#ACTRIMS2018 – MS Therapy MD1003’s Disability Improvements Hold Over Time, Study Shows

MedDay Pharma’s MD1003 leads to long-lasting improvements in progressive multiple sclerosis patients’ disability, a Phase 3 clinical trial follow-up study shows.

Researchers presented the results at the third Annual Americas Committee for Treatment and Research in Multiple Sclerosis Forum in San Diego, Feb. 1-3. The poster presentation was titled “Effect of MD1003 (High-Dose Pharmaceutical Biotin) for the Treatment of Progressive MS: 36-Month Follow-up Data.”

The MS-SPI trial (NCT02220933) assessed MD1003’s ability to improve progressive MS patients’ disability, especially their walking problems. The San Diego presentation focused on the results of a 27-month follow-up to the nine-month trial.

In the trial, researchers randomized patients to received either MD1003 or a placebo, with the treated group consisting of 103 people and the control group 51. After the nine months, 133 patients received MD1003 until month 36.

Researchers checked patients’ disability at the end of the first, second and third years of the study. Two of the yardsticks they used were improvements in patients’ scores on the Expanded Disability Status Scale, or EDSS, and in an exercise capacity test known as TW25, or the time it takes to walk 25 feet. Two other barometers were Clinician and Subject Global Impression scales, which track patient progress and treatment over time.

A key finding was that MD1003 led to significant improvements in patients’ EDSS and TW25 scores at nine months, compared with the placebo-treated patients. The treatment’s benefits held at 18 and 30 months, researchers said.

After the placebo group switched to MD1003 at nine months, researchers saw no differences in new EDSS results between the treated and control groups at months 24 and 36.

But the group that received MD1003 for the first nine months continued to have better cumulative scores than those who initially received a placebo, then switched to MD1003. This suggested “that earlier treatment leads to a lower disability” at month 36, researchers wrote.

Another finding was that at one year the patients who were initially treated with MD1003 performed better in the time to walk 25 feet test than the controls. This held during the follow-up period. In contrast, the performance of the group initially treated with a placebo worsened in the final year.

In addition, the Clinician and Subject Global Impression scale results were significantly better in the MD1003-treated group during the first year, but there was no difference after that.

Patients tolerated MD1003 well during the follow-up study, researchers said. Seventy-nine percent of the placebo group had experienced adverse effects at three years, versus 67 percent of the treated group.

Overall, the results suggested that the improvements seen in the group that was initially treated with MD1003 lasted over time. In addition, the findings suggested that patients who switched to MD1003 after a year on the placebo saw their disease progression slow — although the delay in the start of their treatment led to them having more disability over time.