Addex Partner Starting Clinical Schizophrenia Trial
Addex Pharmaceuticals announced the start of a Phase IIa clinical trial of ADX71149 for the treatment of schizophrenia. ADX71149, a positive allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGluR2), is the result of a successful discovery collaboration and licensing deal announced in early 2005 between Addex and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI). Addex will receive a €2 million milestone payment from OMJPI.
"We believe that this mGluR2 PAM potentially offers one of the most exciting new and innovative ways to treat schizophrenia, anxiety and related indications," said Dr Vincent Mutel, CEO of Addex. "Our partner has expertise and an interest in this indication that are of great value to Addex. This collaboration - which already is profitable for our young company - illustrates the great potential of our strategy to capitalize on our allosteric modulator discovery platform via carefully selected development partnerships like this one."
The double-blind, placebo-controlled EU Phase IIa study will include about 105 schizophrenia patients in two parts:
Part A (monotherapy): 15 subjects with (sub)acute positive symptoms will be treated in an open-label design with a recommended starting dose of 50 mg bid. Then according to tolerability, as judged by the investigator, the dose may be increased stepwise to 100 mg bid up to the recommended target dose of 150 mg bid. In principle, the open-label treatment phase will last for maximally 12 weeks. Endpoints will examine tolerability, safety and efficacy.
Part B (add-on therapy): In 90 subjects with residual positive symptoms or predominant negative symptoms or in subjects with insufficient response to clozapine, ADX71149 will be administered in a double-blind, placebo-controlled, 2:1 (active drug : placebo) randomized design at 2 different dose levels, 50 mg bid up to maximally 150 mg bid, and this as adjunctive therapy to their currently prescribed antipsychotic. Endpoints will examine tolerability, safety and efficacy.
The development of ADX71149 is part of a worldwide research collaboration and license agreement between Addex and OMJPI to discover, develop and commercialize novel mGluR2 PAM for the treatment of anxiety, schizophrenia and undisclosed indications. Under the terms of the agreement, Addex is eligible for up to a total of €112 million in milestone payments upon potential development and regulatory achievements. In addition, Addex is eligible for low double-digit royalties on sales of mGluR2 PAM developed under the agreement.
Other news from the department research and development
Get the life science industry in your inbox
From now on, don't miss a thing: Our newsletter for biotechnology, pharma and life sciences brings you up to date every Tuesday and Thursday. The latest industry news, product highlights and innovations - compact and easy to understand in your inbox. Researched by us so you don't have to.
