Multiple Sclerosis Headliner, MedDay’s MD1003, has flopped in its phase III trial after failing to meet its primary endpoint. This is a disastrous blow for the supposedly vision-restoring drug, which was hoped to help aid patients with Multiple sclerosis experiencing vision loss.
This was tested by the Optometrist ‘Letter’ tool (a Snellen chart), which over the course of the MD1003 should have improved the number of letters being read from a distance. This would indicate a therapeutic effect against the inflammation caused by MS-Optical neuritis when compared to a placebo. However, at the end of the 90 patient trial, the MD1003 candidate fell short with results of improved visual acuity being statistically non-significant.
Although, the drug was shown to improve mobility…so perhaps not all is lost just yet. But as a whole, this latest phase III trial is a big setback for MedDay and its R&D of the MD1003 candidate.
A Second Victim to the Friday Doom…
Another depressing development in Biotech is the failure of the phase III diabetic foot ulcer drug by CytoTools. Darmstadt (Germany) based CytoTools stock was slashed up to 85% in a single trading session following the results announcement on Friday 27th (aka Black Friday – the irony…).
Employed into a 2-year long phase III trial spanning 7 countries, DermaPro was administered to over 305 diabetics with foot ulcers, the medicinal properties of which were tested against a saline placebo solution. Following 12 weeks of using the DermaPro/Saline treatment, sadly it was found that there was no significant difference in rate of blister healing..
This came as quite a shock to CytoTools (and shareholders alike) along with their India based counterpart, Centaur Pharmaceuticals, who had also conducted a phase III trial earlier this year for DermaPro with fantastic results (a ‘91% cure rate’!).
So why were the results so abysmal in the EU trial? CytoTools is just baffled by these figures though, speculating whether the trial length (of 12 weeks) or the inclusion/exclusion factor for the sizes of wounds were possible reasons for the diabolical results.
As its CMO, Markus Weissbach, put it:
Currently, it is inexplicable to us why the results are so much worse than that of previous studies”
Whaa…. Perhaps the situation is still salvageable…but it will be a long, tough and a critical crawl back to security for CytoTools, given their market cap has now settled to a rock-bottom €13M after this weekend. There are talks of a possible re-attempt at a phase III trial, but it appears investors have already jumped ship, and it could be a real struggle to get the DermaPro momentum going again.
Can either of these biotechs recover from these setbacks? MedDay, perhaps…but I’m not sure how easy it will be for CytoTools to get back on track.