Addex Pharmaceuticals Announces ADX10061 Phase IIa SmokingCessation Data
May 1st, 2007 Posted by: Dr. Cox
GENEVA, Switzerland, Oct. 1, 2007-Allosteric modulation company Addex Pharmaceuticals Ltd announced today that ADX10061 did not meet the primary efficacy endpoint in a Phase IIa smoking cessation trial; it did not demonstrate a treatment effect compared to placebo.
The inlicensed competitive “orthosteric” dopamine D1 receptor antagonist is the only product in the Addex pipeline that is not an internally discovered allosteric modulator.
The double-blind, placebo-controlled U.S. study included 145 subjects in the intent to treat population. The primary endpoint was to assess whether ADX10061 increased the number of patients with four weeks continuous smoking abstinence starting from the beginning of week four of treatment. There was no separation of ADX10061 treated patients from placebo treated patients on the primary endpoint.
Similar trial designs and primary endpoints were used for buproprion and varenicline, both of which are marketed for smoking cessation. The study also was performed by key opinion leaders in the U.S. who were experienced with this standard study design for smoking cessation.
The major secondary efficacy endpoints did not reach significance. Development of ADX10061 for smoking cessation by Addex will not be continued. Addex may evaluate other opportunities for ADX10061 in the future but has no specific plans for the compound.
Conference call & webcast
Title: Addex Smoking Cessation Data
The webcast and slides will be available at: www.addexpharma.com
Teleconference for investors and analysts:
Date: 1 Oct 2007 Time: 17:00 ~ 18:00 CEST (11:00 ~ 12:00am EDT) Dial-in numbers: +41 91 610 56 00 (Europe) +44 207 107 0611 (UK) +1 866 291 4166 (USA)
A replay and transcript will be made available in the investor relations section of our website.
Pipeline review
Addex reported in April that in a French Phase IIa trial in 24 gastroesophageal reflux disease (GERD) patients, ADX10059, a negative allosteric modulator (NAM) of metabotropic glutamate receptor 5 (mGluR5), met the primary endpoint of 24-hour esophageal pH control that was significantly better than placebo. In the 2-day trial, patients received placebo on day 1 and either 50 mg or 250 mg of ADX10059 on day 2. Patients receiving 250 mg of ADX10059 had an esophageal pH