and dietary modifications
- phloroglucinol is an antipasmodic with none of the anticholinergic side effacts associated with other classes of antispasmodics
- The impoved formulation allows for decreased frequency of dosing
- Regulatory approval is belived to be highly attainable based upon precedent / despite placebo effact in published data
