CIN-103 is a novel formulation of phloroglucinol modified to enhance the pharmacokinetic properties to sustain the therapeutic exposure for patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
Phase 2
CIN-103
OVERVIEW:
CinPhloro’s CIN-103 is a novel, small-molecule, modified pulsatile-release formulation of phloroglucinol – a phenol-derivative with antispasmodic properties. In pre-clinical studies, CIN-103 has demonstrated to impact intestinal motility, secretion, pain, spasms & inflammation. Phloroglucinol is approved in several countries in Europe for the treatment of gastrointestinal disorders.
Employing an extrusion-spheronization process, CinPhloro’s scientific and pharmacology team went through an extensive formulation process to reach a desired pharmacokinetic profile by combining immediate and delayed release technology.
CIN-103 has progressed from concept through Phase I Multiple Ascending Dose (MAD) trials demonstrating the desired PK profile. Phase I results demonstrated evidence of enhanced PK release profile based upon the novel CinPhloro formulation as well as decreased GI motility, secretion, pain, spasm and inflammation.
CIN-103 will be studied in additional clinical trials to be initiated in 2023.
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
