RGRN-305 is an orally administered new chemical entity in preparation for clinical phase 2b.
The company will now be able to develop, manufacture and commercialize the treatment for all human indications, including HS.
Under the agreement, Regranion will receive an upfront option payment with additional development and sales milestones as well as royalties, once MC2 Therapeutics exercises its option.
In addition, clinical data from a double-blinded placebo-controlled phase 2 trial in HS patients will be presented on October 11th during the upcoming European Academy of Dermatology and Venereology Congress in Berlin.
Jesper Lange, CEO of MC2, said: “This agreement is part of our strategy to leverage our scientific know-how to develop novel treatment paradigms within immune-mediated and inflammatory diseases where patients have no or limited treatment options.”
“RGRN-305 adds a third phase 2 stage project to our pipeline and holds the potential to become a leading oral drug for multiple large immune-mediated inflammatory diseases. Regranion has demonstrated an outstanding can-do attitude in the development of RGRN-305 – a mindset that we embrace at MC2. We look forward to building on the value already created.”
Gautam Ghatnekar, CEO of Regranion, added: “We are excited to partner RGRN-305 with MC2 Therapeutics which has a strong scientific and clinical expertise and a proven track record in clinical and regulatory development. We believe the compelling mode of action and the placebo controlled clinical trial data support the potential for RGRN-305 to become a leading oral drug for HS and other indications.”
Lars Iversen, CMO of MC2, also said that he was ‘encouraged’ by the positive biological effects that RGRN-305 demonstrated both in cell cultures and in clinical trials in humans.
“The project is a perfect match to the MC2 pipeline, and I am very pleased to be able to further explore the major potential of this compound,” he said.
