MedDay Raises $38.5M to Finance Phase 3 Trial Targeting Progressive MS

MedDay SAS recently announced that it has raised €34 million, about $38.5 million, in a Series B financing round. The money will enable the company to lead a confirmatory Phase 3 clinical trial, called SPI2, in the United States to assess its lead candidate, MD1003, as a treatment for progressive multiple sclerosis (MS).

MedDay concluded a successful Phase 3 study, MS-SPI,  in spinal progressive MS patients in 2015, conducted at sites across France.

“This series B round will support the international development of our lead candidate MD1003 … we believe MD1003 represents a very promising drug for patients with progressive MS,”Frédéric Sedel, MD, PhD, MedDay’s chief executive officer, said in a press release. “The SPI2 study is expected to confirm, in a large North American population, the results of our prior European MS-SPI study and will further advance MedDay in the field of progressive MS worldwide. We are pleased to welcome additional specialist investors to MedDay.”

The Series B investment round was led by the French firm Edmond de Rothschild Investment Partners (EDRIP), alongside existing investors Sofinonova Partners and InnoBio (Bpifrance), and Large Venture (Bpifrance). The financing round will also be used to advance pre-launch activities of MD1003 in Europe, to develop other pipeline drug candidates, and to advance a research platform to identify new metabolic targets in neurological diseases.

MD1003 is a highly dosed pharmaceutical grade biotin with demonstrated efficacy in progressive MS patients. According to the company, MD1003 works by potentially influencing two targets related to the progressive form of MS: activating acetyl-CoA carboxylases (ACC1 and ACC2), the rate-limiting enzymes in the synthesis of fatty acids required for myelin synthesis; and activating the Krebs cycle in demyelinated axons, so as to avoid the hypoxia-related axonal degeneration that is responsible for disease progression.

Results from two Phase 3 studies, MS-SPI and MS-ON (studying chronic visual loss related to optic neuritis in MS), showed MD1003 has the ability to reverse disease progression in a subset of patients, and to slow the overall disease’s progression rate.

“We are delighted to invest in MedDay at such an important time and to be able to provide funding alongside such strong and supportive current investors. MedDay has the potential to be a game-changing biotech company in the major area of progressive MS,” said Raphaël Wisniewski of  Edmond de Rothschild Investment Partners. “Due to the existing data and current use of MD1003, MedDay’s platform and pipeline opportunities and strength of the management team, we are highly confident that MedDay will create major value for patients worldwide.”

MedDay, based in France, is focused on developing drugs that target brain metabolism to treat diseases of the nervous system.