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Clinical Trial News

Merck's Winrevair Shows Promise in Pulmonary Hypertension; Cassava's Alzheimer's Drug Fails Trial

• Merck's Winrevair significantly reduced the risk of death, lung transplantation, or disease-related hospitalizations in pulmonary arterial hypertension patients, meeting its Phase 3 trial endpoint. • Cassava Sciences' experimental treatment, sumifilam, failed to slow cognitive or functional decline in Alzheimer's patients compared to placebo in a Phase 3 study. • The FDA approved BridgeBio's Attruby for transthyretin amyloid cardiomyopathy (ATTR-CM), demonstrating a 42% reduction in mortality and cardiovascular hospitalizations. • Research indicates a potential link between Merck's asthma drug, Singulair, and severe mental health issues, reinforcing previous FDA warnings.

BioAdaptives' Zeranovia Receives IRB Approval for Human Clinical Trial in Weight Management

  • BioAdaptives Inc. has secured Institutional Review Board (IRB) approval to commence a human clinical trial for its weight management product, Zeranovia™.
  • The initial phase of the trial, to be conducted in Las Vegas, Nevada, will focus on confirming dosing and identifying potential side effects.
  • Zeranovia™ is a high-protein blend of vitamins, minerals, and five concentrated herbal supplements, including four adaptogens.
  • BioAdaptives aims to provide scientifically validated nutraceuticals, potentially offering a natural alternative to synthetic GLP-1 and GIP treatments.

BioAdaptives' Zeranovia Receives IRB Approval for Weight Management Clinical Trial

  • BioAdaptives Inc. has secured IRB approval to commence human clinical trials for Zeranovia, a weight management product, in Las Vegas, Nevada.
  • The initial phase of the trial will focus on confirming the appropriate dosage and monitoring for any potential side effects in participants.
  • Zeranovia is formulated with a high-protein blend, vitamins, minerals, and adaptogenic herbal supplements, aiming for results comparable to GLP-1 and GIP treatments.
  • BioAdaptives emphasizes its commitment to scientifically validated nutraceuticals, noting that less than 1% of such products undergo human clinical trials.

Cassava Sciences' Simufilam Fails Phase III Alzheimer's Trial, Stock Plummets

  • Cassava Sciences' Phase III trial of simufilam in mild-to-moderate Alzheimer's disease failed to meet primary endpoints, showing no significant reduction in cognitive decline.
  • The company has halted its second Phase III trial and open-label extension study of simufilam, effectively ending the drug's development program.
  • Cassava's stock price plummeted over 80% following the announcement, reflecting investor disappointment and uncertainty about the company's future.
  • Simufilam's development has been plagued by controversy, including allegations of data manipulation and investigations by the SEC and Department of Justice.

Simufilam 50 mg or 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT05026177TerminatedPhase 3
Cassava Sciences, Inc.
Posted 11/18/2021

Open-label Extension for Phase 3 Clinical Trials of Simufilam

NCT05575076TerminatedPhase 3
Cassava Sciences, Inc.
Posted 11/7/2022

Simufilam 100 mg for Mild-to-Moderate Alzheimer's Disease

NCT04994483CompletedPhase 3
Cassava Sciences, Inc.
Posted 11/3/2021

LongBio's LP-003 Receives IND Approval in China for Food Allergy Treatment

  • LongBio's LP-003, a next-generation anti-IgE antibody, has received IND approval from China's NMPA for a clinical trial targeting food allergies.
  • LP-003 offers potential advantages over existing anti-IgE therapies, including superior efficacy and a longer dosing interval of 2-3 months.
  • This marks the fourth IND approval for LP-003, with ongoing Phase III trials for allergic rhinitis and Phase II trials for CSU and asthma.
  • A head-to-head comparison of LP-003 with omalizumab in a Phase II CSU trial will be presented at the AAAAI Annual Meeting in February 2025.

UNEEG Medical's Subcutaneous EEG Implant System Receives FDA Breakthrough Device Designation for Epilepsy Monitoring

  • UNEEG Medical's Subcutaneous EEG Implant System has received FDA Breakthrough Device Designation, expediting its review for treating severe epilepsy.
  • The system offers continuous 24/7 EEG recording via a small subcutaneous device, providing long-term brain activity data for physicians.
  • The device utilizes AI-developed software to identify potential seizure activity, enabling optimized disease management and improved patient mobility.
  • The Breakthrough Designation may lead to temporary coverage and payment for the technology after FDA clearance, enhancing patient access.

RH5.1/Matrix-M Malaria Vaccine Shows Promise as Blood-Stage Defense

  • A Phase IIb trial of the RH5.1/Matrix-M vaccine shows 55% efficacy in preventing clinical malaria over six months in young children.
  • The vaccine also demonstrated over 80% efficacy against high levels of malaria parasites, suggesting potential in preventing severe cases.
  • RH5.1/Matrix-M targets the blood-stage of malaria, complementing existing vaccines that target the liver-stage of the parasite.
  • The RH5.1/Matrix-M vaccine was well-tolerated, with mild adverse events, positioning it as a potential second line of defense against malaria.

CNS Pharma's Berubicin Shows Promising Patient Retention in Recurrent GBM Trial

  • CNS Pharmaceuticals presented updated results from its pivotal study comparing Berubicin to Lomustine in recurrent glioblastoma (GBM) patients, showing comparable demographics between treatment arms.
  • The Berubicin arm exhibited higher study completion rates (84.7%) compared to Lomustine (78.9%), alongside lower withdrawal rates (11.0% vs. 19.7%), suggesting better tolerability.
  • Safety profiles were similar, with Berubicin showing slightly higher rates of anemia and neutropenia, while Lomustine had more thrombocytopenia cases.
  • The company anticipates reporting primary analysis data in the first half of 2025, with overall survival as the primary endpoint.

A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme

NCT04762069Active, Not RecruitingPhase 2
CNS Pharmaceuticals, Inc.
Posted 5/18/2021

FDA Study Links Asthma Drug Singulair to Mental Health Issues; Neurology Groups Criticize Pharma Investment

  • An FDA study reveals that Singulair (montelukast), a common asthma drug, may bind to brain receptors and is linked to severe mental health issues, including suicidal thoughts.
  • Neurology patient groups are criticizing the pharmaceutical industry for insufficient investment in treatments for nervous system disorders, citing unmet needs.
  • Pfizer reported a significant 32% increase in sales for Q3, surpassing Eli Lilly and Novo Nordisk in revenue growth among top biopharma companies.
  • Experts suggest that up to 20% of individuals may not experience significant weight loss with GLP-1 drugs like Wegovy and Mounjaro, highlighting variability in treatment response.

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