Adamas (ADMS) phase 3 trial of ADS-5102 for MS patients with walking impairment met its primary endpoint, did not demonstrate significant effect on secondary walking measures

Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that INROADS, a 3-arm, randomized, double-blind, placebo-controlled study in 594 multiple sclerosis (MS) patients with walking impairment met its primary endpoint.

Results from the study showed that patients taking 274 mg ADS-5102 had a statistically significant improvement in response rate of 21.1% compared to 11.3% taking placebo (p=0.01). Response was defined as at least a 20% improvement in walking speed from baseline to 12 weeks post-treatment, as measured by the Timed 25 Foot Walk. Additionally, the response rate for patients taking a lower dose of 137 mg ADS-5102 was 17.6% (p=0.08). ADS-5102 did not demonstrate a significant effect on the secondary walking measures at either dose.

“We are pleased that ADS-5102 shows a potential benefit for MS patients with walking impairment, for whom there is a significant unmet medical need and limited treatment options,“ said Neil F. McFarlane, Chief Executive Officer of Adamas Pharmaceuticals, Inc. “However, as we did not see the scale of clinical benefit we had hoped for in this study we will fully assess the potential for ADS-5102 in MS patients before determining the extent of our continued investment in this program.”

The most common adverse events (occurring in greater than 5% of any ADS-5102 treatment group) were: peripheral edema, dry mouth, fall, constipation, UTI, and insomnia. 20.5% of patients discontinued study drug due to adverse events in the 274 mg group, compared to 6.4% in the 137 mg group, and 3.8% in the placebo group. The reported adverse events associated with ADS-5102 in this study were dose-dependent and consistent with the known safety profile of amantadine.

“We would like to extend our sincere thanks to everyone involved in this study including the patients, investigators, and coordinators,” said Rajiv Patni, M.D., Chief Medical Officer of Adamas Pharmaceuticals, Inc. “We will now complete our analyses of these data to fully characterize the efficacy and safety profile of ADS-5102 and the dose response seen in this study. Given these data, we will not initiate the originally planned replicate second Phase 3 placebo-controlled study. We are continuing the open-label extension study and will engage with the FDA to discuss a potential regulatory pathway.”

“Walking impairment negatively impacts many aspects of daily life for a large number of patients, and additional treatment options are needed,” said INROADS Steering Committee Chair, Jeffrey Cohen, M.D., Director of experimental therapeutics at the Mellen Center for Multiple Sclerosis at Cleveland Clinic and a paid consultant for Adamas. “This trial result is encouraging for the MS patient and physician community and we look forward to reviewing the full data set.”

About ADS-5102

Adamas is evaluating ADS-5102 in the INROADS Phase 3 clinical study for multiple sclerosis patients with walking impairment. ADS-5102 was previously approved by the FDA under the trade name GOCOVRI® (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy. GOCOVRI is not FDA-approved for the treatment of multiple sclerosis patients with walking impairment.

You May Also Be Interested In

• Hepion Pharmaceuticals (HEPA) Winds Down Activities in Phase 2b ‘ASCEND-NASH’ Trial
• TG Therapeutics (TGTX) Announces Additional Data Presentations for BRIUMVI in Multiple Sclerosis
• Progress Software Corporation (PRGS) Issues Statement on a Possible Offer for MariaDB