US biotech company CinDome Pharma has enrolled the first patient in a phase 2 clinical trial which will evaluate its investigational gastroparesis drug deuterated domperidone (CIN-102).
Considered to be a debilitating, chronic condition, gastroparesis impacts the stomach muscles and leads to improper emptying of the stomach.
Deuterated domperidone (CIN-102), which has been developed through deuteration – a process in which specific hydrogen atoms in the chemical structure of domperidone are replaced with deuterium atoms.
The investigational gastroparesis drug is a peripherally selective dopamine (D2/D3) receptor antagonist. According to CinDome Pharma, deuterated domperidone is expected to produce prokinetic effects in gastroparesis patients, while addressing the symptoms associated with the stomach disorder.
Non-deuterated domperidone, a well-known D2/D3 receptor antagonist, is used in several parts of the world for the treatment of nausea and vomiting and gastroparesis.
CinDome Pharma had wrapped two phase 1 clinical trials of CIN-102 and is now initiating its phase 2 clinical programs.
The phase 1 clinical program was made up of a single ascending dose (SAD) study from 5 mg to 120 mg of the investigational gastroparesis drug and a multiple ascending dose study (MAD) up to 60 mg BID in healthy subjects.
In the two placebo-controlled phase 1 clinical trials, no safety concerns were observed. Within the expected therapeutic dose range of CIN-102, there was a significant reduction in maximum plasma concentrations in comparison to therapeutic doses of non-deuterated domperidone.
Plasma concentrations were also maintained more with the half-life being more than two times than what is usually seen with non-deuterated domperidone. Additionally, there was evidence of elevation of prolactin at all dose levels and regimens studied, which indicated appropriate target engagement. The pharmacodynamic (PD) effect on prolactin levels indicates an identical efficacy profile compared to non-deuterated domperidone.
Commenting on the phase 2 trial of gastroparesis drug CIN-102, Richard W. McCallum – the lead principal investigator on one of the two phase 2 trials said: “We are encouraged by the safety, pharmacokinetics, and pharmacodynamic data obtained following administration of single doses and multiple doses of CIN-102 in the Phase 1 studies to date.
“Gastroparesis is an area of unmet medical need, as the therapies currently available in the U.S. are limited and can cause undesirable side effects.”
For more updates on the phase 2 trial of gastroparesis drug CIN-102 by CinDome Pharma, keep following Pharma News Daily.