AnaMar’s AMAP102 fails to meet primary endpoint in exploratory Phase IIa trial

2nd November 2014 (Last Updated November 2nd, 2014 18:30)

Swedish biopharmaceutical firm AnaMar has reported top-line results from an exploratory Phase IIa trial of AMAP102, a 5-HT2B receptor antagonist, to treat inflammatory pain in patients suffering from mild to moderate osteoarthritis (OA) of the knee, either with or without hand OA.

Swedish biopharmaceutical firm AnaMar has reported top-line results from an exploratory Phase IIa trial of AMAP102, a 5-HT2B receptor antagonist, to treat inflammatory pain in patients suffering from mild to moderate osteoarthritis (OA) of the knee, either with or without hand OA.

OA is a leading cause of joint pain and physical disability in working age adults and elderly retirees, and it is the most common form of arthritis that affects more than 150 million across the globe.

The double-blind, placebo controlled, parallel-group, randomised trial evaluated the efficacy, safety and tolerability of AMAP102 in 116 patients.

The trial showed that AMAP102 was well tolerated with no reported serious adverse events, but failed to meet primary endpoint of showing 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.

"The double-blind, placebo controlled, parallel-group, randomised trial evaluated the efficacy, safety and tolerability of AMAP102 in 116 patients."

The company said that preliminary results from subgroup analyses indicate potential efficacy in patients with higher levels of inflammation.

Lund University in Sweden professor of Orthopaedics Leif Dahlberg said: "We look forward to receiving the individual patient data and final subgroup analyses from this exploratory Phase IIa 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-a 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."

The company is seeking and currently assessing potential partnerships to help leverage and maximise its proprietary peripheral 5-HT receptor platform and speed up the development and commercialisation of its proprietary pipeline of high-potential 5-HT2B receptor antagonist therapeutic candidates.

AnaMar CEO Owe Gårlin said: "AM1030-CREAM, containing a novel 5-HT2B receptor antagonist specifically selected by AnaMar, based on its cytokine reduction profile and anti-inflammatory properties, is scheduled to commence clinical testing before year end.

"The Phase Ib/IIa placebo-controlled, topical SAD/MAD, safety, tolerability and PK/PD study will investigate AM1030's suppression of inflammation and itching in atopic dermatitis patients. Having already received ethics committee approval, this study is now awaiting final regulatory clearance."