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NEWRON PHARMACEUTICALS S.P.A. Newron updates on STARS study FDA interaction

Directive transparence : information réglementée

11/03/2020 07:04

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study
Newron updates on STARS study FDA interaction

11.03.2020 / 07:04
The issuer is solely responsible for the content of this announcement.


Newron updates on STARS study FDA interaction

  • STARS (Sarizotan Treatment of Apneas in Rett Syndrome) clinical study to evaluate the effect of sarizotan in patients with Rett syndrome
  • Topline results from pivotal study on track for Q2 2020

Milan, Italy and Morristown, NJ, USA - March 11, 2020 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, announces that it has received the final minutes from a meeting with the U.S. Food and Drug Administration (FDA) held on February 5, 2020. In the meeting, the parties discussed the Company's statistical analysis plan (SAP), submitted to the FDA in September 2019, and the FDA's recommendations. The clinical database for the STARS study remains locked and blinded.

Ravi Anand, MD, Chief Medical Officer of Newron, stated: "We are pleased to report that Newron and the FDA have agreed on the SAP, the primary and key secondary efficacy measures, and the statistical analyses to be performed for efficacy. We are now finalizing the SAP and will submit it to the FDA in the coming weeks. Following the agency's review and approval of the plan, the contract research organization involved in the study will be able to complete its programming work and then move ahead towards unblinding of the results. We expect to be able to share the topline results of this important study with the global Rett community and the markets in Q2 2020."

About Rett Syndrome
Rett syndrome is a severe neurodevelopmental disorder primarily affecting females, with an estimated prevalence of one in 10,000 females. There are no approved treatments available. Rett syndrome is characterized by a loss of acquired fine and gross motor skills and the development of neurological, cognitive and autonomic dysfunction, which leads to loss of ability to conduct daily life activities, walk or communicate. Rett syndrome also is associated with a reduced life expectancy. Approximately 25 percent of the deaths in patients with Rett syndrome are possibly related to multiple cardio-respiratory dysrhythmias that result from brain stem immaturity and autonomic failure. More than 95 percent of these patients have a random mutation in the MeCP2 gene. Episodes of apnea, hyperventilation and disordered breathing are found in approximately 70 percent of patients with Rett syndrome at some stage of their life. For more information on Rett syndrome, visit http://www.rettsyndrome.org

About Sarizotan
Sarizotan, a new chemical entity licensed from Merck KGaA, is a highly selective compound for specific serotonin or dopamine receptors that modulates the activity of these neurotransmitters in the brain. As Sarizotan was originally developed in another indication, the compound was licensed with an extensive safety and tolerability data package. Sarizotan is being evaluated as a treatment for Rett syndrome, a debilitating genetic disorder with no specific treatment options, targeting respiratory disturbances. In preclinical evaluation studies, the full agonist at the serotonergic 5HT1A receptor has demonstrated dramatic improvement of respiration in a number of genetic mouse models of Rett.

About the STARS study
Newron Pharmaceutical's Sarizotan Treatment of Apneas in Rett Syndrome (STARS) is a clinical study to evaluate the efficacy, safety and tolerability of sarizotan in patients with Rett syndrome suffering from respiratory symptoms. Among the core symptoms of Rett, breathing disturbances may affect the whole person body; they can have a marked effect on biochemistry, influence emotions, circulation and digestive function as well as musculoskeletal structures in the respiratory process. The primary endpoint of the STARS study is the percentage reduction in these episodes of apnea during waking time compared with placebo.

About Newron Pharmaceuticals
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago(R)/safinamide has received marketing authorization for the treatment of Parkinson's disease in the European Union, Switzerland, the USA, Australia, Canada, Brazil, Colombia, the United Arab Emirates and Japan, and is commercialized by Newron's Partner Zambon. US WorldMeds holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. In addition to Xadago(R)/safinamide for Parkinson's disease, Newron has a strong pipeline of promising treatments for rare disease patients at various stages of clinical development, including sarizotan for patients with Rett syndrome and ralfinamide for patients with specific rare pain indications. Newron is also developing Evenamide as the potential first add-on therapy for the treatment of patients with positive symptoms of schizophrenia. For more information, please visit: www.newron.com


For more information, please contact

Newron
Stefan Weber - CEO
+39 02 6103 46 26
pr@newron.com

UK/Europe
Simon Conway / Natalie Garland-Collins, FTI Consulting
+44 20 3727 1000
SCnewron@fticonsulting.com

Switzerland
Martin Meier-Pfister, IRF
+41 43 244 81 40
meier-pfister@irf-reputation.ch

Germany/Europe
Anne Hennecke, MC Services
+49 211 52925222
anne.hennecke@mc-services.eu

USA
Paul Sagan, LaVoie Health Science
+1 617 374 8800, Ext. 112
psagan@lavoiehealthscience.com


Important Notices (update based on results)
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. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange, where the shares of Newron are listed. This announcement is not an offer for sale of securities in the United States, Canada, Australia or Japan or any other jurisdiction where such an offer or solicitation would otherwise be unlawful. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. Newron does not intend to register any of its securities in the United States or to conduct a public offering of its securities in the United States. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of this document shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.

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