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).
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.
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