Akashi Therapeutics, Inc. a clinical stage biopharmaceutical company developing treatments for Duchenne muscular dystrophy (DMD), has announced a $100 million partnership with Grünenthal Group for a global drug development program for the investigational therapeutic HT-100, an orally available small molecule drug candidate in Phase 1b/2a for the reduction of fibrosis and inflammation, and promotion of healthy muscle fiber regeneration in DMD. HT-100 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
“This agreement represents a critical turning point for the company and offers powerful new hope for DMD patients and their families,” said Marc Blaustein, CEO of Akashi Therapeutics, a company that to date has been funded entirely by DMD patient foundations. “We are thrilled to find a partner who shares our commitment to this patient community, and look forward to accessing Grünenthal’s world-class scientific, clinical, regulatory and commercial capabilities to accelerate development and broad global availability of HT-100.”
Under the terms of the agreement, Grünenthal will make upfront and milestone payments to Akashi. In addition, the company will assume all post-Phase 2 global development costs through commercialization of an approved product. Grünenthal gains commercialization rights in Europe and Latin America, while Akashi retains rights for the U.S. and other markets. Akashi will receive royalties on net sales. In total, Grünenthal plans to commit more than $100 million to the partnership and will receive royalties on U.S. net sales in exchange for funding development of Akashi’s U.S. commercial infrastructure.
“We are very excited about this unique collaboration with Akashi. At Grünenthal, we are highly committed to innovation and have been focusing on bringing innovative therapies to patients with high medical need. We are very motivated to use all our strength for the development of HT-100 together with our partners from Akashi and the patient groups supporting them,” said Dr. Klaus-Dieter Langner, Chief Scientific Officer of Grünenthal.
The agreement also lays the groundwork to expand the collaboration to include Akashi’s other pipeline compounds for DMD and to explore additional indications for HT-100, which may also have activity in other fibrotic diseases such as scleroderma and idiopathic pulmonary fibrosis.