EMERYVILLE, Calif., June 17, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the completion of its evaluation of ADS-5102 in multiple sclerosis patients with walking impairment (MSW).
A comprehensive analysis of the INROADS Phase 3 data validated the top line results announced in December 2019 and informed a revised target product profile reflecting the scale of clinical benefit observed in the study. Additional patient, physician, and payer research based on the revised profile projected a limited commercial opportunity. Further engagement with the U.S. Food and Drug Administration (FDA) to fully understand a potential path to submission confirmed the need for an additional pivotal Phase 3 confirmatory study. Based on these findings, Adamas reconfirms it will not initiate further Phase 3 development in MSW.
“As a patient focused company this was a difficult decision, and I want to thank the patients, healthcare professionals, and employees who contributed to this development program. There remains a significant unmet need for this population and we are committed to completing the open-label study and publishing our data to benefit the MS community,” said Neil F. McFarlane, CEO. “We remain focused on maximizing the opportunity for GOCOVRI to benefit Parkinson’s disease patients, which includes our recently filed sNDA for a label revision to include OFF episodes. Moving forward we believe we have sufficient capital to execute our near-term strategy and deliver long-term value for shareholders.”
GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension. For more information about GOCOVRI, please visit www.GOCOVRI.com.
Adamas evaluated 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®. 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 Expanded Disability Status Scale 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.
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.
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.
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.
At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to 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, including the expectations as to the long-term benefits of GOCOVRI, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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’ commercial activities relating to GOCOVRI, 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 May 7, 2020, 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.
Vice President of Corporate Communications
Managing Director, Westwicke