ASP7962 / Astellas - LARVOL DELTA

OAK: A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee (clinicaltrials.gov) - P2 | N=215 | Completed | Sponsor: Astellas Pharma Europe B.V. | Phase classification: P2a ➔ P2

Phase classification • Back Pain • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Neurotoxicity studies with a tropomyosin-related kinase A inhibitor, ASP7962, on the sympathetic and sensory nervous systems in rats. (PubMed, Toxicol Lett) - "There were no test article related changes in the brain, dorsal root ganglia with spinal nerve roots or trigeminal ganglia and no functional deficits. ASP7962 did not cause any detectable dysfunction of the sympathetic and sensory nervous system in either study."

Journal • Immunology • NGF • NTRK • NTRK1

Tropomyosin-related Kinase A (TrkA) Inhibition for the Treatment of Painful Knee Osteoarthritis: Results From a Randomized Controlled Phase 2a Trial. (PubMed, Osteoarthritis Cartilage) - P2a | "Four-week treatment with ASP7962 (100 mg BID) did not improve pain or physical function in individuals with painful knee osteoarthritis. ClinicalTrials.gov, NCT02611466; EudraCT Number, 2014-004996-22."

Clinical • Journal • P2a data • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

MAD: A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Multiple Ascending Doses of ASP7962 in Healthy Subjects (clinicaltrials.gov) - P1; N=48; Completed; Sponsor: Astellas Pharma Europe B.V.; Recruiting ➔ Completed

Trial completion • Biosimilar

TrkA inhibitor disappoints in knee osteoarthritis trial (Medicine Matters Rheumatology) - P2, N=127; NCT02611466; Sponsor: Genzyme; "...Tuhina Neogi...suggest that '[s]tudy population differences between the trials might have contributed to better signal detection over placebo in the trial of GZ389988A.' They explain that the GZ389988A trial excluded patients with high neuropathic-like pain scores, and included 'only participants with minimal pain in the contralateral knee.'"

Media quote • P2 data