EMERYVILLE, Calif., June 13, 2016 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today announced positive findings from its Phase 2 proof-of-concept study designed to evaluate ADS-5102 (amantadine HCl) extended-release capsules in individuals with multiple sclerosis (MS) who have impaired walking. Data from the study suggest that ADS-5102 is well tolerated in the MS patient population and has a significant positive impact on walking speed. The company plans to present these data at an upcoming scientific conference.
“We are excited by these positive MS walking data, which represent our fourth successful controlled clinical trial with ADS-5102,” stated Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “We are now ready to speak with the FDA about a pivotal registration program for impaired walking in people with MS. In addition, we also expect to submit our first NDA for ADS-5102 in 2016 for levodopa-induced dyskinesia associated with Parkinson’s disease. Over the next several months, we intend to analyze the best additional opportunities for ADS-5102 to create new therapies where no medicines exist or where improved treatment options are needed.”
Dr. Went continued, “We believe these novel data showing a benefit of ADS-5102 on walking speed in MS patients and the positive data generated in our Phase 3 trials for both dyskinesia and OFF time in Parkinson’s patients with dyskinesia further validate the strength of Adamas’ “shape matters” discovery and development platform. The notion of shape incorporates aspects like timing, the profile and drug level and how they can be modified to improve the way medicines behave in the body.”
Rajiv Patni, M.D., Chief Medical Officer of Adamas Pharmaceuticals, added, “We are extremely satisfied with the data as we believe it demonstrates the benefit ADS-5102 may be able to deliver to MS patients with walking impairment. Approximately 75 percent of individuals with MS experience clinically significant walking impairment; these are individuals who could potentially benefit from new medicines.”
Study Findings
The Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel group study evaluated ADS-5102 dosed at 340 mg once daily in an MS population for four weeks. Efficacy analyses were based on a modified intent-to-treat population (n=56). A key walking assessment was the timed 25-foot walk (T25FW) test, a well-established outcome measure. The T25FW test has previously been used as a basis for product approval in the United States and Europe. An approximately 15 percent placebo-adjusted improvement in walking speed was seen in the T25FW (p<0.05). The other walking performance measures used in this trial were directionally consistent. Further analyses are underway related to fatigue, depression and cognition.
The types of adverse events (AEs) reported with ADS-5102 in this study were consistent with the known safety profile of amantadine. The majority of study participants experienced at least one AE (17 patients in the ADS-5102 group and 19 patients in the placebo group). Of these patients, the recorded AE intensity was mild or moderate in the majority of patients (88 percent in the ADS-5102 group; 100 percent in the placebo group). Five patients discontinued study drug due to an AE; all of these patients were in the ADS-5102 group. Of these patients, one patient experienced a serious AE, which was deemed study drug related in the context of a multi-factorial clinical presentation. The most common AEs (occurring in at least two patients in the ADS-5102 group) were: dry mouth, constipation, insomnia, abnormal dreams, agitation, ataxia, dehydration, fall, hallucination, nausea, and pollakiuria (increased urinary frequency).
About the Trial
This 60 patient, Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel group study was designed to evaluate ADS-5102 dosed at 340 mg once daily at bedtime in an MS population with walking impairment for four weeks. In this proof-of-concept study, enrolled patients had impaired baseline walking speed. The primary outcome measure was the safety and tolerability of ADS-5102. Key secondary outcome measures included assessments of walking performance. Other outcome measures included assessments of other MS-related symptoms. Background MS medications were not to be changed during the course of the study.
About ADS-5102
Adamas' most advanced wholly-owned product candidate is ADS-5102 (amantadine HCl) extended-release capsules intended for once daily administration at bedtime. In PK studies, ADS-5102 has been shown to achieve high plasma amantadine concentrations in the early morning that are sustained throughout the afternoon and are lower in the evening. ADS-5102 is protected by a broad patent portfolio that provides coverage of multiple distinct features of ADS-5102, which contribute to its unique therapeutic profile.
About Adamas Pharmaceuticals
Adamas Pharmaceuticals, Inc. is driven to improve the lives of those affected by chronic disorders of the central nervous system. The company seeks to achieve this by modifying the pharmacokinetic profiles of approved drugs to create novel therapeutics for use alone and in fixed-dose combination products. Adamas is currently developing ADS-5102, its lead wholly-owned product candidate, for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease and for the treatment of major symptoms associated with multiple sclerosis in patients with walking impairment. The company is also evaluating ADS-4101, an extended-release version of an FDA-approved single-agent medicine for the treatment of epilepsy. In addition, under a license agreement with Forest Laboratories Holdings Limited, an indirect wholly-owned subsidiary of Allergan plc., the company is eligible to receive royalties from Forest on sales of Namenda XR® and Namzaric™ beginning in June of 2018 and May of 2020, respectively. For more information, please visit www.adamaspharma.com.
Namzaric™ is a trademark of Merz Pharma GmbH & Co. KGaA.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
Statements contained in this press release regarding matters that are not historical facts 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 conversations with the FDA about a registration program for ADS-5102 for walking impairment in MS, additional indications for ADS-5102, and that Adamas is on track to submit an NDA to the FDA later this year. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “look forward,” “on track,” “expect,” “potential,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to research, clinical and development activities of ADS-5102 and ADS-4101, the regulatory and competitive environment, as well as risks relating to Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2016. 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.