Adamas Announces Top-Line Results from INROADS Phase 3 Trial of ADS-5102 for Multiple Sclerosis Patients with Walking Impairment
– INROADS study achieved its primary endpoint (proportion of responders with at least a 20% improvement from baseline to Week 12) –
– Dose-response observed for both efficacy and safety –
– Safety data consistent with known safety profile of amantadine –
EMERYVILLE, Calif., Dec. 17, 2019 (GLOBE NEWSWIRE) — 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.”
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.
The INROADS study was a 12-week, three-arm, multi-center, randomized, double-blind, placebo-controlled study with a 4-week placebo-run in designed to evaluate the efficacy and safety of ADS-5102 for the treatment of walking impairment in multiple sclerosis. The study enrolled 594 patients with walking impairment in the US and Canada and randomized 560 patients in a 1:1:1 fashion to receive 274 mg ADS-5102 (N=185), 137 mg ADS-5102 (N=187), or placebo (N=186). The primary endpoint was the proportion of responders (at least 20% improvement in Timed 25-Foot Walk from baseline) at Week 12.
Key secondary endpoints include the mean change in the Timed 25-Foot Walk, the Timed Up and Go, and the 2-Minute Walk at 12-week post-treatment at both the 274 mg and 137 mg dose.
Baseline characteristics were similar across all treatment arms. The mean time since diagnosis of MS was 15.9 years, median EDSS at screening was 6.0, and mean timed 25-foot walk at baseline was between 11.5 to 12.4 seconds. Prior dalfampridine use was reported in 52.5% of patients and prior amantadine use was reported in 12.9% of patients.
About Walking Impairment in Multiple Sclerosis
Multiple sclerosis (MS) is a chronic neurological autoimmune disease that is often disabling with unpredictable symptoms. Among the MS patients in the US, nearly 270,000 have walking impairment, which is present throughout the day. Walking impairment in MS remains an area of high unmet need, as there is only one approved product on the market for this indication.
About Adamas Pharmaceuticals, Inc.
At Adamas, our purpose is clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company with a growing portfolio of therapies that address a range of neurological diseases. For more information, please visit www.adamaspharma.com.
Statements contained in this press release regarding matters that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this press release regarding Adamas’ development plans for ADS-5102, including its plan to fully assess its program in multiple sclerosis walking impairment and engage with the FDA on a potential regulatory pathway. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas’ research, clinical, development and commercial activities relating to GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, particularly under the caption “Risk Factors.” Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
Managing Director, Westwicke
Vice President of Corporate Communications