Newron reports SERENA trial top-line results for ralfinamide

Newron reports SERENA trial top-line results for ralfinamide

MILAN, Italy - Newron Pharmaceuticals S.p.A. ("Newron" SIX: NWRN), a research and development company focused on novel CNS and pain therapies, today announced top-line results of its SERENA study, a phase IIb/III study of ralfinamide in patients with at least moderate Neuropathic Low Back Pain (NLBP).

The 12-week SERENA study enrolled 411 patients with chronic NLBP of at least moderate severity and evaluated the safety and efficacy of two dose regimens of ralfinamide compared to placebo.

Available results on the primary endpoint of the study, the change from baseline for the 11-point Likert Scale, did not detect any significant difference between ralfinamide and placebo. Ralfinamide was well tolerated, with no clinically significant differences from placebo on safety measures.

Further analyses of the additional endpoints (VAS, PGI, CGI etc.)** are currently ongoing and will be reviewed with Newron's external advisors. Based on the multiple CNS effects seen in animal pharmacology models, and the excellent human safety data, Newron will decide how to proceed further with the compound.

Luca Benatti, Newron´s Chief Executive Officer, commented: "We are extremely surprised and disappointed by the results, based on the statistically significant benefits shown in a phase II placebo-controlled trial, as well as the results from a large number of preclinical studies. We shall be working with our external advisors to make a complete assessment of the data prior to determining our next steps, including a review of our development resource needs going forward. We have a broad portfolio of products in various stages of development, addressing substantial market opportunities and this, combined with our existing cash resources and SEDA equity line, gives Newron continued potential for growth and value generation".

In addition to ralfinamide, Newron has an advanced pipeline of innovative compounds, that include safinamide, currently in phase III development for the treatment of Parkinson's disease (add-on treatment for all stages of PD) together with Merck Serono; NW-3509, an novel treatment for schizophrenia expected to enter human trials later this year, and HF0220, a potential disease-modifying therapy for neurodegenerative disorders, currently in phase II.

* SERENA: Safety and Efficacy of Ralfinamide in nEuropathic low back paiN pAtients.
** VAS - Visual Analog Scale, PGI - Patient global impression of change, CGI - Clinical global impression of severity and change

About Newron Pharmaceuticals
Newron Pharmaceuticals S.p.A. ( is a biopharmaceutical company focused on novel therapies for diseases of the Central Nervous System and pain. Newron is 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, Alzheimer's disease, and other therapeutic applications. Newron's additional projects are in various stages of preclinical and clinical development, including NW-3509 for the treatment of schizophrenia and HF0220 for neuroprotection. Newron is headquartered in Bresso, near Milan, Italy. The company is listed at SIX Swiss Exchange, trading symbol NWRN.

For more information, contact:
Investors and analysts
Luca Benatti - CEO
Phone: +39 02 6103 4 626
E-mail: [email protected]
UK/Global media
Julia Phillips
Financial Dynamics
Phone: +44 (0) 20 7269 7187
Martin Meier-Pfister
IRF Communications
Phone: +41 43 244 81 40
Stefan Weber - CFO
Phone: +39 02 6103 46 30
E-mail: [email protected]

Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron's ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialisation of its product candidates and reduce costs (including staff costs), (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron's anticipated future revenues, capital expenditures and financial resources, and (4) assumptions underlying any such statements. In some cases these statements and assumptions can be identified by the fact that they use words such as "will", "anticipate", "estimate", "expect", "project", "intend", "plan", "believe", "target", and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements.

By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions.

Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programmes, development activities, commercialisation plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions.

Source: Newron