Response Pharmaceuticals, Inc. today announced the successful completion of its Phase 1B clinical trial for the company's lead drug candidate, RDX-002, a first-in-class inhibitor of intestinal microsomal triglyceride transfer protein (iMTP). While full results are being analyzed, RDX-002 was generally well tolerated, and the study met its primary objective. The company is working with its scientific team and advisory board to complete the data analysis and prepare the final full results.

Response Pharmaceuticals' Phase 1B trial was a 2-week open-label study in antipsychotic-naïve, healthy volunteers. All subjects were initially treated with olanzapine, a widely used anti-psychotic with a well-documented side effect of weight gain, for one week, before one cohort continued to receive olanzapine alone and the second cohort received RDX-002 and olanzapine. The study's primary objective was to measure the effect of RDX-002 on postprandial triglyceride levels. The study's results will be used to direct the design of a robust Phase 2 study where RDX-002 will be co-administered in patients with schizophrenia initiating treatment with olanzapine.

"We are extremely excited about completing this first clinical trial of RDX-002 for the indication of antipsychotic-induced weight gain. This serious side effect is commonly observed with multiple antipsychotic drugs which treat debilitating mental diseases and often results in non-compliance with treatment." said Chief Medical Officer Bill Sasiela, who continued "Intestinal MTP is an exciting therapeutic target with potential to address unmet needs in a wide range of metabolic indications. We are extremely pleased that we have met our primary objective in this first trial and are working to complete analysis of the complete data package."

The Company expects to be able to report complete trial results and Phase 2 development plans in September 2023.

 

Source:prnewswire.com

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