TMS-007
- Generic Name
- TMS-007
FDA Clears Corxel's Phase II Trial for Oral GLP-1 Receptor Agonist CX11 in Obesity Treatment
• Corxel Pharmaceuticals has received FDA clearance for a Phase II trial of CX11, an oral once-daily small molecule GLP-1 receptor agonist for obesity treatment, with enrollment expected to begin in Q2 2025.
• The randomized, double-blind trial will enroll 250 patients with obesity or overweight conditions across five treatment arms, with subjects receiving treatment for 36 weeks followed by a 2-week monitoring period.
• If successful, the trial could address limitations of current injectable GLP-1 therapies, with topline data expected in the first half of 2026 potentially leading to global Phase III development.
Corxel Pharmaceuticals Acquires Oral GLP-1 Agonist CX11 for Obesity and Diabetes
• Corxel Pharmaceuticals acquired global rights (excluding Greater China) to CX11, an oral small molecule GLP-1 receptor agonist, from Vincentage Pharma.
• CX11 demonstrated competitive weight loss and favorable safety in a Phase 2 trial in China, and is currently in a pivotal Phase 3 trial there.
• Corxel plans to initiate a Phase 2 clinical trial in 2025 to evaluate CX11 in obese or overweight patients, excluding China.
• The acquisition expands Corxel's cardiometabolic pipeline into obesity and diabetes, addressing a major risk factor for chronic diseases.
Ischemic Stroke Pipeline Shows Promise with Novel Therapies in Development
• Over 55 potential drugs for ischemic stroke are currently in the pipeline, targeting novel treatment approaches.
• Nelonemdaz (GNT Pharma) and 3K3A-APC (ZZ Biotech) are in Phase III trials, showing promise in neuroprotection and stroke treatment.
• JX10 (JIXING Pharmaceuticals) and Elezanumab (AbbVie) are in Phase II, exploring thrombolytic and anti-inflammatory, and neurorestorative mechanisms, respectively.
• UMC119-06 (Meridigen Biotech) is in Phase I, utilizing umbilical cord-derived MSCs for anti-oxidation and immunomodulation in stroke.
Glibenclamide Shows Promise in Improving Ambulation After Large Hemispheric Infarction
• Post-hoc analysis of the Phase 3 CHARM trial indicates that intravenous glibenclamide (CIRARA) significantly improves independent ambulation in patients with large hemispheric infarction (LHI).
• Patients with lesion volumes under 125 mL treated with CIRARA showed a significantly higher odds ratio for achieving favorable modified Rankin Scale (mRS) scores.
• CIRARA, when combined with endovascular thrombectomy (EVT), demonstrated a substantial increase in the ability of LHI patients to walk independently at 12 months.
• Remedy Pharmaceuticals is planning a confirmatory Phase 3 study of CIRARA in LHI, encouraged by the sustained effects and impact on patient ambulation.
Drug Development Updates
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