BioWorld International Correspondent
Newron Pharmaceuticals SpA moved its lead compound, safinamide, into a pivotal Phase III trial involving 240 patients with Parkinson's disease.
CEO Luca Benatti told BioWorld International that the company is looking to launch the product in Europe and the U.S. in 2007. At present, the trial is being conducted at 31 centers located in Europe, Asia and South America.
"We might be expanding to U.S. centers later in the year," Benatti said. The company has opened an investigational new drug application with the FDA, he said, and will be meeting FDA officials shortly to update them on its U.S. clinical strategy.
The double-blind, placebo-controlled study will compare two dose ranges of safinamide - 50-100 mg/day and 150-200 mg/day - vs. placebo as an add-on therapy, administered to early stage Parkinson's patients in conjunction with dopamine agonist therapy. Trial participants who complete an initial 24-week treatment period will be eligible to enter a 12-month continuation study. That will measure time from baseline to intervention, defined as either an increase in dopamine agonist dose, addition of a second dopamine agonist or levodopa, or discontinuation of therapy due to lack of efficacy.
Safinamide, originally discovered by the former Pharmacia & Upjohn, now part of Pfizer Inc., of New York, has multiple mechanisms of action. In Parkinson's, Benatti said, it acts by inhibiting dopamine re-uptake, monoamine oxidase B (the enzyme that breaks down dopamine) and release of the neurotransmitter glutamate, which ultimately has a protective effect on dopaminergic neurons.
The compound also is undergoing a Phase II trial in epilepsy. The company has said it would seek a single partner in both indications.
"We have discussions ongoing with a lot of [potential] partners," Benatti said. "We are not in a rush to partner the drug. We have strong support from our investors." Bresso, Italy-based Newron also has previously outlined plans to seek a market listing before the year end. That now depends on the mood of the markets.
"If the market conditions are not good, we will postpone the process until next year," Benatti said.