HE3286

BioVie Initiates Phase 2 Trial of Bezisterim for Long COVID Neurological Symptoms

7 days ago

• BioVie has enrolled the first patient in its Phase 2 ADDRESS-LC trial evaluating bezisterim for neurological symptoms of long COVID, with topline data expected in the first half of 2026. • Long COVID affects approximately 20 million adults in the US alone, with 10-30% of COVID-19 patients experiencing persistent symptoms including fatigue and cognitive impairment, yet no FDA-approved treatments exist. • Bezisterim targets neuroinflammation by modulating NF-κB activation and TNF-α production, pathways implicated in both long COVID and neurodegenerative diseases like Alzheimer's and Parkinson's.

BioVie Launches SUNRISE-PD Trial to Test Novel Anti-inflammatory Approach for Early Parkinson's Disease

a month ago

• BioVie has enrolled the first patient in its Phase 2 SUNRISE-PD trial evaluating bezisterim, an anti-inflammatory and insulin-sensitizing drug candidate, in early-stage Parkinson's disease patients who haven't received carbidopa/levodopa treatment. • The innovative trial features a hybrid decentralized design allowing patients to participate remotely from home, with support from major foundations including The Michael J. Fox Foundation, potentially expanding access to clinical research. • Bezisterim targets underlying inflammation and insulin resistance mechanisms implicated in Parkinson's disease progression, offering a potential alternative to traditional dopamine-replacement therapies that only provide symptomatic relief.

European Regulators Reject Eli Lilly's Alzheimer's Drug Kisunla Over Safety Concerns

2 months ago

• The European Medicines Agency's advisory committee has recommended against approving Eli Lilly's Alzheimer's treatment Kisunla, citing safety concerns related to brain swelling. • European regulators determined that the risks of amyloid-related imaging abnormalities (ARIA) outweigh the potential benefits of the drug, creating a notable divergence from US regulatory decisions. • This rejection marks another instance where European and American regulators have reached different conclusions on new Alzheimer's treatments, highlighting regional differences in benefit-risk assessment.

Alzheimer's Disease Pipeline Shows Promise with 120+ Therapies in Development

5 months ago

• Over 120 Alzheimer's Disease treatment therapies are under development by 110+ companies globally, ranging from preclinical to marketed phases. • Emerging therapies like NRDN-201, ST-501, and KarXT are in various clinical trial phases, showing potential for significant market impact. • MapLight Therapeutics initiated a Phase 1 trial for ML-007/PAC, targeting schizophrenia and Alzheimer's disease psychosis, with Phase 2 trials planned. • The FDA granted conventional approval to Leqembi (lecanemab-irmb), marking the first amyloid beta-directed antibody to transition from accelerated approval.

BioVie's Bezisterim to Enter Phase 2 Trial for Long COVID Treatment

6 months ago

• BioVie Inc. will present the design of its Phase 2 trial of bezisterim for Long COVID at the Demystifying Long COVID International Conference. • The Phase 2 study is a double-blind, randomized, placebo-controlled, multicenter trial involving approximately 200 patients. • Bezisterim's efficacy in reducing neurocognitive symptoms associated with Long COVID will be evaluated over a 3-month treatment period. • The trial is fully funded by a $13.1 million grant from the U.S. Department of Defense.

Parkinson's Disease Research Shifts Focus to Disease-Modifying Therapies

6 months ago

• Clinical research in Parkinson's disease (PD) is increasingly focused on disease-modifying therapies (DMTs) to address unmet needs beyond motor symptom management. • 66% of the 93 products in Phase I-III development target key mechanisms like alpha-synuclein aggregation and neuroinflammation to slow disease progression. • Late-stage DMTs include Annovis Bio’s Posiphen and BioVie’s Triolex, targeting alpha-synuclein inhibition and inflammatory mediators, respectively. • Research also emphasizes non-motor symptoms, with agents like Cerevance’s solengepras and IRLAB’s Pirepemat targeting postural instability and PD-dementia.

Parkinson's Disease Research Focuses on Disease-Modifying Therapies

6 months ago

• Clinical research in the seven major markets (7MM) for Parkinson's disease (PD) is heavily focused on disease-modifying therapies (DMTs) to address unmet needs. • 66% of the 93 products in Phase I-III development are prospective neuroprotective agents or DMTs targeting mechanisms like alpha-synuclein aggregation and neuroinflammation. • Researchers are also focusing on therapies for non-motor symptoms and postural instability, with 18% of the pipeline classified as 'other antiparkinsonian agents'.

Parkinson's Disease Research Focuses on Disease-Modifying Therapies

6 months ago

• The Parkinson's disease (PD) therapeutic market faces unmet needs, notably the absence of neuroprotective/disease-modifying therapies (DMTs) and treatments for non-motor symptoms. • A significant portion of the PD drug development pipeline is dedicated to neuroprotective and disease-modifying agents, targeting mechanisms like alpha-synuclein aggregation and neuroinflammation. • Clinical trials are underway for therapies addressing postural instability, PD-dementia, and cognitive/emotional impairments, reflecting a comprehensive approach to managing PD's complexities.

BioVie to Host Investor Webinar on November 7th, 2024, to Discuss Clinical Programs

7 months ago

• BioVie Inc. will host an investor webinar on November 7, 2024, to discuss its clinical programs in Parkinson's disease, long COVID, Alzheimer's disease, and ascites associated with advanced liver disease. • The webinar will feature Cuong Do, President and CEO of BioVie, who will provide insights on the company's mid-to-late-stage clinical programs. • BioVie's lead asset, bezisterim, has shown promise in modulating TNFα production and improving clinical outcomes in Parkinson's and Alzheimer's diseases. • The company plans to launch Phase 2b trials for Parkinson's disease and long COVID, and a Phase 3 trial for Alzheimer's disease, while also seeking partnerships for BIV201 in ascites.

BioVie's Bezisterim Receives Final Approval for Phase 2 Long COVID Trial

8 months ago

• BioVie Inc. has secured the final scientific approval from the U.S. Army for its Phase 2 trial evaluating bezisterim in treating neurological symptoms associated with long COVID. • The Phase 2 trial, expected to commence by early 2025, is a randomized, placebo-controlled study involving approximately 200 patients. • Bezisterim, an oral anti-inflammatory and insulin-sensitizing agent, targets chronic inflammation and blood-brain barrier dysfunction, key features of long COVID. • The trial is supported by a $12.6 million grant from the Department of Defense, adding to an initial $499,200 for the planning phase.

FDA Approves Digital Therapeutic for GAD, Updated Novavax COVID-19 Vaccine, and New Insulin Patch Pump

9 months ago

• The FDA cleared DaylightRX, the first digital therapeutic for generalized anxiety disorder (GAD), to be used as an adjunct to usual care for patients aged 22 years and older. • Novavax received emergency use authorization (EUA) from the FDA for its updated COVID-19 vaccine, NVX-CoV2705, for individuals aged 12 years and older. • Embecta gained FDA 510(k) clearance for its disposable insulin delivery system, designed for adults with type 1 and type 2 diabetes, featuring a 300-unit reservoir.

FDA Authorizes Phase 2 Trial of Bezisterim for Neurological Symptoms of Long COVID

9 months ago

• BioVie Inc. received FDA authorization for an Investigational New Drug application to study bezisterim (NE3107) in treating neurological symptoms associated with long COVID. • The Phase 2 trial will involve approximately 200 patients randomized to assess the safety and tolerability of bezisterim over three months, focusing on reducing neurocognitive symptoms. • Bezisterim, an orally bioavailable insulin sensitizer with anti-inflammatory properties, modulates NFkB activation, potentially addressing inflammation, a key driver of long COVID. • Current estimates suggest that 5.5% of US adults have long COVID, highlighting the urgent need for effective treatments, with bezisterim also under investigation for Alzheimer's and Parkinson's diseases.

Drug Development Updates