Core Viewpoint - SciSparc Ltd. has announced an advancement in its collaboration with NeuroThera Labs Inc. by filing a patent application for a novel combination therapy targeting depression, which involves 5-methoxy-2-aminoindane (MEAI) and N-Acylethanolamines like Palmitoylethanolamide (PEA) [1][2] Group 1: Collaboration and Patent Filing - The patent application is a result of the ongoing collaboration between Neurothera and Clearmind Medicine Inc., focusing on a therapy for depression using MEAI and PEA [2][3] - This new filing expands the joint intellectual property portfolio, with a total of 13 patents filed through the collaboration, addressing various conditions including alcohol use disorder, cocaine addiction, obesity, and depression [3] Group 2: Market Context and Impact - According to the World Health Organization, approximately 332 million people globally suffer from major depressive disorder, representing about 5.7% of adults, with higher prevalence in women (6.9%) compared to men (4.6%) [2] - Depression remains one of the leading causes of disability worldwide, significantly contributing to the global burden of disease [2] Group 3: Company Overview - SciSparc Ltd. focuses on clinical-stage pharmaceutical developments through its majority-owned subsidiary Neurothera Labs Inc., which is engaged in developing cannabinoid-based therapeutics [4] - The company is involved in various drug development programs targeting conditions such as Tourette syndrome, Alzheimer's disease, and autism spectrum disorder [4][5]

Core Insights - The article emphasizes the potential of investing in smaller, lesser-known biotech companies alongside established market leaders, highlighting Viking Therapeutics and Axsome Therapeutics as promising candidates for growth in the biotech sector [1][2]. Viking Therapeutics - The weight loss market is projected to grow from $15 billion last year to $150 billion by 2035, driven by breakthroughs and increasing demand for obesity-related treatments [3]. - Viking Therapeutics is developing VK2735, a dual GLP-1/GIP agonist, currently in phase 3 trials for subcutaneous use, with promising efficacy observed in mid-stage trials for an oral formulation [4]. - The company is also working on another weight-loss candidate in preclinical studies and plans to initiate human clinical trials next year, alongside VK2809, which has completed phase 2 studies for metabolic dysfunction-associated steatohepatitis [7]. Axsome Therapeutics - Axsome Therapeutics has achieved significant clinical and regulatory advancements, with third-quarter revenue reaching $171 million, a 63% year-over-year increase, primarily due to its depression medication, Auvelity [9]. - Auvelity, launched in 2022, is expected to achieve blockbuster status in treating depression and is awaiting approval for use in Alzheimer's disease agitation, with potential peak sales estimated between $1.5 billion to $3 billion [10][11]. - The company has a robust pipeline with other approved products and ongoing late-stage trials, including AXS-12 for narcolepsy and AXS-14 for fibromyalgia, which are expected to enhance financial performance [12][13].

Xanamem Clinical Trial & Results - Xanamem demonstrated clinically and statistically significant benefits in depression symptoms in the XanaCIDD phase 2a trial, with a 2.7-point difference compared to placebo at the post-treatment follow-up (p < 0.05)[5] - Phase 2a data suggests a greater benefit on CDR-SB in high pTau181 patients, with a mean change from baseline of 0.6 units compared to placebo in a study of 34 participants (p = 0.09)[8] - Human PET study shows extensive binding of Xanamem to the 11β-HSD1 enzyme throughout the brain after 7 days of daily dosing at 5mg, 10mg and 20mg doses[10] XanaMIA Trial Design & Expectations - The XanaMIA trial is designed with 220 participants and includes an interim analysis at 24 weeks with N=100, with initial interim results expected in January 2026 and final results in Q4 2026[16] - The primary endpoint for the XanaMIA trial is CDR-SB (functional and cognitive measure) at 36 weeks, with key secondary endpoints including a cognitive test battery and the Amsterdam Activity of Daily Living[16] - The company hopes Xanamem will be better than anti-amyloid drugs on the primary endpoint of CDR-SB and other endpoints[21] Commercialization & Market Potential - The anti-depressant market is currently approximately $20 billion, with significant opportunities for novel mechanisms and better-tolerated drugs[34] - The Alzheimer's market is projected to reach $20 billion by 2030, presenting a major opportunity for a safe and effective oral agent like Xanamem[34] - US neurologists indicate that uptake of a safe and effective oral drug for Alzheimer's would be rapid, potentially positioning Xanamem as a first-line therapy[29]

Core Insights - Actinogen Medical Limited is progressing with its Phase 2b/3 trial for Alzheimer's disease, expecting to enroll 100 participants by the end of the current quarter, which will trigger an interim analysis in approximately six months [1][2][3] Group 1: Trial Progress and Design - The XanaMIA trial is designed to enroll 220 participants with biomarker-positive, mild to moderate Alzheimer's disease, specifically those with elevated blood biomarker pTau181 [2][13] - Currently, 60 participants have entered the treatment phase, with an additional 35 expected to enroll soon as recruitment accelerates with new clinical sites in the US, bringing the total to 35 sites [3][13] - The primary endpoint of the trial is the Clinical Dementia Rating – Sum of Boxes scale, with additional measures assessing cognition and functional ability [2][13] Group 2: FDA Interactions and Future Plans - Actinogen had a successful meeting with the FDA regarding its Major Depressive Disorder (MDD) program, which provided guidance for additional clinical trials needed for marketing approval of Xanamem [4][5] - A similar Type C meeting for Alzheimer's disease is scheduled with the FDA's Neurology Division later in 2025 to outline the path to marketing approval [5] Group 3: Mechanism and Future Applications - Xanamem, the lead compound, aims to control cortisol levels in the brain, which is linked to cognitive decline and depressive symptoms [15][16] - The company plans to explore Xanamem's potential in treating other neurological and psychiatric conditions, including Fragile X Syndrome [12][15] Group 4: Upcoming Events and Engagement - Actinogen will host a Clinical Trials Science Forum webinar on May 14, 2025, to discuss current and potential treatments for Alzheimer's disease and commercialization planning [7][8]