NeuroActiva, Inc. Announced Results from Phase 2A Clinical Trial of NA-831 in Patients with Mild Cognitive Impairment and Mild and Moderate Alzheimer’s Disease at the AAIC 2018 Conference in Chicago

  SAN JOSE, CA - 07/30/2018 (PRESS RELEASE JET)

NeuroActiva, Inc. (Headquarters: San Jose, California, USA, CEO: Lloyd L. Tran, “NeuroActiva”) announced results from a Phase IIA clinical study of the investigational oral NA-831 at the Alzheimer’s Association International Conference (AAIC) 2018 being held in Chicago, Illinois, United States, from July 22 to 26, 2018. This poster presentation was accepted as a Late Breaking Abstract for AAIC (Poster No. P4-201).

The study was a randomized, double-blind, placebo-controlled parallel-group 24-week Phase IIA clinical study of NA-831, conducted in patients with mild cognitive impairment (MCI), or patients with mild and moderate Alzheimer’s disease. In addition to the primary safety objective, the study assessed the efficacy in terms of clinical symptoms, which were exploratory objectives in this study.

Mild cognitive impairment (“MCI”) is defined as the “symptomatic pre-dementia stage” on the continuum of cognitive decline leading to Alzheimer’s disease. Currently, there are no disease-modifying approved therapies available for MCI and Alzheimer’s disease (AD). NA-831 is a small drug molecule that exhibits neuroprotection, neurogenesis, and cognitive protective properties across a range of disease models. NA-831 has been shown to be safe and well tolerated in healthy volunteers.

A randomized clinical trial of NA-831 was performed in 32 Alzheimer patients with MCI due to Alzheimer’s disease, and 24 patients with mild and moderate Alzheimer’s disease. The patients with MCI received 10 mg of NA-831 or placebo orally per day. The patients with mild and moderate Alzheimer’s disease received 30 mg of NA-831 or placebo orally per day.

Clinical efficacy was evaluated using the Brief Cognitive Rating Scale (BCRS), and the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-13 ). Based on the BCRS, the effects of NA-831 were apparent (p=0.001), with the significant improvement in the following areas: fatigue, anxiety, irritability, affective lability, disturbance to waking, daytime drowsiness, headache, and nocturnal sleep. After 24 weeks of treatment for patients with mild and moderate Alzheimer’s disease, NA-831 showed a significant improvement with the ADAS-Cog score change of an average of 4.1 as compared to the placebo (significant value P = 0.01; ITT). This represented a 47% slowing in rate of decline for the NA-831 arm which was considered to be clinically important.

NA-831 was well-tolerated at 30 mg per day administered orally. There were no serious adverse events observed, except 4 patients in the mild and moderate Alzheimer disease cohort reported having minor headaches and diarrhea.

While the study was not powered to show statistical significance compared to placebo on clinical symptoms, the results suggest that NA-831 could slow decline in cognitive function of patients with MCI due to Alzheimer’s disease, or mild to moderate dementia due to Alzheimer’s disease.

This press release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.

NeuroActiva Safe Harbor

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements about results from the Phase II study of NA-831; the potential clinical effects of NA-831; the potential benefits, safety, and efficacy of NA-831; the clinical development program for NA-831; risks and uncertainties associated with drug development and commercialization; the treatment of Alzheimer’s disease; NeuroActiva’s strategy and plans; and the potential of NeuroActiva’s commercial business and pipeline programs, including NA-831. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including, without limitation: the risk that clinical trials may not fully enroll or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis, or results obtained during clinical trials; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of NeuroActiva’s drug candidates, including NA-831 ; the occurrence of adverse safety events; NeuroActiva may encounter other unexpected hurdles; uncertainty of success in the development and potential commercialization of NA-831, which may be impacted by, among other things, unexpected concerns that may arise from additional data or analysis, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect and enforce NeuroActiva ’s data, intellectual property, and other proprietary rights and uncertainties relating to intellectual property claims and challenges. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from NeuroActiva’s expectations in any forward-looking statement. These statements are based on NeuroActiva’s current beliefs and expectations and speak only as of the date of this press release. NeuroActivadoes not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

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