Swiss biotech group Addex Pharmaceuticals announced that its lead drug candidate met expectations in a mid-stage clinical trial in heartburn, setting the company up for a lucrative partnership with a bigger drug maker that would provide much-needed funds for the startup company.
In a Phase IIb trial, Addex’s ADX10059 increased performed well in the treatment of gastroesophageal reflux disease (GERD). The four-week trial, which comprised 103 patients, showed ADX10059 significantly increased the number of symptom-free days for patients that took the drug compared to patients on a placebo. Patients involved in the trial had previously responded well to a group of drugs widely used for combating acid reflux called proton pump inhibitors, (PPIs).
The trial also showed that the medication was well tolerated among those in the trial. While adverse events were reported more often among those taking ADX10059 than the placebo group, the company reports that the vast majority of events were mild and none were described as severe. Participants who took ADX10059 also indicated a reduction in sleep disturbance compared to those in the placebo group, according to a patient questionnaire.
Addex says it has also completed patient recruitment for another trial of ADX10059, which combines the medication with PPIs. Results on that trial are expected in January 2010.
The results set Addex up to license the drug to a larger pharmaceutical company, which is anticipated sometime in 2010. Some estimates say a partnership could generate as much as $1.25 billion in annual sales.
Source: Addex Pharmaceuticals