MedDay raises $38.5M to fund PhIII push for its multiple sclerosis drug

Eiffel Tower

MedDay has raised $38.5 million in a Series B funding round as it looks toward finishing up late-stage trials for its lead multiple sclerosis candidate--which the company is touting as a "breakthrough drug."

The French biotech told FierceBiotech the money was "additional security" and comes as it prepares to seek European approval for its multiple sclerosis drug candidate MD1003, while also helping MedDay to conduct a confirmatory Phase III study in the U.S. This builds on the $8.5 million it raised back in 2013.

Dr. Frédéric Sedel, MedDay's CEO, said that while there is a big and growing market for MS, MD1003 will not be entering into a crowded market as it targets progressive forms of MS, where no drugs are currently approved. Most new treatments are licensed for relapsing-remitting forms of the disease.

"The big players aren't providing drugs for this market [progressive forms of MS]--but it's not a small market; we think it makes up around half of all cases. So we are looking to move into a market with no rivals and utilize the drug's unique action that targets the nervous system, but not the immune system, as other treatments do.

"It can not only slow down inflammation but also reverse it in a significant number of patients--so I think it's a real breakthrough drug in this field."

The near-term focus will be on Europe and filing with the EMA, Sedel said, where the drug is currently being supplied by MedDay on a named patient basis to around 1,000 patients--something which is bringing in early revenue for the company, and what Sedel describes as a "validation of our approach with the drug."

He added that the company aims to file with the EMA "within the next month." The drug hit a setback last year after missing an endpoint in a Phase III vision loss trial. But the company did find efficacy in another arm of the study, leading it to re-focus on progressive forms of MS.

An IPO "would be the logical next step", Sedel said, and would help pay toward a future launch--but given the current environment for public offerings, which has seen a number of companies sell their shares at a much lower rate than they want, Sedel said he would wait until the headwinds died down before going public.

In terms of partnering, Sedel said the company is independent but adds that it is in discussions with other drugmakers about its lead candidate. "But as this time, I would say we don't need them. Once we have approval and need to sell the drug, we may look for a commercial partner to help us in certain regions; however I think we can move forward as a standalone company."

Data for the drug is based from a Phase III trial, which looked at 144 participants with primary or secondary progressive MS. The patients were split into two groups, receiving either 300 mg of MD1003 daily for 24 months or a placebo for a year, followed by 300 mg of MD1003 daily for 12 months.

Researchers were measuring whether participants had any improvement in disability at 9 months of treatment that was still apparent at 12 months. The trial data, released last April, showed 13% of the treatment group compared to none of the placebo group met this criteria demonstrating some improvement in the treatment group.

MedDay has also carried out a Phase III trial testing the effectiveness of MD1003 as a treatment for optic neuritis. In all, 93 participants with MS who experience optic neuritis (progressive and nonprogressive forms) were again split into two groups.

The aim was to test the effect of MD1003 on the clearness of vision and the thickness of the retina (the light sensitive nerve fiber layer at the back of the eye). The results did show that MD1003 had some improvement compared to placebo--but this was not significant, and the overall study did not show positive results.

The group that did see the most benefit were those with progressive forms of optic neuritis, and was why the company decided to refocus its future Phase III efforts confirming the drug's efficacy in patients with progressive forms of MS.

MedDay has also released a small, early-stage pilot study involving 23 participants with primary or secondary progressive MS that demonstrated that high doses of MD1003 may lead to improvements in disability.

This was an open-label study, in which patients were given 100-300 mg of MD1003 per day for 2-36 months. In total, 21 out of the 23 taking part showed evidence of some kind of improvement, including improved vision, cognition or walking.

Edmond de Rothschild Investment Partners (EDRIP) led the new investment round alongside existing investors Sofinnova Partners and InnoBio (Bpifrance). Large Venture (Bpifrance) also participated in the operation.

The company is also developing a number of other early-stage pipeline candidates as well as the advancement of a research platform aimed at identifying new metabolic targets in neurological diseases.

- check out the release