Biotech Italy: Newron advances robust portoflio of late stage CNS drugs
Focused on novel therapies for diseases of the Central Nervous System and pain, Newron Pharmaceuticals S.p.A. announced it has received approval to initiate its first phase IIb/III study of ralfinamide in patients with moderate neuropathic low back pain (NLBP).
A 12-week, randomized, double-blind, international (Europe and Asia), phase IIb/III trial, the study is one of the two potentially pivotal studies required for an approval in neuropathic low back pain, an indication with a prevalence of about eight percent of the population with no approved treatments currently available. Some 400 patients with chronic NLBP of at least moderate severity will be randomized to treatment with ralfinamide at a daily dose of 160 mg, 320 mg, or matched placebo.
The announcement follows on the heels of Newron reporting the results of its recently completed Phase II safety and tolerability study with HF0220 in patients with mild to moderate Alzheimer’s disease (AD). The results allow Newron Pharmaceuticals to take the first step in the systematic development of HF0220, expected to have synergistic effects in combination with currently marketed anti-dementia drugs based on unique neuroprotective and anti-inflammatory mechanism of action and safety profile in AD patients.
Newron is also currently undertaking phase III trials with safinamide for the treatment of Parkinson’s disease (PD) in conjunction with its partner, Merck Serono, which has exclusive worldwide rights to develop, manufacture and commercialize the compound in PD, AD, and other therapeutic applications.
Newron recently reported excellent results for its compound ralfinamide in patients with Nerve Compression and Entrapment conditions, of which neuropathic low back pain represents the most common indication. There are no approved drugs for NLBP. The company expects to commence a phase IIb/III in NLBP later in 2008.
Headquartered in Bresso, near Milan, Italy, Newron is listed at SIX Swiss Exchange, trading under the symbol NWRN and has operations in Basel, Switzerland and Bristol, England, as well as Bresso.
Newron seeks to build its portfolio of drug candidates by both in-house research as well as licensing-in and acquiring compounds focused on CNS disorders including pain, at various stages of development. The company holds five clinical stage compounds with eight clinical indications.
In May 2008, Newron acquired Hunter-Fleming, a private UK biopharmaceutical company developing new medicines to treat neurodegenerative and inflammatory disorders, which greatly expanded the company’s pipeline.
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