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Clinical Trial News

Gan & Lee's Bofanglutide Shows Superior Efficacy to Semaglutide in Phase 2 Diabetes Trials

  • Gan & Lee Pharmaceuticals presented Phase 2 clinical results at ADA's 85th Scientific Sessions showing bofanglutide injection outperformed semaglutide in HbA1c reduction and weight loss in type 2 diabetes patients.
  • The ultra-long-acting GLP-1 receptor agonist bofanglutide achieved superior HbA1c reductions of up to 2.98% compared to semaglutide's 2.04% in drug-naïve patients with statistical significance (p<0.001).
  • The company's once-weekly basal insulin analog GZR4 demonstrated comparable efficacy to insulin degludec while requiring 40-50% lower weekly dosing in patients with inadequate glycemic control.
  • Both investigational therapies showed favorable safety profiles with no severe hypoglycemic events reported, positioning Gan & Lee to advance large-scale Phase 3 programs in China.

A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus

NCT06202079CompletedPhase 2
Gan and Lee Pharmaceuticals, USA
Posted 8/11/2023

A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)

NCT06256523CompletedPhase 1
Gan and Lee Pharmaceuticals, USA
Posted 6/29/2022

A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus

NCT06256549Active, Not RecruitingPhase 2
Gan and Lee Pharmaceuticals, USA
Posted 8/9/2023

Medtronic's MiniMed 780G System Shows Promise for Type 2 Diabetes and Young Children with Type 1 Diabetes

  • Medtronic's MiniMed 780G automated insulin delivery system demonstrated significant improvements in glycemic control for adults with insulin-intensive type 2 diabetes, achieving 84.9% time in range and reducing HbA1c from 7.7% to 6.9%.
  • The LENNY trial published in The Lancet Diabetes & Endocrinology showed young children aged 2-6 years with type 1 diabetes achieved 0.6% lower HbA1c and 9.9% higher time in range compared to manual mode.
  • Parents and caregivers reported improved sleep quality and reduced fear of hypoglycemia when children used the system's auto mode, highlighting the technology's impact on family quality of life.
  • The American Diabetes Association's 2025 Standards of Care now endorse automated insulin delivery systems for adults with insulin-intensive type 2 diabetes, validating the expanding role of diabetes technology.

Verdiva Bio Advances Once-Weekly Oral GLP-1 and Amylin Therapies for Obesity Treatment

  • Verdiva Bio's Phase 1 data for VRB-101 demonstrates that the oral GLP-1 receptor agonist achieved drug levels comparable to or exceeding current once-weekly injectable therapies.
  • The company's VRB-103 amylin analog showed additive weight reduction effects when combined with VRB-101 in preclinical studies.
  • Both compounds represent the only known once-weekly oral amylin and GLP-1 receptor agonist candidates advancing into clinical development.
  • The combination therapy can be co-formulated into a single tablet while maintaining comparable plasma exposure for both compounds.

Oncology Pharmacists Demonstrate Significant Cost Savings and Expanded Clinical Roles Through Remote Services and AI Integration

AI
  • Remote clinical pharmacy services achieved $8.9 million in cost savings across 5,600 oncology patients through interventions like dose adjustments and therapeutic interchanges, with a 93% acceptance rate from clinicians.
  • Pharmacist-led medication reconciliation in phase 1 clinical trials required intensive 45-minute patient consultations but successfully identified underreported medications including cannabis and herbal supplements across 525 patients in 82 trials.
  • AI technology showed promise in oncology decision-making with 90% accuracy in identifying correct answers, though expert oncologists' responses were preferred 75% of the time, highlighting the continued need for human clinical judgment.
  • Drug shortages of cisplatin and carboplatin forced treatment pathway shifts toward immunotherapies in lung cancer, emphasizing pharmacists' critical role in developing contingency plans and managing therapeutic alternatives.

EMA Initiates Review of Sodium Oxybate for Alcohol Dependence Following Efficacy and Safety Concerns

  • The European Medicines Agency has launched a comprehensive review of sodium oxybate medicines used to treat alcohol withdrawal syndrome and support long-term abstinence following concerns raised by French regulators.
  • The review was triggered by effectiveness concerns based on data from three studies and potential abuse risks due to the drug's psychoactive properties affecting the brain.
  • Sodium oxybate works by targeting GABA receptors in the brain and spinal cord, providing a calming effect similar to alcohol's mechanism of action.
  • The Committee for Medicinal Products for Human Use will assess the overall benefit-risk balance and review current risk mitigation measures before making regulatory recommendations.

Phase 2 Trial Shows Promising Survival Rates for Stem Cell Transplants from Mismatched Unrelated Donors

  • A phase 2 trial demonstrated 83.8% one-year survival for patients receiving stem cell transplants from HLA-mismatched unrelated donors using post-transplant cyclophosphamide prophylaxis.
  • The study enrolled 145 patients with advanced hematologic malignancies, with 59% from underrepresented racial and ethnic groups who typically face challenges finding matched donors.
  • Results showed low rates of severe graft-versus-host disease, with grades 3-4 acute GVHD occurring in only 8-10% of patients at six months.
  • The findings could expand access to curative stem cell transplants by loosening HLA matching criteria to virtually 100% of patients regardless of ancestry.

RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients

NCT03797196Active, Not RecruitingPhase 4
University Medical Center Groningen
Posted 7/29/2019

HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

NCT04904588Active, Not RecruitingPhase 2
Center for International Blood and Marrow Transplant Research
Posted 9/30/2021

PharmAla Files C$50 Million Shelf Prospectus to Advance MDMA Drug Development

  • PharmAla Biotech filed a preliminary base shelf prospectus enabling the company to raise up to C$50 million over 25 months to support growth strategy and novel MDXX molecule development.
  • The biotechnology company is uniquely positioned as the only provider of clinical-grade MDMA for patient treatments outside of clinical trials, addressing global supply shortages.
  • PharmAla's research pipeline includes lead drug candidate ALA-002 and focuses on developing novel drugs in the MDXX class, including its proprietary LaNeo™ MDMA formulation.
  • The shelf prospectus provides flexibility for various financing options including at-the-market distributions, though the company has no immediate plans for securities issuance.

GLP-1 Diabetes Drug Liraglutide Reduces Migraine Days by Half in Pilot Study

  • A 12-week pilot study of 26 adults with obesity and chronic migraines found that liraglutide, a GLP-1 diabetes drug, reduced average monthly headache days from 20 to approximately 9.
  • Nearly half of patients experienced at least a 50% reduction in headache days, with migraine disability scores cut by more than half on standard impact scales.
  • Researchers hypothesize the benefit comes from lowering cerebrospinal fluid pressure in the brain rather than weight loss, as participants lost only minimal weight during the study.
  • The findings suggest GLP-1 drugs may target alternative pathways for migraine treatment, offering hope for patients with unmet medical needs beyond current therapies.

CanSinoBIO Launches iPneucia® 13-Valent Pneumococcal Vaccine Optimized for Chinese Children

  • CanSino Biologics has launched iPneucia®, a 13-valent pneumococcal conjugate vaccine specifically optimized for China's local pneumococcal epidemiology to protect Chinese children.
  • The vaccine targets four high-burden serotypes (19F, 19A, 7F, and 3) that account for over 60% of pneumococcal cases in Chinese children, with clinical data showing significantly higher antibody concentrations against these serotypes.
  • iPneucia® features innovative dual-carrier conjugate technology using CRM197 and tetanus toxoid proteins, avoiding immune interference and enhancing safety by eliminating formaldehyde detoxification requirements.

Regeneron Expands Patent Protection for Aflibercept with New Formulation Patent Against Amgen

  • Regeneron filed a new patent infringement complaint against Amgen on June 17, 2025, asserting U.S. Patent No. 12,331,099 covering a stable liquid ophthalmic formulation without buffer requirements.
  • The Patent Trial and Appeal Board denied inter partes review petitions from Samsung Bioepis and Formycon challenging Regeneron's earlier aflibercept patent, citing substantial investment in parallel district court proceedings.
  • Amgen's biosimilar PAVBLU launched commercially in November 2024 after the Federal Circuit denied Regeneron's preliminary injunction motion on a separate patent covering buffered formulations.

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