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news.Trophos, a clinical stage pharmaceutical company developing therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, has completed patient enrolment with over 500 patients recruited into the pivotal Phase 3 efficacy study of Olesoxime in amyotrophic lateral sclerosis (ALS).
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The Phase 3 study is an 18-month randomised, parallel group, double-blind, placebo controlled trial evaluating the efficacy and safety of Olesoxime against placebo in patients diagnosed with ALS between 6 and 36 months before enrolment who are already treated with riluzole.
In the trial, Olesoxime is dosed at 330mg once a day, oral capsules and riluzole is dosed in both arms at 50mg twice a day. The study is being undertaken in 15 centers in France, Germany, UK, Belgium and Spain.
The primary end-point of the study is the overall 18 month survival rate. Secondary end-points include the ALS Functional Rating Scale, time to assisted ventilation, vital capacity (a measure of respiratory function), Manual Muscular Testing and quality of life. Safety and tolerability is closely monitored and an independent Data Safety Monitoring Board is overseeing the trial.
Trophos said that the study is supported by the EU FP7 MitoTarget project. The trial protocol has benefited from EMEA Scientific Advice procedure. Efficacy results are expected in the 4th quarter of 2011.
Jean-Louis Abitbol, chief medical officer at Trophos, said: “The completion of recruitment of patients in this key clinical study is a great achievement and a major step in the development of olesoxime. Over 500 patients have been included in the study in only 9 months, which reflects the motivation and hard work of all involved and the commitment of the teams at the clinical sites.”
Damian Marron, CEO of Trophos, said: “ALS urgently requires new therapies that can prolong survival and improve the patient’s respiratory and muscular functions. We believe Olesoxime could be a valuable new medicine for the ALS community and we look forward with great anticipation to the results of the trial in the fourth quarter of 2011.”