Relief Therapeutics, readying for a pivotal clinical trial of a sarcoidosis treatment, announced that it is acquiring FirstString Research in an all-stock transaction that will add an advanced clinical stage product, Granexin, a potential treatment for diabetic foot ulcers and venous leg ulcers, to its drug portfolio.
Relief will also acquire FirstString’s pipeline of products, based on the functions of connexin protein signaling, that are in preclinical and early clinical development stages.
“This transaction is aimed at transitioning FirstString Research into the public equities markets and forging a powerful combination with Relief Therapeutics Holding AG, where we see highly attractive synergies between the FirstString and RELIEF pipelines,” Gautam Ghatnekar, PhD, president and chief executive officer of FirstString Research, said in a press release. “Notably, the potential concomitant development of a novel approach to the treatment of diabetic foot ulcers, Granexin gel, and an innovative strategy for the treatment of peripheral neuropathies, including those seen in diabetic patients, could result in the comprehensive management of the most devastating co-morbidities due to diabetes.”
Once the transaction is complete, Relief is expected to start two Phase 3 studies: one for Granexin gel in patients with diabetic foot ulcers and venous led ulcers, and other for aviptadil as the treatment of sarcoidosis. Because sarcoidosis is a rare disease, a single pivotal Phase 3 study for aviptadil may be sufficient for the treatment to be approved by the European Commission.
The proposed Phase 3 program for Granexin has already been reviewed and approved by the U.S. Food and Drug Administration (FDA).
The company, headquartered in Zurich, expects to start enrolling patients for both trials next year, and to present topline data in 2018.
“The envisaged acquisition of FirstString Research brings a cost-effective, capital-efficient drug development operation under the aegis of RELIEF THERAPEUTICS … and significantly broadens our pipeline,” said Raghuram Selvaraju, PhD, the company’s chairman. “We look forward to advancing both Granexin gel … as well as aviptadil for treatment of sarcoidosis into pivotal Phase 3 testing within the coming months, and welcome the FirstString team into the RELIEF organization.”
Another drug candidate, atexakin alfa, a low dose interleukin-6, is also expected to enter Phase 2 clinical trial in patients with peripheral neuropathies in 2017.