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Clinical Trial News

MBX Biosciences Submits IND Application for Once-Monthly Obesity Drug MBX 4291

  • MBX Biosciences has submitted an Investigational New Drug application to the FDA for MBX 4291, a long-acting GLP-1/GIP receptor co-agonist prodrug designed for once-monthly administration in obesity treatment.
  • The drug demonstrated similar weight loss efficacy to tirzepatide in preclinical studies while showing extended duration of action, supporting its potential for monthly dosing with improved gastrointestinal tolerability.
  • Pending IND clearance, the company plans to initiate a Phase 1 clinical trial in healthy overweight volunteers during the third quarter of 2025.
  • MBX 4291 was developed using the company's proprietary Precision Endocrine Peptide platform, which aims to overcome limitations of current peptide therapies through optimized pharmaceutical properties.

Novo Nordisk Loses Canadian Semaglutide Patent Protection Over Missed $450 Fee, Opening Door to Generics in 2026

  • Novo Nordisk permanently forfeited Canadian patent protection for semaglutide after failing to pay a routine $450 maintenance fee in 2019, clearing the path for generic competitors.
  • The patent lapse affects Ozempic and Wegovy, which generated approximately $2.5 billion in Canadian sales last year, making Ozempic the nation's top-selling drug.
  • Generic manufacturers including Sandoz, Hikma Pharmaceuticals, and Aspen Pharmacare have confirmed semaglutide dossiers ready for launch once data exclusivity expires in January 2026.
  • The decision also invalidates Novo's certificate of supplementary protection that would have extended exclusivity until March 2028, potentially costing the company two additional years of market protection.

BDD Pharma's OralogiK System Advances Timed-Release Drug Delivery for ADHD and Rheumatoid Arthritis

  • BDD Pharma has developed OralogiK, a breakthrough tablet technology that releases medication at precisely timed intervals to optimize therapeutic outcomes for conditions like ADHD and rheumatoid arthritis.
  • The system allows patients to take medication before bedtime, with the drug releasing during sleep to provide symptom relief upon waking, eliminating morning pain and stiffness.
  • The company's first OralogiK therapy for ADHD is expected to launch next year, offering once-daily dosing instead of multiple daily doses.
  • BDD Pharma recently opened a £2 million GMP manufacturing facility in Glasgow to accelerate development and maintain Scottish production capabilities.

First Patient Treated with Novel B-Cell Targeting Therapy for Myasthenia Gravis in Phase III Trial

Rare Disease
  • The first patient worldwide has been treated with Remibrutinib, a novel B-cell targeting therapy for Myasthenia Gravis, marking the start of an international Phase III clinical trial at HonorHealth Research Institute.
  • This represents the first time a drug has targeted B cells in Myasthenia Gravis treatment, offering a new mechanism of action that blocks a different part of the neuro-muscular-junction pathway than existing therapies.
  • The rare autoimmune disease affects fewer than 200 people per million, causing muscle weakness symptoms that severely impact daily activities like brushing teeth and getting dressed.
  • If successful, the trial could lead to FDA approval for Remibrutinib in Myasthenia Gravis, with the drug already approved for certain cancer types.

Alzamend Neuro Completes $5 Million Financing to Advance Five Phase II Trials for AL001 Lithium Therapy

  • Alzamend Neuro completed a $5 million private placement months ahead of schedule to fund five Phase II clinical trials of AL001 "Lithium in Brain" studies at Massachusetts General Hospital.
  • The company's AL001 drug candidate uses patented ionic cocrystal technology to deliver lithium via a therapeutic combination of lithium, salicylate and L-proline for treating neurological and psychiatric conditions.
  • Five Phase II trials are planned across multiple indications, with the first healthy subject trial initiated in May 2025 and additional trials for bipolar disorder, Alzheimer's disease, major depressive disorder and PTSD expected to commence through Q4 2025.
  • The financing targets treatment solutions for over 43 million Americans afflicted with Alzheimer's disease, bipolar disorder, major depressive disorder and post-traumatic stress disorder.

ZIRCON Phase 3 Trial Demonstrates High Accuracy of Novel PET Tracer for Kidney Cancer Detection

  • The ZIRCON phase 3 trial evaluated 89Zr-TLX250 PET tracer for characterizing small renal masses, achieving greater than 85% accuracy in identifying clear cell renal cell carcinoma.
  • The novel molecular imaging approach demonstrated exceptional positive predictive value of 93-95% for ccRCC, with all positive cases indicating malignancy even when not specifically ccRCC.
  • This represents a significant advance in noninvasive kidney cancer diagnosis, potentially reducing unnecessary interventions while providing actionable clinical information for treatment decisions.

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

NCT03849118CompletedPhase 3
Telix Pharmaceuticals (Innovations) Pty Limited
Posted 8/15/2019

CDC Sponsors First Clinical Trial of Needle-Free Rotavirus Vaccine Using Dissolvable Microarray Patch Technology

  • Emory University and Micron Biomedical have launched the first CDC-sponsored clinical trial of a rotavirus vaccine delivered via dissolvable microarray patch technology, marking a significant milestone in needle-free vaccine administration.
  • The Phase I trial will evaluate CC24, a novel inactivated rotavirus vaccine developed by the CDC, using Micron's painless patch technology that eliminates cold chain requirements and medical waste.
  • The study addresses a critical global health need, as current oral rotavirus vaccines show reduced effectiveness in low- and middle-income countries where childhood diarrheal deaths from rotavirus remain highest.
  • The trial will recruit 50 healthy adults aged 18-45 to assess safety, reactogenicity, and immunogenicity, with results informing future pediatric studies for this life-saving vaccine innovation.

Teva and Fosun Pharma Form Strategic Partnership for Novel Anti-PD1-IL2 Cancer Immunotherapy TEV-56278

Oncology
  • Teva Pharmaceutical and Fosun Pharma announced a strategic partnership to develop TEV-56278, an anti-PD1-IL2 ATTENUKINE therapy currently in Phase 1 trials for various cancers including melanoma.
  • Under the agreement, Fosun Pharma receives exclusive rights to develop, manufacture and commercialize TEV-56278 in China, Hong Kong, Macau, Taiwan and select Southeast Asian countries while Teva retains global rights elsewhere.
  • TEV-56278 represents a novel cancer immunotherapy approach designed to selectively deliver IL-2 to PD-1+ T cells within tumors, potentially amplifying anti-tumor activity while minimizing systemic toxicities.
  • Preclinical data has demonstrated tumor regression, enhanced T-cell infiltration, and durable immune memory, with the therapy being evaluated both as monotherapy and in combination with pembrolizumab.

Debiopharm Initiates First-in-Human Trial of CD37-Targeted ADC Debio 1562M for Relapsed/Refractory AML

Monoclonal AntibodyOncologyTargeted Therapy
  • Debiopharm has dosed the first patient in a Phase 1/2 trial of Debio 1562M, a first-in-class CD37-targeted antibody-drug conjugate for relapsed/refractory acute myeloid leukemia patients.
  • The compound utilizes Debiopharm's proprietary Trifecta approach, combining naratuximab antibody, MultiLink™ linker technology, and a microtubule inhibitor payload to target CD37 antigens on leukemic cells.
  • AML represents a significant unmet medical need with only 32% five-year overall survival and median survival as low as 7 months in certain populations.
  • Preclinical studies demonstrated Debio 1562M showed anti-leukemic activity across all AML subtypes and superior activity compared to current standard-of-care therapies.

A Study to Assess the Safety, Tolerability, and Antileukemic Activity of Debio 1562M in Participants With Acute Myeloid Leukemia (AML)

NCT06969430RecruitingPhase 1
Debiopharm International SA
Posted 5/30/2025

AbbVie's VERONA Trial for High-Risk Myelodysplastic Syndrome Fails to Meet Primary Survival Endpoint

  • AbbVie's Phase 3 VERONA trial evaluating venetoclax plus azacitidine in newly diagnosed higher-risk myelodysplastic syndrome failed to meet its primary endpoint of overall survival with a hazard ratio of 0.908 and p-value of 0.3772.
  • The global randomized controlled trial compared venetoclax in combination with azacitidine versus azacitidine plus placebo, with no new safety signals observed during the study.
  • The negative results do not impact venetoclax's current approved indications for chronic lymphocytic leukemia, small lymphocytic lymphoma, and acute myeloid leukemia in elderly patients or those unsuitable for standard chemotherapy.
  • Full trial results will be presented at a future medical congress or publication, with participating patients being informed by their treating physicians about the study outcomes.

A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

NCT02942290Active, Not RecruitingPhase 1
AbbVie
Posted 1/12/2017

Study Of Venetoclax Tablet With Intravenous or Subcutaneous Azacitidine to Assess Change in Disease Activity In Adult Participants With Newly Diagnosed Higher-Risk Myelodysplastic Syndrome

NCT04401748Active, Not RecruitingPhase 3
AbbVie
Posted 9/10/2020

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

NCT06012240Active, Not RecruitingPhase 3
AbbVie
Posted 10/11/2023

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