Addex Pharma (ADDXF.PK) announced that based on preliminary review of the unblinded data from study 206, it has terminated development of ADX10059 for chronic indications, including long term treatment of gastroesophageal reflux disease and migraine prophylaxis.
In study 206 the incidence of alanine transaminase (ALT) levels greater than five times the upper limit of normal (>5xULN) levels was 6% (16 of 257 patients); however, bilirubin remained normal in all but one patient. The elevation of ALT occurred in all dose groups and appears to be related to the duration of dosing. The incidence was 3.9% (10 patients) in the 100 mg group; 0.8% (2 patients) in the 50 mg group; 1.6% (4 patients) in the 25 mg group. No abnormalities of liver function were observed in the placebo group.
Study 205 is still blinded however, a review of blinded safety data show an incidence of ALT >5x ULN of 0.6% (2 of 295 patients). This is in-line with expectations for this type of study.
"The occurrence of liver function abnormalities in patients receiving the lowest dose, makes future development of this compound difficult, especially for long term use," said Charlotte Keywood, chief medical officer.
"We have cash for operations until the end of 2011 and plan to focus our efforts on development of ADX48621, which has completed Phase I testing and is scheduled to start Phase II testing for the treatment of Parkinson's disease levodopa induced dyskinesia in the fourth quarter of 2010," said Vincent Mutel, chief executive officer.
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