Date: 2014-10-30
Type of information: Results
phase: 2a
Announcement: results
Company: Anamar (Sweden)
Product: AMAP102
Action
mechanism: AnaMar\'s lead 5-HT2B receptor antagonist, AMAP102, is an orally bioavailable small molecule in early Phase 2a exploratory development for inflammatory pain in osteoarthritis. AMAP102 demonstrates disease inhibition and tissue protection in arthritis animal models, and reduction of IL-6, TNF-alpha and other inflammatory mediators in relevant human and animal in vitro models. AMAP102 inhibits inflammatory mediated pain in relevant animal models and has successfully completed Phase 1 clinical testing without any serious adverse events or clinically relevant safety findings.
Disease: inflammatory pain in osteoarthritis
Therapeutic area: Rheumatic diseases - CNS diseases
Country:
Trial details:
Latest
news: * On October 30, 2014, AnaMar announced top-line results from an exploratory Phase 2a double-blind, placebo-controlled, parallel-group, randomized study evaluating the efficacy, safety and tolerability of AMAP102 for the treatment of inflammatory pain in 116 patients suffering from mild to moderate osteoarthritis (OA) of the knee, either with or without hand OA. In the reported exploratory Phase 2a trial, AMAP102, a 5-HT2B receptor antagonist, was well tolerated with no reported serious adverse events, but fell short of demonstrating a statistically significant reduction in pain over a 28-day period compared to placebo, as measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC®) pain subscale. However, preliminary results from subgroup analyses indicate potential efficacy in patients with higher levels of inflammation. Ongoing analyses are expected to confirm these early and encouraging findings. Leif E. Dahlberg, Ph.D., Professor of Orthopaedics at Lund University in Sweden, stated, \"We look forward to receiving the individual patient data and final subgroup analyses from this exploratory Phase 2a trial, which will be reported before year end. AMAP102 has demonstrated significant disease inhibition and tissue protection in arthritis animal models, and reduction of IL-6, TNF-alpha and other inflammatory mediators in relevant human and animal in vitro models. It therefore remains a viable candidate for continued clinical testing as there is much need for disease-modifying osteoarthritis drugs.\"
