Sparrow Pharmaceuticals Doses First Patient in Phase 2 Clinical Trial of SPI-62 with Prednisolone for Polymyalgia Rheumatica
Portland, Oregon, September 9, 2022 — Sparrow Pharmaceuticals, an emerging, clinical-stage biopharmaceutical company developing novel, targeted therapies to address unmet needs in both rheumatology and endocrinology, today announced that the first patient has been dosed in a phase 2 clinical trial (NCT number: NCT05436652) of prednisolone in combination with SPI-62, Sparrow’s potent and selective investigational HSD-1 inhibitor, for the treatment of polymyalgia rheumatica (PMR), a common autoimmune disease that causes widespread muscle pain and stiffness primarily in adults over 50. A fixed-dose combination of prednisolone and SPI-62 will be referred to as SPI-47.
“Millions of people with PMR must choose between living with the debilitating symptoms of their disease or suffering the severe side effects of glucocorticoid, or steroid, medicines such as prednisolone, as steroids are the only approved treatment,” said David Katz, PhD, Chief Scientific Officer of Sparrow. “Both clinical and animal study results suggest that SPI-62 can mitigate steroid adverse impact, such as insulin resistance, increased adiposity, muscle atrophy, and fracture risk, yet not meaningfully alter steroid efficacy to relieve inflammatory symptoms. This trial will be the first to evaluate steroid efficacy and toxicity in patients with an autoimmune disease in the presence of a HSD-1 inhibitor. If we observe separation of the desired from undesired effects of prednisolone, we’ll be an important step closer to solving a decades-old puzzle in autoimmune disease treatment.”
“Glucocorticoids (e.g. prednisolone, cortisone) are indispensable medicines worldwide. They work quickly, are universally applicable, inexpensive, and very effective. Unfortunately, their use has serious side effects,” said Dr. med. Andrea Everding, Hamburg Rheumatology Research Center. “Development of a well-tolerated glucocorticoid would be a groundbreaking discovery and could be a real breakthrough in the treatment of our patients. We are doing all we can to support this innovative development.”
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. Up to 48 patients will be enrolled. Six clinical sites in Germany are active. Patients with PMR taking a daily 10mg oral dose of prednisolone may be eligible for the trial.
