Date: 2016-04-12
Type of information: Results
phase: 1b
Announcement: results
Company: Arena Pharmaceuticals (USA - CA)
Product: APD371
Action
mechanism: cannabinoid receptor agonist. APD371 is an orally available agonist of the CB2 receptor is Arena's internally discovered investigational drug candidate for several potential indications, including pain and fibrotic diseases. This compound, through its high level of observed selectivity for the CB2 receptor versus the CB1 receptor, is designed to provide pain relief without psychotropic effects or the potential for dependence or abuse. Preclinical efficacy with APD371 has been shown in animal models of osteoarthritic and neuropathic pain.
Disease: pain
Therapeutic area: CNS diseases
Country:
Trial details:
Latest
news: * On April 12, 2016, Arena Pharmaceuticals announced results from its Phase 1b multiple-ascending dose clinical trial of APD371, a highly selective and potent agonist of the cannabinoid 2 (CB2) receptor with potential utility in the treatment of pain. This randomized, double-blind, placebo-controlled Phase 1b clinical trial enrolled 36 healthy adults to evaluate the safety, tolerability and pharmacokinetics of multiple-ascending doses of APD371. Cohorts of 12 subjects (9 active, 3 placebo) were administered doses of 50 mg, 100 mg, or 200 mg of APD371 or placebo three times daily for 10 days and, in connection with the pharmacokinetic evaluation, one time on the 11th day. The most common adverse events were headache and nausea. All adverse events were classified as mild, and there were no serious adverse events reported. There was one discontinuation in the high-dose group due to an adverse event of mild thirst and somnolence. Reductions in blood pressure and heart rate were observed, but none were symptomatic or resulted in an adverse event. Drug levels at all doses tested in the trial, including the lowest dose, were well above those believed to be needed to stimulate the CB2 receptor. * On October 29, 2015, Arena Pharmaceuticals announced the initiation of patient dosing in a Phase 1b multiple-ascending dose clinical trial of APD371. This randomized, double-blind, placebo-controlled Phase 1b clinical trial will enroll approximately 36 healthy adults to evaluate the safety, tolerability and pharmacokinetics of multiple-ascending doses of APD371. In a previous single-ascending dose trial, APD371 demonstrated dose responsive exposure over the explored range of 10-400 mg with good tolerability at all doses.
