Debiopharm Group (Debiopharm), and Pharmaleads SAS, a science driven drug discovery and early development company, announced the signature of an exclusive license agreement for the development, registration and commercialization of a small molecule called Debio 0827 or PL37, about to enter phase I clinical trials.
Debio 0827 is the first in a new class of painkillers that could be used in the treatment of chronic pain conditions, primarily in neuropathic pain. Under the terms of the agreement, Debiopharm will make an up-front payment to Pharmaleads, as well as further payments as Pharmaleads reaches predefined development milestones.
"With this agreement we add the new therapeutic area of chronic pain management to the Debiopharm product portfolio. There is currently an unmet medical need for the treatment of chronic pain, which can often not be treated successfully and can seriously affect patients' quality of life. For this reason, we have decided to develop this new therapeutic approach," said Rolland-Yves Mauvernay, President and Founder of Debiopharm Group.
"This exclusive licence agreement is very exciting and promising: it will speed up the development of a totally new class of painkillers, hence confirming the validity of our science and chemistry, as well as our capabilities as a drug discovery and early development company," added Thierry Bourbie, Chairman and CEO of Pharmaleads.
Following authorisation from the French Medicine Agency (AFSSAPS), Debio 0827 is about to enter a single ascending dose Phase I, randomised, double-blind, placebo controlled single oral dose escalation study in France, to investigate its safety, tolerability and pharmacokinetics in healthy volunteers.
Neuropathic pain is a major chronic pain condition. According to the most recent surveys, its estimated prevalence in the world's population is up to 6%, with many causes such as shingles, diabetes, antiviral or antitumor chemotherapy surgery, or low back disorders.