Tagged News
Merck KGaA Joins Peregrine Ventures' Incentive Incubator as Strategic Partner
• Merck KGaA has become a strategic partner in Peregrine Ventures' Incentive Incubator, gaining early access to startups in bioconvergence, pharma, and biotechnology fields.
• The collaboration will focus on ventures with significant market potential aligned with Merck's three global divisions: Healthcare, Life Science, and Electronics, with priority given to bioconvergence ventures.
• Through this partnership, eligible startups will receive support including investments, regulatory guidance, business development assistance, and potentially early-phase trial planning.
FDA-Approved Lenire Device Shows 91.5% Success Rate in Real-World Tinnitus Treatment Study
• A new study published in Nature Communications Medicine reveals that 91.5% of tinnitus patients experienced clinically meaningful improvement after 12 weeks of treatment with the Lenire bimodal neuromodulation device.
• The retrospective analysis of 220 patients represents one of the largest real-world studies of tinnitus treatment, confirming results from previous clinical trials that led to FDA approval in March 2023.
• Lenire works by simultaneously delivering audio tones through headphones and mild electrical pulses to the tongue, offering a promising treatment option for the estimated 25 million Americans suffering from tinnitus.
Neurovation Labs Secures Patent for Novel PTSD Biomarker Detection Technology
• Neurovation Labs has been granted U.S. Patent No. 12,274,761 for technology that detects GluA1-containing AMPA receptors in the brain, enabling objective PTSD diagnosis.
• The patented radiological imaging device represents a significant advancement in mental health diagnostics by providing a physiological biomarker for a condition traditionally diagnosed through subjective assessments.
• Beyond PTSD, Neurovation Labs is exploring applications of this technology for other neurological conditions including traumatic brain injury, Alzheimer's disease, and epilepsy.
Annexon's Tanruprubart Shows Rapid and Durable Improvements in Guillain-Barré Syndrome Phase III Trial
• Tanruprubart demonstrated significant functional improvements in Guillain-Barré syndrome patients as early as one week after treatment, with patients 14 times more likely to show improved mobility versus placebo.
• The monoclonal antibody targeting C1q protein maintained durable benefits through 26 weeks, with twice as many treated patients achieving full recovery compared to placebo.
• If approved, tanruprubart could address a significant unmet need for the estimated 7,000 U.S. and 15,000 EU patients diagnosed with GBS annually, potentially representing a $1 billion market opportunity.
Related Clinical Trials:
Annexon, Inc.
Posted 12/17/2020
Alzinova Secures Funding for Phase II Alzheimer's Drug Trial Preparations
• Alzinova has successfully raised capital to advance preparations for Phase II clinical trials of its Alzheimer's disease therapeutic candidate, following promising early-stage results.
• The company is now fully focused on Phase II trial preparations, as highlighted in Carnegie's commissioned research reports and confirmed in Alzinova's Q1 review.
• This development represents a significant milestone in Alzinova's clinical pipeline, potentially offering a new approach to addressing the unmet needs in Alzheimer's disease treatment.
Neurogen Biomarking Partners with NeuroX to Revolutionize Early Alzheimer's Detection
• Neurogen Biomarking and NeuroX have formed a strategic partnership to accelerate early detection of Alzheimer's disease through an innovative patient-initiated platform combining blood biomarker testing and AI-enhanced cognitive assessments.
• The collaboration addresses critical gaps in neurological care, with NeuroX's board-certified neurologists providing telehealth support that reduces typical specialist wait times from months to weeks for the 92% of Americans with MCI who remain undiagnosed.
• Launching commercially in 2025, the integrated platform offers a comprehensive patient journey including digital cognitive assessment, at-home blood biomarker testing for ptau217, and personalized brain health action plans developed by specialists.
Riliprubart Shows Promise as First-in-Class Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
• Sanofi's riliprubart demonstrated significant disease-controlling benefits across all patient cohorts in a Phase 2 study for chronic inflammatory demyelinating polyneuropathy (CIDP), including those who failed standard treatments.
• The complement C1s inhibitor showed sustained efficacy for up to 48 weeks, with 87-92% of participants experiencing improvement or disease stabilization after 24 weeks of treatment.
• Riliprubart reduced neurofilament light chain levels by 35% across all cohorts, suggesting potential reduction in nerve damage, while also improving patient-reported fatigue and quality of life outcomes.
Related Clinical Trials:
FDA Clears Path for Cingulate's CTx-1301 ADHD Treatment NDA Submission
• The FDA has confirmed that Cingulate can proceed with its New Drug Application for CTx-1301, a novel ADHD treatment, without completing additional Phase 3 studies.
• CTx-1301 utilizes Cingulate's proprietary Precision Timed Release (PTR) technology to deliver three precisely timed doses of dexmethylphenidate in a single daily tablet, potentially benefiting over 60% of ADHD patients currently using booster doses.
• Cingulate plans to submit the NDA in the first half of 2025 and is advancing discussions with potential commercialization partners while preparing to engage with payers for market access.
FDA to Convene Advisory Committee for Eli Lilly's Alzheimer's Drug Donanemab
• The FDA has announced plans to convene a Peripheral and Central Nervous System Drugs Advisory Committee to review donanemab's efficacy and safety profile before making a final approval decision.
• Donanemab's TRAILBLAZER-ALZ 2 trial employed innovative biomarker strategies, using both Amyvid® and Tauvid™ PET scans to identify early-stage patients with confirmed amyloid plaques most likely to benefit from treatment.
• Experts view anti-amyloid therapies like donanemab as just the first line of defense, with approximately 75% of Alzheimer's drugs in development now exploring novel targets related to aging pathways including inflammation and vascular dysfunction.
Cingulate's Phase 3 Trial Shows Promising Results for Once-Daily ADHD Treatment CTx-1301
• Cingulate Inc. presented full results from its Phase 3 adult efficacy and safety trial of CTx-1301 (dexmethylphenidate) for ADHD at the 36th Annual Psych Congress, with the poster selected as a finalist for the inaugural Poster Awards.
• CTx-1301 demonstrated a trend toward significant improvement in ADHD symptoms with rapid onset and entire active-day duration, potentially offering the first true once-daily stimulant medication with no mid-day dosing requirements.
• The company has initiated additional Phase 3 studies in pediatric and adolescent populations, with plans to submit a New Drug Application to the FDA in the second half of 2024 under the Section 505(b)(2) pathway.
Related Clinical Trials:
Cingulate Therapeutics
Posted 12/29/2022