Response Pharmaceuticals announced that the Phase Ib clinical trial yielded positive results for RDX-002, a novel treatment aimed at preventing antipsychotic-induced weight gain (AIWG).

RDX-002 is a first-in-class candidate treatment for the prevention of rapid weight gain associated with the leading antipsychotic medications.  

It is a potent, selective, and gut-specific small molecule inhibitor of the microsomal triglyceride transfer protein (MTP). It is intended to reduce the amount of triglycerides and cholesterol absorbed by the body after meals.

During the two-week open-label Phase Ib trial, 24 healthy, antipsychotic-naïve volunteers were treated with olanzapine, which is associated with AIWG, for one week.

Following this, the subjects were randomised at the study outset to either add RDX-002 orally twice a day to OLAN or continue on OLAN alone during week two.

The RDX-002 cohort subjects met the primary endpoint for efficacy, reducing postprandial triglycerides (ppTGs).

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In an AIWG exploratory analysis, subjects receiving OLAN alone saw significant weight gain during the first and second weeks of treatment. There was no significant weight change in the RDX-002 cohort in the second week.

Exploratory analyses provided additional insights. The olanzapine-only group saw a mean body weight increase of 1.6kg in the first week and an additional 1.7kg in the second week. In contrast, the group treated with RDX-002 showed only a 0.4kg increase in the second week.  

Response Pharmaceuticals chief science officer and RDX-002 lead inventor Dr Paul Sweetnam said: “This study provides the first clinical evidence of increased post-prandial lipids with antipsychotic medications, suggesting upregulation in iMTP from antipsychotics may play a role in the rapid weight gain associated with these medications.

“Treatment with the iMTP-inhibitor RDX-002 significantly reduced ppTGs and blunted the weight gain in OLAN-treated subjects, indicating a potential role in the treatment and prevention of AIWG.”

Response Pharmaceuticals is preparing for a Phase II clinical trial of RDX-002, which will be a placebo-controlled, 12-week study focusing on weight gain and ppTGs changes in patients beginning olanzapine therapy for bipolar depression and schizophrenia.

The company is also seeking Series B funding.