Actelion’s MS candidate shows promise
pharmafile | August 2, 2011 | News story | Research and Development | Actelion, MS
Actelion’s prospective multiple sclerosis pill ponesimod has cheered the company by meeting its primary endpoint in a phase IIb trial.
The selective S1P1 receptor agonist significantly reduced the number of new active inflammatory lesions in the brain in monthly scans from weeks 12 to 24 in patients with relapsing-remitting MS.
”This is the first report of a selective S1P1 receptor agonist reporting a statistically significant treatment effect in patients suffering from relapsing MS,” said Actelion chief scientific officer Martine Clozel.
Analyst Jefferies believes that both money and a relative inexperience in conducting big trials will lead Actelion to seek a partner to develop the drug, and expects an announcement on this in the next six to 12 months.
The phase IIb study looked at three ponesimod doses (10 mg, 20 mg or 40 mg) versus placebo, administered orally once daily for 24 weeks.
Average lymphocyte counts in patients were reduced in a “dose-dependent fashion”, returning to baseline values within a week in patients who stopped taking ponesimod.
“The relationship between lymphocyte count reduction and efficacy will be an important topic for further scientific scrutiny,” Clozel went on.
“The rapid reversibility of lymphocyte count observed upon treatment discontinuation already highlights a key differentiation attribute of this selective S1P1 receptor agonist and its pharmacokinetic profile,” she concluded.
The Swiss pharma firm says there was also a “clinically meaningful” effect observed on annualised relapse rate, which is an important secondary endpoint. No details of the phase III programme have yet been given.
The oral MS market is proving popular with pharma manufacturers at present, with Novartis’ Gilenya seeming to have a clear crack at it following the withdrawal of Merck KGaA’s rival Movectro from circulation.
“This S1P1 receptor agonist is theoretically a more selective drug than Novartis’ Gilenya,” points out Jefferies in a note to investors.
Sales of Teva’s patent-protected MS treatment Copaxone also rose 17% year on year to $3.3 billion in 2010.
Merck made its decision – a bitter disappointment to the German company – to pull all pending applications for its MS pill after regulators in the European Union and US demanded extensive new clinical trial data on the drug.
Adam Hill
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