Addex Pharmaceuticals: Development of ADX10059 ended for long-term use
Addex Pharmaceuticals 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.
A rise in transaminases to >5x ULN is considered to be predictive of a potential for drug induced liver injury. As these significant elevations in ALT have been observed in all the dose groups, Addex considers that future development of ADX10059 for long term use appears unlikely. The company will evaluate potential development options based on the complete analysis of the data from study 205, a 4-week study in GERD patients, which will report top-line data in early January.
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.
No liver function abnormalities have been seen in any of the previously reported clinical trials, several of which explored higher doses, including the recently reported study ADX10059-204, a 2-week study of monotherapy in 103 GERD patients. Study 205 a 4-week study of ADX10059 as an add-on therapy to PPIs in GERD patients, is due to un-blind around the end of the year and data will be reported in January.
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