August 6, 2024 - 🧬 [nGram] Today’s Neurology Scoop: Alzamend Neuro's Phase II Trial, Telitacicept Enrollment, ProMIS Data on ALS


  1. Alzamend Neuro partners with Massachusetts General Hospital for a Phase II clinical trial of AL001
    • Alzamend Neuro collaborates with Massachusetts General Hospital to conduct a Phase II clinical trial of AL001 for Alzheimer's patients.
    • The trial will compare lithium levels in the brain between Alzheimer's patients and healthy subjects.
    • Dr. Ovidiu Andronesi from Harvard University will be the principal investigator.
    • The study aims to meet regulatory safety standards for FDA approval through the Section 505(b)(2) pathway.
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  2. First patient enrollment in the U.S. - A milestone for the global multi-center phase â…¢ clinical trial of telitacicept for myasthenia gravis
    • RemeGen's telitacicept has achieved first patient enrollment in the U.S. for its global phase III trial for generalized myasthenia gravis (gMG).
    • The trial is a multicenter, randomized, double-blind, placebo-controlled study aiming to recruit 180 patients globally.
    • Telitacicept targets BLyS and APRIL, reducing pathogenic antibodies and improving clinical status in gMG patients.
    • Previously granted orphan drug and fast track status by the FDA and breakthrough therapy designation by China's NMPA.
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  3. ProMIS Neurosciences announces data on the pathogenic role of toxic misfolded SOD1 aggregates in ALS
    • ProMIS Neurosciences published two papers on the role of toxic misfolded SOD1 aggregates in ALS.
    • The Acta Neuropathologica paper reports on the presence of aggregated SOD1 seeds in both familial and sporadic ALS.
    • The Open Biology paper highlights the importance of amyloidogenic regions in β-strands II and III in SOD1 aggregation and toxicity.
    • These findings support targeting misfolded SOD1 as a therapeutic strategy and potential biomarker for ALS.
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  4. SEED Therapeutics enters into strategic research collaboration with Eisai
    • SEED and Eisai will collaborate to discover and develop novel molecular glue degraders for neurodegeneration and oncology.
    • SEED will receive up to $1.5 billion in upfront and milestone payments, plus tiered royalties.
    • Eisai will have exclusive rights to develop and commercialize compounds from the collaboration.
    • SEED concurrently launched Series A-3 financing, raising $24 million with a second close targeted for Q4 2024.
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  5. Cognigenics announces groundbreaking publication on shRNA treatment for 5-HT2A receptor knockdown
    • Cognigenics published research on using shRNA to knockdown the 5-HT2A receptor, improving memory and reducing neural excitability.
    • The study demonstrated significant cognitive improvements and neuronal stability in both in vivo and in vitro models.
    • This approach could lead to novel treatments for neurocognitive and neuropsychiatric diseases.
    • Cognigenics aims to develop long-term, noninvasive genetic treatments with minimal side effects.
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  6. Neumora Therapeutics reports second quarter 2024 financial results and provides business update
    • Phase 3 data from KOASTAL-1 study of navacaprant in major depressive disorder (MDD) expected in Q4 2024.
    • Progressing clinical studies in MDD, bipolar depression, and Alzheimer’s disease agitation.
    • Strong financial position with $371.6 million in cash, cash equivalents, and marketable securities.
    • Research and development expenses increased to $48.6 million in Q2 2024 from $32.8 million in Q2 2023.
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  7. Levicept announces positive results of phase II trial of novel neurotrophin-3 inhibitor, LEVI-04, for the treatment of patients with moderate to severe osteoarthritis
    • Phase II trial of LEVI-04 met all primary and secondary efficacy endpoints, showing significant analgesia across all measures for all doses.
    • The study enrolled over 510 participants with knee osteoarthritis and was conducted across Europe and Hong Kong.
    • LEVI-04 demonstrated a greater than 50% reduction in WOMAC pain scores from baseline at Week 17 for all doses.
    • The treatment was well tolerated with no increase in incidence of rapidly progressive osteoarthritis compared to placebo.
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