Addex Pharmaceuticals (SWISS: ADXN) announced that it has beyond all question to end prematurely the migraine prevention study 206.

Routine safety monitoring of blinded facts in study 206 has revealed an incidence of abnormalities of liver business tests that is higher than expected in this population. The abnormalities are perceptible from day 28 of dosing but the incidence and severity be in sight to increase progressively with increasing duration of participation in the study. Despite the incident that the treatment allocation remains blinded, Addex is of the impression that the risk to benefit profile of the drug observed in the study is not sufficiently suitable to justify continuation of the trial and is terminating the study in the superlatively good interests of patient safety. The full benefit risk profile of ADX10059 in this indication will be evaluated once the study has been unblinded and the whole of efficacy and safety data have been analyzed.

“No liver function abnormalities own 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 for the re~on that an add-on therapy to PPIs in GERD patients, is debt to un-blind around the end of the year. The facts from that study will also help in the determination of the overall close custody profile of the drug,” said Charlotte Keywood, chief medical officer.

“This is each unfortunate and unexpected development,” said Vincent Mutel, chief executive officer. “We are acting to rapidly understand the relationship of the liver function abnormalities to the usage and the implications for development of ADX10059 in migraine prevention and other indications.”

Study ADX10059-206 is a double-hidden, placebo-controlled, dose range finding, multi-center European Phase IIb distress in 240 patients who suffer from three or more migraine attacks by means of month. Following a one-month baseline period, patients take study medication despite 3 months. The primary endpoint compares migraine frequency and severity in the be unconsumed month of treatment with the baseline. The data are being un-blinded and desire be analyzed and any indications of efficacy will be reported in early January.

Study ADX10059-205 is a double-blind, placebo-controlled, multi-center U.S. and European Phase IIb experiment in 280 GERD patients who are partial responders to proton cross-question inhibitors (PPIs). In Study 205 ADX10059 is being used as some add-on therapy to the patients’ existing PPI treatment. There was a baseline mark evaluation period followed by four weeks of administration of twice-diurnal ADX10059 (50mg, 100mg or 150mg). The primary endpoint is patient reported token control compared to baseline. Data are expected to be communicated in seasonable January.

Study ADX10059-204 was a double-blind, placebo-controlled, multi-center European Phase IIb attempt in 103 GERD patients known to respond well to PPIs. There was a brace-week baseline symptom evaluation period followed by two weeks of the ministry of ADX10059 120 mg twice daily. ADX10059 achieved the co-original endpoints of patient reported symptom control compared to baseline and the personal estate of ADX10059 on lower esophageal sphincter (LES) function as well being of the kind which multiple secondary endpoints. There were no serious adverse events in the study and close custody monitoring parameters were within normal limits. Mild or moderate adverse events included dizziness, vertigo and sleep disturbance.

Migraine is a condition distinguished by recurrent episodes of a characteristic cephalalgy, which can be accompanied by a variety of other symptoms in the same state as nausea, and sensitivity to light and sound. The average migraine uncomplaining suffers 12 attacks a year. The International Headache Society estimates that in an opposite direction 25% of migraine patients have three or more attacks per month and could do a good turn from migraine prevention treatment. A migraine attack, which typically lasts end for end 24 hours but can range from 4-72 hours, has three separate phases: the prodrome phase, when an array of individual warning signs — like blurred appearance or tingling of the skin — may begin to appear; the headache phase; and the postdrome phase, when many patients report fatigue or other “hangover-like” symptoms. As migraine attacks are prolonged, great number patients and especially those with frequent attacks, lose a significant amount of work and family time to suffering caused by the complaint. Indeed, migraine is currently estimated to cost employers $13 billion by the year in lost productivity in the United States. Prevalence of migraine is estimated at 12% in the United States, in which place about 30 million people suffer from migraine.

GERD (gastroesophageal reflux illness) is a chronic condition caused by stomach contents flowing back into the esophagus on a regular basis. The underlying cause of this is each abnormally functioning lower esophageal sphincter (LES) muscle that allows stomach solid ~ to pass back into the esophagus too easily. GERD leads to disquieting symptoms like heartburn and can also damage the lining of the esophagus. It is a common disorder with prevalence at about 15% in the United States and between 10% and 25% in EU. Marketed GERD products work by reducing the acidness of the stomach contents but do nothing to reduce reflux events, with equal rea~n that in many patients symptoms of GERD persist.

ADX10059 is a metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM). Glutamate overstimulation is cogitation to contribute via different mechanisms to pathology in both migraine and GERD. ADX10059 has been shown in clinical studies to form symptoms of acute migraine and, separately, to reduce reflux and GERD symptoms.

Addex Pharmaceuticals discovers and develops allosteric modulators toward human health. Allosteric modulators are a different kind of orally to be availed of small molecule therapeutic agent, which we believe will offer a prompted by emulation advantage over classical drugs. Our lead allosteric modulator product, ADX10059, ~y mGluR5 negative allosteric modulator (NAM), has achieved clinical proof of general and is in Phase IIb testing for the treatment of GERD and, singly, migraine prevention. ADX48621, our next-stage mGluR5 NAM, has completed Phase I testing and behest enter Phase II for Parkinson’s disease levodopa-induced dyskinesia (PD-LID) in 2010.

Our products and technology before that time have proven their value through our relationships with four of the utmost degree 10 pharmaceutical companies in the world. Specifically, under an agreement by Ortho-McNeil-Janssen Inc., a Johnson & Johnson company, ADX71149, an mGluR2 overbearing allosteric modulator (PAM), is undergoing Phase I clinical testing and has possible for treatment of schizophrenia and anxiety. Under two separate agreements with Merck & Co., Inc., we are developing PAMs of mGluR4 and mGluR5 taken in the character of drugs to treat Parkinson’s disease and schizophrenia, respectively. In addition, SR-One, the corporate venture arm of GlaxoSmithKline, and Roche Venture Fund obtain made equity investments in Addex.

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Addex Pharmaceuticals