Sparrow Pharmaceuticals Initiates Second Cohort in Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica

Sparrow Pharmaceuticals, a biopharmaceutical company, recently announced the initiation of its second cohort in a Phase 2 clinical trial of SPI-62 with prednisolone for the treatment of polymyalgia rheumatica (PMR). PMR is a chronic inflammatory disorder that affects the muscles and joints, causing pain and stiffness.

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety and efficacy of SPI-62 in combination with prednisolone in patients with PMR. The trial will include approximately 60 patients who will be randomly assigned to receive either SPI-62 in combination with prednisolone or placebo. The primary endpoint of the trial is the change in disease activity score from baseline to week 12. Secondary endpoints include changes in patient-reported outcomes, including pain, stiffness, and fatigue.

The first cohort of the trial was initiated in February 2021 and is expected to be completed in June 2021. The second cohort is expected to be completed in August 2021. If the results of the trial are positive, Sparrow Pharmaceuticals plans to submit a New Drug Application to the U.S. Food and Drug Administration for approval of SPI-62 for the treatment of PMR.

Sparrow Pharmaceuticals is committed to developing innovative treatments for PMR. The company has already developed a novel drug candidate, SPI-62, which has shown promising results in preclinical studies. The Phase 2 clinical trial is an important step in the development of SPI-62 as a potential treatment for PMR. If successful, SPI-62 could provide a new option for patients with PMR who are seeking relief from their symptoms.

Original Post Date: October 2, 2020

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