Evotec accelerates powerfully with positive phase II results for EVT 201 for insomnia
Evotec AG accelerated powerfully in October announcing positive results from its Phase II Trial of EVT 201, the acquisition Renovis, and a renewed focus on novel drug candidates to treat disorders of the central nervous system. Beyond proprietary programs, Evotec is actively seeking partners for contract research with an emphasis on opportunities for its fragment-based drug discovery platform.
In business development news, Evotec said the sale of its Chemical Development Business last month to Aptuit for GBP 31.5 million (EUR 45 million) will allow it to step up its effort to build a sustainable pipeline of novel drug candidates to treat disorders of the central nervous system (CNS).
The focus of the research is on identifying novel treatments for major CNS-related conditions including sleep disorders and Alzheimer’s disease and pain, fast growing therapeutic areas with large unmet medical needs.
Through in-licensing and the use of its platform for internal discovery efforts, Evotec is developing a preclinical and clinical CNS pipeline for partnering with pharmaceutical partners.
EVT 101, a highly potent and selective antagonist of NR2B subunit containing N-methyl-D-aspartic acid (NMDA) receptors with a potential in the treatment of Alzheimer’s disease and neuropathic pain, has completed Phase I trials successfully. Phase II programme planning is underway. A follow on, EVT 103, an NMDA NR2B subtype antagonist, is in preclinical development.
EVT 302, an orally active, potent, highly selective and reversible inhibitor of MAO-B in development for smoking cessation, is undergoing further phase I study.
EVT 102, an intravenous NR2B selective NMDA antagonists for post-operative pain, is in late preclinical development.
For its most advanced candidate, EVT 201, a partial positive allosteric modulator of the GABAA receptor complex, Evotec announced in October positive top-line results from its second phase II trial of EVT 201 in elderly primary insomnia patients with daytime sleepiness.
These top-line results are from the pre-specified intention-to-treat analysis from the 149 patients who were randomized into the study.
This U.S.-based, multi-centre, randomized, double-blind, placebo-controlled, parallel group design trial was designed to evaluate the hypnotic efficacy of EVT 201 in the treatment of primary insomnia in elderly patients with daytime sleepiness.
The PSG analysis also showed that EVT 201 generally preserved sleep architecture and EVT 201 was well tolerated. No serious treatment emergent adverse events were reported during the study.
“We’re delighted that these results in elderly insomniacs again confirm the excellent profile of EVT 201 as a potential treatment that helps patients to fall asleep quickly, maintains their sleep throughout the night and yet enables them to wake in the morning without hangover effects and feeling like they’ve had a good night’s sleep,” said Dr John Kemp, Chief Research & Development Officer, Evotec AG.
Jörn Aldag, President and Chief Executive Officer, Evotec AG, said: “The positive outcome of this second clinical Phase II trial with EVT 201 is particularly encouraging as elderly patients are particularly underserved by current treatments. The study’s confirmation of our earlier Phase II data in adults underscores the finding that EVT 201 has hypnotic efficacy in both adults and elderly primary insomniacs and we believe that these data make EVT 201 an extremely attractive partnering opportunity.”
Principal Investigator Dr James Walsh, Executive Director of the Sleep Medicine and Research Center, St John’s Mercy Medical Center, Chesterfield, Missouri, US, said: “In this second Phase II study with EVT 201 the robust efficacy seen previously in the adult population was duplicated with the same doses in elderly insomnia patients. It is exciting that the sleep-promoting effects seen throughout the night, coupled with no significant sedative activity of the drug during the daytime, allowed the improvement of sleep to be accompanied by significantly improved alertness during the day. This combination gives the compound a very attractive profile as a sleep promoting agent which improves both night-time and daytime symptoms of insomnia in the elderly.”
In late September 2007 Evotec AG and Renovis, Inc. announced they have entered into a definitive agreement under which Evotec will acquire Renovis, a biopharmaceutical company focused on the discovery and development of drugs for major medical needs in the areas of pain and inflammatory diseases, in a stock-for-stock transaction valued at approximately US $ 151.8 million
The acquisition of Renovis, based in South San Francisco, California, boosts Evotec’s pipeline with five compounds that complement Evotec’s program, including three clinical candidates and a strong late stage preclinical pipeline focusing on areas of neurological and inflammatory diseases.
Acquisition of the Renovis’ VR1 antagonists, a lead preclinical program in collaboration with Pfizer Inc., makes Evotec eligible to receive milestone payments of more than US$ 170 million and double-digit royalties on worldwide net sales of products successfully developed and commercialized.
“By combining Evotec’s drug discovery and development know-how with Renovis’ medicinal chemistry and target validation expertise, we expect to form a global biopharmaceutical company with world-class discovery capabilities,” said Evotec Chief Executive Jorn Aldag.
Evotec says it will seek a NASDAQ listing for the merged operation, which should help it buy out more drug developers.
A leader in the discovery and development of novel small molecule drugs, Evotec has established itself as the partner of choice in contract research for pharmaceutical and biotechnology companies worldwide. The Company provides innovative and often integrated solutions through a range of capabilities from early stage assay development and screening through to medicinal chemistry and drug manufacturing.
In collaborative research, Evotec applies a proven expertise in close collaboration with customers to deliver high level research and can quote outstanding references with the names of the world’s leading pharmaceutical and biotechnology companies appearing among its many partners.
To fully exploit the potential of its capabilities, Evotec looks to complement its traditional fee-for-service business with higher value, results-driven projects in core areas by sharing in the customer’s risk and success through significant milestone payments and royalties. In core areas of differentiation, Evotec has implemented Innovation Centers designed to deliver innovative solutions to the Pharmaceutical industry.
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