In addition, patients had significant quality of life improvements, with less fatigue, anxiety, irritability, affective lability, disturbance to waking, daytime drowsiness, headache, and nocturnal sleep.

NA-831 was well-tolerated with no adverse events or concerning safety signals. In addition, there was a significant improvement in the memory test performance for the Alzheimer’s patients in the study who were administered NA-831 compared to placebo.

NA-831 showed a significant improvement for patients with mild and moderate AD with the ADAS-Cog score changed of an average of 4.1 as compared to the placebo after 24 weeks of treatment . The Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus) showed 82.1% patients improved.
The topline results of the Phase 2A of NA-831 was presented at the Alzheimer Association International Conference (AAIC) - July 25, 2018 in Chicago and the follow-up results were given at the AAIC, July 17, 2019 in Los Angeles.

UPCOMING PHASE 3 CLINICAL TRIALS OF NA-831

Neuroactiva plans to conduct two Phase 3 programs for NA-831:

(1) The COGNITION Program for the treatment of 375 patients with mild and moderate Alzheimer’s disease over 12 months. Age group: 65- 80 years of age.

(2) The PREVENTION Program for the prevention of 550 subjects, asymptomatic from a high risk population over 24 months. Age group: 45-70 years of age.

These trials follow strict scientific standards and regulatory requirements to protect patients and help produce reliable results.

Study physicians will review risks and potential benefits with patients and their caregivers before patients are enrolled in the clinical trials.

The Phase 3 clinical trials of NA-831 have been designed to evaluate its safety and efficacy as required by the US Food and Drug Administration (FDA) and other regulators overseas before being approved for usage and marketing worldwide.

UPCOMING FOR CLINICAL TRIALS OF DRUGS FOR COVID-19

Biomed Industries, Inc. is conducting the following clinical trials:

BIOCOVAX™

Phase 3 Clinical Trials of BioCovax™ for the prophylaxis and treatment of Covid-19

A Phase 3, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Polio Vaccine and NA-831 for prophylaxis and treatment of early onset of Covid-19

In the Phase 3 clinical trial we will study the safety and efficacy of oral polio vaccine with and without NA-831 versus placebo, with 3,600 participants in many centers in the US, Canada, UK, Australia, New Zealand, China, Vietnam, and Brazil.

BIOMEDIVIR™

Phase 3 Clinical Trials of Biomedivir™ for the prophylaxis and treatment of Covid-19

Biomed has developed Biomedivir™, which is comprised of our neuroprotective agent called NA-831 and Atazanavir. Atazanavir was approved by the FDA for prevention and treatment of HIV/AIDS treatment, and is now a generic drug. Biomedivir™ is an oral formulation which can be used as a prophylaxis and treatment of early onset of Covid-19.

Biomed plans to launch the Phase 2/3 trials of Biomedivir™ for the prophylaxis and treatment of early onset of Covid-19 in early autumn 2020.

NANOMEDIVIR™

Biomed has developed Nanomedivir™, which is comprised of NA-831 and an anti-viral, Remdesivir (made by Gilead Sciences) in nanoparticle-based intranasal formulation. Remdesivir has been granted by the FDA for emergency use of severe cases of Covid-19.

Biomed plan to launch the Phase 1/2 clinical trials of Nanomedivir™ for the prophylaxis and treatment for early and moderate cases of Covid-19 in autumn 2020.

DEXANEUROSONE™

In addition, Biomed has also developed Dexaneurosone™, which is comprised of NA-831 and Dexamethasone in both oral and intranasal formulation. Dexamethasone is an FDA anti-inflammatory drug has been on the market for some 60 years and is used to treat conditions including arthritis and severe asthma. Recent finding that dexamethasone has life-saving potential for severe cases of Covid-19. Our animal studies indicated that a combination of Dexamethasone and NA-831 could be used to prevent and treat early and moderate cases of Covid-19.

Biomed plan to launch the Phase 2/3 clinical trials of Dexaneurosone™ for the prophylaxis and treatment for early and moderate cases of Covid-19 in autumn 2020.

Please contact us for study locations near you. Contact information is provided so you can reach out to them to find out more and schedule a visit.

More sites are being added regularly. For sites that are not yet recruiting, you can check back here or sign up for updates.

If you would like to be notified when a Alzheimer center near you is starting to enroll patients in the COGNITION Treatment or PREVENTION Study, please complete the contact form.