Marseille, France, 2009 November 10 - Trophos SA, a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology, announced today that olesoxime, its lead compound, currently in an ongoing pivotal efficacy study in Amyotrophic Lateral Sclerosis (ALS), has been selected as one of the Top 10 most promising neuroscience drugs in development available for strategic partnering.
“We are honoured that the olesoxime has been recognised as one of the top 10 most innovative and exciting neuroscience opportunities” said Damian Marron, Chief Executive Officer of Trophos. “The selection follows the recent selection of olesoxime as one of the top 5 projects entering phase III by Thomson Reuters The Ones to Watch. This is further industry recognition of the strong potential of Trophos approach and of our efforts in the fight against ALS. We are heartened that the industry is increasingly recognising efforts with rarer diseases.”
Olesoxime was selected by an independent committee assembled by Windhover Information, a leading provider of business information products and services to senior executives in the pharmaceutical, biotechnology, and medical device industries. The selection committee included Marc Wortman, Ph.D., associated with Windhover’s In Vivo and Start Up publication and Dr. Harry Tracy, President of NeuroInvestment, a leading independent neuroscience analyst. “Selected companies have been screened using a strict set of judging criteria for the Top 10 award and represent what our committees considered the most attractive neuroscience opportunities the industry has to offer,” said Roger Longman, Managing Director of Windhover Information. “Winners have met rigorous criteria including: unmet medical need, market potential, diversity of indications, strong science, multi-level partnering opportunities (biotech and pharma), potential for new opportunities beyond initial indications and corporate stability.”
As a selected company, Trophos will present olesoxime at Windhover’s Therapeutic Area Partnerships conference on November 18th in Boston.
The olesoxime ongoing pivotal efficacy study in ALS is a multicentre, European trial supported by the EU MitoTarget project (see below). The trial protocol has benefited from EMEA Protocol Advice procedure. Efficacy results are expected in mid-2011 (see press release of 5th May 2009).
Olesoxime (TRO19622) is the lead compound of the Trophos’ proprietary cholesterol-oxime compound family of mitochondrial pore modulators. Preclinical studies have demonstrated that the compounds promote the function and survival of neurons and other cell types under disease-relevant stress conditions through interactions with the mitochondrial permeability transition pore (mPTP) and olesoxime has been shown to be active in the SOD1 model of ALS (Bordet et al., JPET 322:709-720, 2007).
Olesoxime has successfully completed phase I studies in healthy volunteers and phase Ib studies in ALS patients. These clinical trials demonstrated that the product is well-tolerated and has an excellent safety profile. They also showed that once-a-day oral dosing achieves the predicted exposure level required for efficacy, based on preclinical models. Drug interaction studies with riluzole, the only registered treatment for ALS, showed no interaction of TRO19622 on riluzole pharmacokinetics.
The ongoing clinical study of olesoxime is part of a three year collaborative project named MitoTarget. The European Commission has awarded a grant of nearly EUR 6 million for MitoTarget which will be carried out by a consortium led by Trophos. MitoTarget forms part of the Seventh Framework Programme of the European Community for Research, Technological Development and Demonstration Activities. As well as the clinical trial, MitoTarget aims to enlarge the understanding of mitochondrial dysfunction in neurodegenerative diseases and assess the therapeutic potential of Trophos’ novel proprietary class of mitochondrial pore modulator molecules in neurological diseases (see press release of 18 December, 2008).
About ALS (Amyotrophic Lateral Sclerosis):
ALS, more commonly known as Lou Gehrig’s disease in the USA, is a progressive and fatal neurological disease that is estimated to affect over 100,000 people worldwide. There is no cure for ALS. The only drug approved for ALS is riluzole (Sanofi-Aventis), which has been demonstrated to give a 2-3 month survival benefit to ALS patients. For more information about ALS, see http://www.alsa.org
About Trophos: http://www.trophos.com
Trophos is a clinical stage pharmaceutical company developing innovative therapeutics from discovery to clinical validation for indications with under-served needs in neurology and cardiology. The Company has a novel and proprietary cholesterol-oxime based chemistry platform generating a pipeline of drug candidates, with the lead product, olesoxime (TRO19622), in phase II clinical trials and a second product, TRO40303, planned to enter the clinic in 2009. Trophos’ mitochondrial pore modulator compounds enhance the function and survival of stressed cells via modulation of dysfunctional mitochondria through interactions at the permeability transition pore (mPTP). Recently published clinical studies support the therapeutic rationale for mitochondria targeted drugs in neurology (Alzheimer’s disease) and cardiology (ischemia-reperfusion injury), which Trophos is uniquely placed to exploit.
