Biosplice Therapeutics is attempting to clear its late-stage knee osteoarthritis treatment after other biopharmas have reached snags in the past year, and it now has $140 million worth of confidence with a partner in China.
Haisco Pharmaceutical will dole out that figure, including $20 million in upfront and early development milestones, to license the treatment candidate for knee osteoarthritis and other musculoskeletal conditions in China, the companies said Wednesday.
Biosplice signed a similar agreement with Samil Pharmaceutical for $70 million in aggregate value in April. Samil got the right to develop and commercialize the treatment in Korea (PDF). Those deals add to the $120 million in equity financing Biosplice hauled in in April (PDF).
The San Diego biotech's lorecivivint showed significant and long-term improvements in pain and function outcomes reported by patients with knee osteoarthritis in phase 2 studies (PDF), Biosplice said.
Lorecivivint could be "the first novel drug therapy for osteoarthritis in nearly 20 years," Biosplice claimed. Biopharmas have hit some major failures in late-stage trials in the past year for the indication, potentially providing a pathway for Biosplice to tap into a patient population of more than 32 million people in the U.S. alone.
Bone Therapeutics reported a phase 3 failure for its osteoarthritis treatment last month, hitting neither primary nor secondary endpoints in a trial of more than 700 patients. Further yet, Galapagos and Servier failed to improve outcomes in patients with the degenerative joint disease in a phase 2 trial last October.
Despite setbacks for biopharmas, the medical technology field recently cleared a major hurdle for these patients. CyMedica's drug-free muscle-stimulating system got the FDA green light in June.
Biosplice hopes to compete against current treatment options—like cortisone injections, joint replacements and pain relievers—with a small-molecule kinase inhibitor that modulates the Wnt pathway.
Wnt proteins help spur tissue remodeling. The treatment aims to decrease cartilage breakdown and also inhibit the DYRK1A kinase, leading to STAT3 inhibition for an anti-inflammatory response. In turn, that results in near-term pain relief and functional improvement, Biosplice said.
Lorecivivint is currently in four phase 3 trials, including a three-year, open-label study; an extension study looking at second year use of the drug; a 28-week study evaluating the drug's safety and efficacy for a single injection that is slated to end this month; and a 56-week study in patients with symptomatic knee osteoarthritis, which was expected to end last month.
Further down its pipeline, Biosplice has a phase 1 oncology asset among other preclinical oncology targets and a preclinical neurology program targeting Alzheimer's disease and traumatic brain injury.