25 October 2016
Relief Therapeutics Holding AG (“Relief”, SIX: RLF), a biotechnology company dedicated to the clinical development of innovative molecules for the treatment of certain complications of Diabetes and of respiratory diseases, announces today, a strategic collaboration agreement between its subsidiary Relief Therapeutics SA and FirstString Research Inc. for the support of the clinical development in the United States of atexakin alfa, a low-dose formulation of recombinant human interleukin 6 (rhIL-6). Under the terms of this collaboration agreement, FirstString will seek US government financial support, develop relevant collaborations, and provide resources towards the Food and Drug Administration (FDA) requirements on the constitution of an Investigational New Drug (IND) application dossier for atexakin alfa in Diabetic Neuropathy. This collaboration is in line with the intention of both companies, operating in the area of diabetic complications, to develop a stronger research and commercial relationship.
Gaël Hédou, CEO of Relief Therapeutics SA declares: “We are delighted to take a concrete step toward an effective collaboration with FirstString. Not only will it allow us to progress atexakin alfa toward its clinical development in the US, but it anticipates our future company growth that is planned with FirstString”.
Gautam Ghatnekar, CEO of FirstString Research states: “We are excited to help advance the development of atexakin alfa in North America. Atexakin has shown tremendous potential to alleviate neuropathy, which would help diabetic patients in need of an efficient treatment. This collaboration with the Relief Therapeutics team constitutes a clear commitment on both sides to work on building a stronger strategic partnership”.
Atexakin alfa has originally been developed by Merck KGaA which licensed the worldwide rights to develop, manufacture and commercialize the compound to Relief Therapeutics in August 2015. Atexakin alfa has the potential to fulfill an unmet medical need in Diabetic Neuropathy by regenerating damaged nerve fibers, remyelination and reduction of neuropathic symptoms. Relief Therapeutics is currently designing and planning to test the compound in a phase II clinical trial to assess safety and efficacy as a disease modifier for Diabetic Neuropathy.
RELIEF THERAPEUTICS Holding AG is a clinical-stage biotechnology company with a portfolio of drug candidates derived from natural human origins. Its two most promising drug candidates are aviptadil for the treatment of sarcoidosis (already in Phase III) and low dose interleukin-6 (atexakin alfa) for the treatment of peripheral diabetic neuropathy (already in Phase II). Aviptadil development in sarcoidosis focuses the drug on an orphan disease market, in which European regulators have indicated that a single pivotal Phase III trial would be sufficient to support approval. Atexakin alfa is the subject of an exclusive worldwide development and commercialization agreement with a division of the global established pharmaceutical firm Merck KGaA and has been the subject of multiple clinical trials representing a major capital investment. Based on its unique mechanism of action, atexakin alfa could become the first regenerative therapeutic for peripheral neuropathy. The peripheral diabetic neuropathy market is estimated to reach $4.1 billion in 2019, according to Datamonitor.
RELIEF THERAPEUTICS Holding AG is listed on the SIX Swiss Exchange under the symbol RLF and is headquartered in Zurich, Switzerland.
For more information, please visit: www.relieftherapeutics.com
FirstString Research, Inc. is a privately held biopharmaceutical company located in Mt. Pleasant, South Carolina. FirstString is dedicated to delivering breakthrough solutions for inflammation-based medical conditions through an in-depth understanding of the molecular and cellular contexts that define the underlying pathology. The company’s lead product, Granexin® gel (aCT1), is a novel, proprietary peptide mimetic of the C-terminus of connexin43 that has shown to play a fundamental role in processes that are critical to inflammation and injury response. Granexin® gel has demonstrated statistically significant and clinically meaningful efficacy with good safety in one Phase 1 and three Phase 2 placebo-controlled, randomized, double-blinded clinical trials and is poised to enter Phase 3 development for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). Our clinical development strategies and product pipeline are based upon insights from biological context resulting in the validation of therapeutic potential for novel indications with earlier RoI prospects.
For more information, please visit: www.firststringresearch.com
RELIEF THERAPEUTICS Holding AG
Dr. Raghuram Selvaraju
Tel: +41 44 723 59 59
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA and other foreign review processes and other governmental regulation, RELIEF THERAPEUTICS Holding AG abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors. Relief Therapeutics undertakes no duty to update forward looking statements nor can be taken responsible in any manner if such statements are not verified in the future.