GSK plc (NYSE:GSK) on Friday announced a pivotal update regarding its Phase 3 clinical program for camlipixant, revealing a strategic decision to halt further development for refractory chronic cough (RCC).
The decision follows inconsistent data from two late-stage trials, which indicated that the medication’s limited effectiveness would likely fail to significantly improve current standard care for the complex condition.
Mixed Results From Phase 3 CALM Trials
The UK pharmaceutical giant evaluated the safety and efficacy of two distinct doses of camlipixant, a P2X3 receptor antagonist, across its CALM-1 and CALM-2 Phase 3 studies. The trials yielded contrasting outcomes for the higher dose of the medication.
In the CALM-1 study, a 50mg twice-daily dose successfully achieved its primary goal, demonstrating a statistically meaningful reduction in 24-hour cough frequency compared to a placebo after 12 weeks of treatment.
However, the CALM-2 trial failed to mirror this success, as the same 50mg dosage did not achieve statistical significance at the 24-week mark.
Furthermore, a lower 25mg twice-daily dose failed to meet the primary efficacy targets in both clinical trials.
Crucial secondary measurements, such as the Chronic Cough Diary assessment, also fell short of their designated target thresholds across both studies.
Safety Profiles And Future Indications
Despite the efficacy shortcomings, the clinical trials demonstrated a favorable safety profile for the drug.
The overall frequency and intensity of side effects related to the treatment were comparable between the patients who received camlipixant and those given a placebo.
Because the cumulative data suggested the drug would not transform patient care, the company chose to discontinue the RCC program.
However, the data gathered from the CALM program will be submitted for future publication and presentation to aid scientific research into RCC, which remains a poorly understood disease with sparse therapeutic options.
Meanwhile, camlipixant remains active in the company’s pipeline for other indications.
The Phase 2b BALANCE clinical trial will persist in studying the drug’s safety and effectiveness for adult patients diagnosed with diarrhea-predominant irritable bowel syndrome and mixed irritable bowel syndrome.
GSK Stock Price Activity: GSK shares were down 1.97% at $51.73 at the time of publication on Friday, according to Benzinga Pro data.
Image via Shutterstock
