A Phase III trial of MedDay's multiple sclerosis drug has missed its primary endpoint. The drug, which made headlines in April when it was shown to improve mobility, failed to outperform the placebo in terms of improving the vision of people with multiple sclerosis.MedDay CEO Frédéric Sedel
Paris, France-based MedDay trialled its patented formulation of biotin in more than 90 patients, one-third of whom had progressive worsening visual loss. The remaining 62 patients had permanent but nonprogressive visual loss. Participants who received MedDay's drug, MD1003, improved by a mean of three letters on the sort of chart used by opticians to gauge the need for eye glasses. The placebo arm improved by 1.8 letters, a result that meant the difference fell short of being statistically significant. MedDay found more encouraging data when it split the patient population, though.
The positive reading of the trial was obtained through a prospectively defined subgroup analysis. When patients with nonprogressive visual loss were excluded from the analysis, the trial achieved statistical significance. Among the progressive subset of clinical trial participants, the treatment arm still posted an improvement of three letters, but those who received the placebo fared far worse. The placebo arm posted a worsening of 1.5 letters, resulting in a statistically significant difference between the two groups in the trial.
Having salvaged a positive efficacy reading of the trial, MedDay CEO Frédéric Sedel thinks the path forward for MD1003 is a little clearer. "The MS-ON data provide a better view about the future positioning of MD1003," he said in a statement. "MedDay will now pursue the development and file MD1003 only in progressive forms of MS, where there is a particular need for a disease modifying therapy and no drug approved so far." The earlier Phase III trial, which linked MD1003 to improved mobility, featured multiple sclerosis patients with progressive lower limb spasticity.
MedDay designed the two trials to give it a data set that could support a regulatory filing in Europe and act as the basis for discussions with FDA. The results could also form the backbone of financing talks. MedDay raised €8 million ($8.5 million) in 2013. Last month the chief executive of one of its backers, Bpifrance, told The Independent next time MedDay raises cash it will have a valuation of north of $1 billion.
- read the release