Milan, Italy – October 2, 2007 - Newron Pharmaceuticals S.p.A. (“Newron”, SWX: NWRN), a research and development company focused on novel CNS and pain therapies, today announced the start of a phase II study with ralfinamide in post surgical (dental) pain.
The study, a phase II, pilot, randomised, placebo-controlled, double-blind, parallel-group, multi-centre study, is designed to determine the safety, tolerability and preliminary evidence of preventive analgesic efficacy of orally administered ralfinamide at a target dose of 480 mg/day, compared to placebo, in patients with third molar, post-extraction, dental pain. It is being conducted in India and Romania.
Approximately 180 patients (90 patients per group) will be randomised (1:1) to receive a maximum daily dose of 480 mg/day of ralfinamide or placebo. The patients will receive 5 days of pre-treatment with study medication prior to the day of the molar-extraction surgery, and will be treated on the day of surgery and for 2 days thereafter.
The trial follows a recently performed study which demonstrated that pre and/or post operative treatment with Ralfinamide provides long-lasting suppression of spontaneous post-surgical neuropathic pain-related behaviour, in a rat model of hindpaw neurectomy. It is believed that the analgesic and anti-inflammatory effects of ralfinamide are mediated through its modulation of ion channels implicated in pain, inhibition of substance P and glutamate release.
Ravi Anand, Newron’s CMO, commented: “The demonstration of analgesic and anti-inflammatory activity in this trial would indicate that ralfinamide could be developed for other post surgical pain and have potential for efficacy in other inflammatory pain conditions.”
About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. (www.newron.com) is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System, particularly Parkinson´s disease (PD), and pain. Newron is undertaking phase III trials with safinamide for the treatment of PD in conjunction with its partner, Merck Serono, which has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, Alzheimer´s disease, and other therapeutic applications. Safinamide is a unique molecule with a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent, reversible inhibition of MAO-B, and dopamine uptake) and reduction of glutamatergic activity by inhibiting glutamate release. Results of a six-month phase III trial of safinamide in PD as an add-on to dopamine agonist therapy demonstrated its benefit in motor symptoms and activities of daily living, as well as its improvement in cognitive function and good tolerability. Recent results of the 12-month extension of the trial showed that the addition of safinamide does not cause any tolerability/safety risk compared with dopamine agonist monotherapy and suggested that, at a dose of 50 to 100 mg once daily, safinamide may delay the time to intervention for therapeutic adjustment and provide sustained improvement of Parkinson’s disease symptoms when added to dopamine agonist therapy. Newron is conducting phase II trials with ralfinamide for the treatment of neuropathic and post dental extraction pain. A recently completed phase II placebo controlled study demonstrated the efficacy of ralfinamide in reducing neuropathic pain, as well as improving sleep and the ability to perform activities. The drug was well tolerated, with side effects comparable to placebo.
Newron´s clinical pipeline is supported by a portfolio of early-stage proprietary compounds generated by its ion channel drug discovery platform. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SWX Swiss Exchange, trading symbol NWRN.
For more information, contact:
Media nvestors and analysts Italy Luca Benatti - CEO Phone: +39 02 6103 4 626
UK/Global media Julia Phillips Financial Dynamics Phone: +44 (0) 20 7269 7187 Switzerland
Martin Meier-Pfister The Investor Relations Firm AG Phone: +41 43 244 81 40 Stefan Weber - CFO Phone: +39 02 6103 46 30
