Sparrow Pharmaceuticals Expands Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica with Second Cohort
Sparrow Pharmaceuticals, an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both rheumatology and endocrinology, has expanded its Phase 2 clinical trial (NCT number: NCT05436652) of prednisolone in combination with SPI-62 for the treatment of polymyalgia rheumatica (PMR) with the introduction of a second cohort to the study.
“This trial is expected to teach us whether SPI-62 can separate the desired and undesired effects of prednisolone,” said David Katz, PhD, Chief Scientific Officer of Sparrow. “Since the first clinical use almost 75 years ago, a goal of rheumatologists has been to deliver the potent efficacy of glucocorticoids to control autoimmune and inflammatory disorders yet spare patients the adverse symptoms associated with those drugs.”
“The management of conventional glucocorticoids includes giving as little as possible but as much as necessary,” said Prof. Dr. med Frank Buttgereit, Principle Investigator for the trial in Germany. “Another innovative way to potentially optimize treatment with these highly effective drugs derives from knowledge of their metabolism, or more precisely, HSD metabolism.”
In this multi-center trial, multiple markers of prednisolone efficacy (e.g., erythrocyte sedimentation rate, C-reactive protein) and toxicity (e.g., oral glucose tolerance test, osteocalcin) will be measured in two 2-week periods during which patients will receive either SPI-62 or matching placebo in addition to prednisolone. Twelve additional patients will be enrolled in this second cohort. Patients with PMR taking a daily 10mg oral dose of prednisolone may be eligible for the trial.
SPI-62 is Sparrow’s potent and selective investigational HSD-1 inhibitor that is also in Phase 2 development for Cushing’s syndrome and autonomous cortisol secretion, in addition to PMR. For the PMR trial a fixed-dose combination of prednisolone and SPI-62 will be referred to as SPI-47. HSD-1, an intracellular enzyme, activates glucocorticoids in target tissues in which glucocorticoid medicines are associated with morbidity including liver, adipose, muscle, and skin.
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