Biogen Idec (NASDAQ: BIIB) and Vernalis plc (LSE: VER, Nasdaq: VNLS) announced the initiation of the Phase II program of BIIB014 (also known as V2006), an oral compound, for the treatment of Parkinson’s disease.
BIIB014 is an adenosine A2A receptor antagonist that may offer a non-dopaminergic therapy for patients with Parkinson’s disease.
The initial Phase II study is a double-blind, placebo controlled randomised trial of single and repeated doses of BIIB014 in patients with late-stage Parkinson’s disease. In the trial BIIB014 will be added on to the patients usual L-dopa therapy. The second Phase II study will be a double-blind, placebo controlled randomised, dose-ranging trial of BIIB014 monotherapy in patients with early-stage Parkinson’s disease. The primary endpoint of both studies will be to evaluate the safety and tolerability of BIIB014. Secondary endpoints will include the evaluation of motor function.
Simon Sturge, CEO of Vernalis commented:
“The progress into Phase II trials is of particular significance to Vernalis’ growing Parkinson’s disease franchise and further demonstrates the company’s ongoing commitment to the Parkinson’s community. Dopamine replacement therapy has been the cornerstone of Parkinson’s disease therapy, but there is a real need for a new class of non-dopaminergic agents which may help to restore motor function in Parkinson’s disease patients without inducing the adverse effects that limit the clinical utility of current therapies.”
“BIIB014 has the potential to be a novel, non-dopaminergic treatment option for people living with Parkinson’s disease. We are pleased with the advancement of this program, which is part of Biogen Idec’s effort to extend our research and development capabilities beyond multiple sclerosis and into other neurological diseases,” said Alfred Sandrock, MD, PhD, Senior Vice President, Neurology Research and Development, Biogen Idec.
Phase I development of BIIB014 was successfully completed by Vernalis, with Biogen Idec now responsible for conducting and funding future development. Vernalis received a milestone payment of $3 million at the end of 2006 relating to the start of the Phase II programme and will receive additional milestones and royalties on the successful development and commercialisation of products. In addition, Vernalis has an option to co-promote products arising out of this collaboration in the U.S.