IPMC-CNRS spin-off Theralpha receives major grant for pain drug development

Theralpha, a biopharmaceutical company based in Sophia  Antipolis and specialized in development of new therapies for pain announces today the launch of SubAlgic, a three years program for the preclinical and clinical development of its candidate drug THA903. SubAlgic Consortium includes Synprosis, an Aix en Provence based company specialist in peptide synthesis, formulation and optimization, the Institute of Molecular and Cellular Pharmacology (IPMC, Sophia Antipolis), a worldwide renowned center in neurosciences and the Clermont Ferrand Center of Clinical Investigation, a European leader in pain clinical trials. SubAlgic program is accredited by the Eurobiomed cluster as part of the 12th FUI (Fond Unique Interministeriel) and supported also by  Conseil Général 06, Région PACA, Communauté du Pays d'Aix en Provence, Clermont Communauté for a total of €2,55M.

The SubAlgic program aims to develop a new drug (THA903) which does not interact with opioid receptors and which can be administered sublingually for acute pain management, an important unmet medical need. THA903 is a small peptide composed of 11 natural amino acids derived from a toxin of king cobra venom (Ophiophagus hannah) that has already shown promising efficacy and tolerability in pre-clinical pain models through sublingual delivery. SubAlgic program includes pre-clinical development completion and a first in human clinical study. This should validate the use of a sublingual form of THA903, for the management of acute pain.

“We at Theralpha are extremely proud of obtaining this major grant allowing the development of our proprietary drug candidate THA903, with the collaborative support of key experts. So many pain patients are in need of new treatment options due to troublesome side effects of existing medicines” commented David Dellamonica, CEO of Theralpha. "All the tools and competencies are in place with our SubAlgic partners to assess the potential therapeutic benefit of THA903. This would not have been possible without the strong support of  Eurobiomed competitiveness clusters, which has contributed to the creation of an environment supporting innovation.” mentioned Jean Pierre Salles, CEO of Synprosis.

"The SubAlgic program is a sign of the vitality of the Eurobiomed cluster. It combines high quality partners around key themes at the heart of our main interests. We are delighted with this well-deserved success." adds Michel Kaczorek, PhD, Director of Projects at Eurobiomed, Competitiveness Cluster in South of France “The SubAlgic program, through the development of THA903 should allow the development of a powerful new therapeutic class. Moreover, THA903 is not an opiate derivative, whose problems of tolerance and side effects are well known, such as respiratory depression and opioid-induced bowel dysfonction. We will customize a specific model for THA903 (translational multiarray) to highlight the pharmacodynamic potential in the earliest Phase I studies of this new drug” comments, Professor Claude Dubray, MD, PhD, director of the CIC at Clermont Ferrand.

 Theralpha SAS is a product development-oriented company, focusing on preclinical and clinical development of new pain therapeutics. Theralpha’s drug candidates originate from worldwide exclusive licenses from IPMC (Institut de Pharmacologie Moleculaire, CNRS, Sophia Antipolis, France) based on research made by Professor Michel Lazdunski and his team who have pioneered the discovery  of  venom derived peptides that selectively inhibit Acid Sensing Ion Channels (ASICs) which are directly implicated in pain signal transmission. Theralpha  benefits  also of a worldwide license for an  analgesic venom derived peptide generated at Protherapeutics, a National University of Singapore (NUS) spin-off.

Acute pain is always generated by an excess of nociception (pain sensation) as well as additional emotional components. It has multiple consequences on behavior, motor and autonomic functioning, but also on the biological balance of the patient, particularly in moderate to severe pain. The management of pain is an ongoing concern in many diseases, and after many medical procedures. The global acute pain therapeutics market was valued at $10.3 billion in 2010. The current landscape consists of branded, generic and off-label drugs, most of them being opioid derivatives, which have considerable drawbacks relating troublesome sideeffects.