BioWorld International Correspondent
Newron Pharmaceuticals SpA, an Italian CNS drug development firm, has embarked on a new investment round, seeking additional financing to enable it to fund a pivotal Phase III trial of its candidate drug for Parkinson's disease, safinamide, in the first quarter of next year.
Newron has raised close to €40 million since its formation in 1998 through a management buyout of what was then a Pharmacia & Upjohn central nervous system research center. It garnered some €25 million of the total in its last investment round. The upcoming round, CEO Luca Benatti told BioWorld International, "will be in the region of the last round, if not more." The Bresso-based firm still has a year of cash left, he said.
Newron also disclosed positive results from a preliminary analysis of data from a Phase II trial of safinamide in medically intractable epilepsy patients, paving the way for an extended Phase IIb clinical trial early next year.
The interim analysis involved data from 29 of the 48 patients involved in the study, all of whom had uncontrolled seizures despite being treated with up to three anti-epileptic drugs. The primary endpoint of the trial was tolerability and absence of drug-to-drug interactions. Both were attained in the interim analysis, while a positive efficacy trend also was detected, the company reported, with a dose-dependent "significant reduction in median seizure frequency."
Safinamide has multiple mechanisms of action, with effects on glutamate release, monoamine oxidase B and ion channel activity. In epilepsy, it acts by blocking sodium and N-type calcium channels, Benatti said. "These two mechanisms play the key role in the anti-epileptic property of the drug," he said.
The drug's ion channel blocking effect can also alleviate the toxicity associated with excessive calcium influx in the neurons of Parkinson's patients, while its inhibition of monoamine oxidase B offsets dopamine depletion as it blocks the enzyme's oxidative deamination of the neurotransmitter.
The company previously has stated that it aims to secure a single partner for safinamide, and discussions are ongoing, but these will not dictate its development plans. "We're not waiting for a partner to go forward," Benatti said. The trial most likely will take place in Europe, although he did not rule out clinical centers in other locations.
In addition to the upcoming private placement, Newron is also mulling a possible flotation. The IPO window in Europe may open in the second half of next year, Benatti said, following the wave of flotations on Nasdaq in recent months. "If so, we will look very carefully, and we will be ready," he said. And where would the company be most likely to float ? "If you think of Europe, I would say the most attractive [market] looks like Switzerland now," he said. "I think probably Actelion [Ltd., of Allschwil, Switzerland] is creating the difference in terms of perception." But Nasdaq remains the "priority" market, he said, and the company is willing to follow the route taken by several other Italian firms that have undergone mergers with U.S. companies. "If it's an opportunity to grow and get access to the real biotechnology market, why not?"