Core Insights - Skye Bioscience announced topline data from its 26-week Phase 2a CBeyond™ study of nimacimab, a CB1 inhibitor antibody targeting obesity and metabolic disorders [1][2] Study Results - The nimacimab monotherapy did not meet the primary endpoint for weight loss, showing a placebo-subtracted weight loss of -1.26% at week 26 [6][7] - In the combination cohort, nimacimab 200 mg plus semaglutide resulted in a significant weight loss of -13.2% compared to -10.25% with semaglutide alone, with a p-value of 0.0372 [3][12] - The combination therapy did not show a plateau in weight loss through Week 26, indicating potential for continued efficacy [3][12] Safety Profile - Nimacimab demonstrated a favorable safety profile, with tolerability similar to placebo and no increase in gastrointestinal adverse events when combined with semaglutide [4][9] - No neuropsychiatric adverse events were reported with nimacimab, indicating a clean safety profile [4][13] Pharmacokinetics and Dosing Insights - Preliminary pharmacokinetic analysis indicated that the 200 mg weekly dose of nimacimab was suboptimal as a monotherapy, suggesting the need for higher dosing [2][5] - The company is considering higher dosing strategies based on preclinical data and safety margins observed in the study [5][18] Future Directions - Skye plans to evaluate the next stage of development for nimacimab, including potential follow-on Phase 2 studies to optimize dosing [5][18] - Detailed results from the 26-week treatment period will be presented at ObesityWeek in November [19]

Core Insights - Skye Bioscience, Inc. has completed the treatment phase for the last patient in its Phase 2a CBeyond™ clinical trial evaluating nimacimab for obesity, with topline data expected in late Q3/early Q4 of 2025 [1][3] Group 1: Clinical Trial Details - The CBeyond™ Phase 2a trial is a randomized, double-blind, placebo-controlled study focusing on weight loss, safety, tolerability, and metabolic biomarkers in adults with obesity and overweight [2] - The primary endpoint of the trial is to compare weight change from baseline to 26 weeks between nimacimab and placebo [2] - An exploratory arm of the trial is assessing the combination of semaglutide (Wegovy®) with nimacimab versus semaglutide with placebo [2] Group 2: Study Progress and Future Plans - Skye has completed enrollment for a 26-week extension of the Phase 2a trial, which aims to provide data on 52 weeks of treatment with nimacimab, either as monotherapy or in combination with semaglutide [5] - Patients who completed the initial 26 weeks were eligible for the extension, potentially leading to a total treatment duration of 52 weeks followed by a 12-week follow-up [5] - Data from the extension study is expected to be reported in Q1 2026 [5] Group 3: Company Strategy and Market Context - Skye is focused on developing new therapeutic pathways for metabolic health, particularly through the modulation of G-protein coupled receptors [6] - The company believes that peripheral CB1 inhibition via an antibody presents a promising alternative to existing GLP-1 weight loss drugs, which may not meet all patients' needs [4] - Skye aims to advance nimacimab as a potential new therapeutic option for obesity and overweight, addressing limitations of current treatments [4]

Core Insights - NodThera has appointed Dr. Jyothis George as Chief Medical Officer, effective immediately, to lead the clinical advancement of its NLRP3 inflammasome inhibitor portfolio [1][4][5] Company Overview - NodThera is a clinical-stage biotech focused on developing brain-penetrant NLRP3 inflammasome inhibitors for chronic inflammatory diseases, with two lead clinical candidates showing potentially best-in-class profiles [6] - The company is backed by prominent investors including 5AM Ventures, Blue Owl Capital, Epidarex Capital, F-Prime Capital, Novo Holdings, Sanofi Ventures, and Sofinnova Partners [6] Leadership Experience - Dr. Jyothis George brings extensive experience in cardiometabolic drug development, having previously served as Global Medical Vice President at Amgen, where he led strategic planning for obesity treatments [2][3] - His past roles include Corporate Vice President at Novo Nordisk, where he oversaw key clinical trials for drugs like semaglutide, and Global Head of Clinical Development at Boehringer Ingelheim, where he managed pivotal programs for empagliflozin and linagliptin [3] Strategic Vision - The appointment of Dr. George is expected to enhance NodThera's clinical development efforts, leveraging his expertise in regulatory success and landmark trials to advance the company's innovative therapies [4][5] - Dr. George expressed enthusiasm about transforming treatments for diseases linked to chronic low-grade inflammation, aiming to restore metabolic balance for patients [4]

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] Enobosarm Development - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue selective for fat loss while preserving lean mass [3] - The Phase 2b QUALITY clinical trial demonstrated a statistically significant 71% relative reduction in lean mass loss for patients receiving enobosarm combined with semaglutide compared to placebo [5] - The enobosarm 3mg + semaglutide group showed a >99% mean relative reduction in loss of lean mass [5] - Enobosarm treatment resulted in a 46% greater relative loss of fat mass compared to placebo + semaglutide at 16 weeks [6] - The median total body weight loss in the enobosarm + semaglutide group was 90.6% fat loss compared to 68% in the placebo + semaglutide group, indicating a shift towards greater fat loss [6] Physical Function and Safety - The Stair Climb Test indicated that 42.6% of patients on placebo + semaglutide experienced a ≥10% decline in stair climb power, while the enobosarm + semaglutide group had a 54.4% mean relative reduction in this decline [8] - Safety data for the Phase 2b QUALITY study remains blinded, with no significant differences noted compared to previous studies of enobosarm [9] Sabizabulin Development - Sabizabulin is being explored as a treatment for inflammation in atherosclerotic cardiovascular disease, addressing a significant unmet medical need [11][14] - The drug has shown broad anti-inflammatory activity in previous studies, with a safety database consisting of 266 dosed patients [13] - A Phase 2 dose-finding proof of concept study is planned to assess the drug's efficacy in reducing inflammation associated with coronary artery disease [15]