Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Arena Pharmaceuticals' APD371 investigational pain drug candidate has passed the early-stage test after the company reported favorable results from the phase 1b clinical trial of the cannabinoid 2 (CB2) receptor.
Subscribe to our email newsletter
APD371 is the company’s internally discovered investigational drug candidate aimed at treating pain and potentially other indications.
The compound, via its selectivity, is designed to offer pain relief without psychotropic effects, loss of efficacy over time, or the reliance, abuse potential or adverse event profile related with other pain treatments.
The placebo-controlled Phase 1b clinical trial looked at 36 healthy adults to assess the safety of multiple-ascending doses of APD371 and demonstrated only low-level adverse events.
Subjects received either 50 mg, 100 mg or 200 mg of APD371 or placebo three times per day for 10 days.
Adverse events were all mild with the most common being headache and nausea. The company said reductions in blood pressure and heart rate were observed, but none were symptomatic.
There was one discontinuation in the 200 mg cohort because of mild thirst and drowsiness.
Arena Pharmaceuticals senior vice president and chief medical officer William Shanahan said: "The results of this trial substantiate data from our single-ascending dose trial of APD371.
"In both trials, we achieved dose-responsive exposure without dose-limiting adverse events across the range studied."
Preclinical efficacy with APD371 has been demonstrated in animal models of osteoarthritic and neuropathic pain.
The US Food and Drug Administration or any other regulatory agency have not yet approved APD371.
Image: APD371 is Arena Pharmaceuticals’ internally discovered investigational drug candidate aimed at treating pain and potentially other indications. Photo: courtesy of zole4/FreeDigitalPhotos.net.