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Make Alzheimer’s a disease of the past

Alzheimer patient Brain Neurons Brain biochemicals Pipeline

 

CLINICAL TRIALS

Clinical Trials Are the Path to New Treatments

There is no-disease modifying drugs ever been approved for marketing in the United States and all major countries. Researchers continue to find new and better approaches for slowing the progression of Alzheimer’s disease.

NeuroActiva™ has developed a new platform of new drug candidates for treatment of Alzheimer’s and other neurological diseases with innovative mechanism of action. Our flagship drug is called Traneurocin™ or NA-831™

CLINICAL TRIALS of NA-831™

HOW DOES THE DRUG NA-831 ™WORK?

The drug NA-831™is a small molecule drug that can be administered orally. The drug is an endogenous compound i.e. it already exists in the human brain. Basically, the drug is very safe and has no toxicity, suitable for long term treatment and prevention purpose.

The drug NA-831 can easily crosses the blood brain barrier, so only a small dose of the drug is required to be effective. The drug shows the following properties:

  • * NA-831™ exhibits neuroprotection to protect the brain from further damages
  • * The drug exhibits strong neurogenesis, i.e. ability to generate new neurons
  • * It is an endogenous compound (already exists is in the brain)
  • * It has great bioavailability in the body
  • * It is very safe, with no toxicity observed
  • * NA-831™ has been shown to enhance the cognitive functions and improving short term and long term memory of patients in Phase 2A studies
  • * It is available in oral formulation: convenient for patient to take one capsule of 30 mg per day per day.
  • PROOF OF SAFETY AND EFFICACY OF NA-831™ in PHASE 2 CLINICAL

    NeuroActiva has conducted a Randomized Double-Blind Placebo-Controlled Phase 2A Clinical Trial of NA-831 in Patients with MCI and Mild and Moderate Alzheimer’s Disease on 32 patients with mild cognitive impairment and 24 patients with mild and moderate Alzheimer’s disease.

    Based on the Brief Cognitive Rating Scale (BCRS,) the effects of NA-831 were apparent after 14 weeks of treatment (p=0.01), with the significant improvement after 24 weeks in the following areas:

  • * Ability to concentrate
  • * Short term memory,
  • * Long term memory,
  • * Ability to self care,
  • * Orientation
  • * Cognitive functions.

    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:
    BIOMED-pipelines



    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.


  • Prophylaxis and treatment for Alzheimer's disease and Covid-19:

    • Alzheimer and Covid

      Covid-19 Neuro-invasion

      SARS-CoV-2 can directly invade the CNS. NeuroActiva has developed neuroprotective interventions during the severe acute respiratory syndrome, and provide appropriate rehabilitation measures afterwards.

    • NA-831 capsule

      NA-831 (Traneurocin)

      (NA-831™)(Traneurocin™) is a novel neuroprotective and neurogenesis drug for treatment of Alzheimer's disease which will be in Phase 3 in 2020-2021

    • combination drug

      NA-831™ Drug Therapy

      We have developed drug combination therapy known as Biomedivr™, Neuromedivir™, Dexaneurosone™ Neurosivir™ for the prophylaxis and treatment of Covid-19

    • MICROS Infusion System

      MICROS™ Infusion System

      The MICROS is a FDA approved controlled release infusion system for intravenous administration of injectable drugs, including NA-704 for treatment of neurological diseases.