06 October 2016
PX’Therapeutics, a subsidiary of the Aguettant group, a company that specializes in the customer-tailored development of recombinant proteins, and RELIEF THERAPEUTICS Holding AG (“Relief”, SIX : RLF), a biotechnology company dedicated to the clinical development of innovative molecules for the treatment of certain diabetes-related complications, respiratory disorders and rare diseases, have announced today a strategic collaboration agreement for the production of atexakin alfa, a low-dose formulation of the recombinant human protein interleukin-6.
This Medicinal Product Candidate (MPC) aims to fulfill an unmet medical need in peripheral diabetic neuropathy by regenerating damaged nerve fibers, stimulating remyelination and reducing neuropathic symptoms. No existing marketed therapies for peripheral neuropathy are able to regenerate damaged peripheral nerves. As such, therefore, atexakin alfa could become the first truly disease-modifying drug for this condition.
In this project, PX’Therapeutics will develop an optimized production process for recombinant interleukin 6, a 185-amino acids cytokine, in CHO cells. PX’Therapeutics will also produce, in accordance with current Good Manufacturing Practices (cGMP) guidelines, protein batches that will be used for clinical trials.
Gaël Hédou, COO of Relief, comments: “This collaboration is a key step in the advancement of the atexakin alfa project, and we are delighted to be able to rely on the expertise of PX’Therapeutics to complete the production necessary to implement our clinical trials”.
Claire Untereiner, COO of PX’Therapeutics adds: “We are looking forward to this new collaboration with the Relief team for the development of this promising molecule. Based on the low doses required, we hope to be able to support Relief very far in its development, maybe even all the way to market…”
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 and 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
Located in Grenoble, PX’Therapeutics (a subsidiary of the pharmaceutical group Aguettant) is a biotechnology company specializing in engineering, process development and bioproduction of recombinant proteins, including monoclonal antibodies. Since its incorporation in 2000, PX’Therapeutics has played a very active role in the optimization, development and production of target proteins or therapeutic candidates for public and private laboratories and biotechnology companies based in Europe and North America. For more information, please visit: www.px-therapeutics.com
Claire Untereiner, C.O.O.
RELIEF THERAPEUTICS Holding AG
Dr. Raghuram Selvaraju
Tel: +41 44 723 59 59
This communication expressly or implicitly contains certain forward-looking statements concerning Relief Therapeutics Holding AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Relief Therapeutics Holding AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Relief Therapeutics Holding AG is providing this communication as of this date and does not undertake to update any forward looking statements contained herein as a result of new information, future events or otherwise.