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Clinical Trial News

Novo Nordisk's Monlunabant Fails to Meet Expectations in Phase II Trial for Weight Management

  • Novo Nordisk's monlunabant did not demonstrate sufficient efficacy in a Phase II trial for weight management, leading to the termination of its development program.
  • The trial assessed monlunabant's impact on body weight compared to placebo over a specified period, with results falling short of predefined success criteria.
  • This decision reflects the challenges in developing effective and safe CB1 receptor inverse agonists for obesity treatment, despite initial promise.
  • The setback underscores the high-risk nature of pharmaceutical R&D, particularly in complex metabolic disorders like obesity.

Phase 3 MOGwAI Trial Investigates Azathioprine for First-Line MOGAD Treatment

  • The MOGwAI trial (NCT05349006) is a phase 3 study evaluating azathioprine's efficacy in preventing relapses in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).
  • This multicenter study spans 14 institutions and aims to enroll 126 patients, monitoring them over a 36-month treatment period to assess relapse rates.
  • The primary endpoint is the time to first relapse, comparing azathioprine to placebo, while secondary endpoints include safety, EDSS score changes, visual acuity, and quality of life.
  • Enrollment began in December 2023, with study completion expected in early 2026; eligibility includes adults with a recent first attack of acute demyelinating syndrome and positive MOG-antibody tests.

Azathioprine in MOGAD

NCT05349006RecruitingPhase 3
Hospices Civils de Lyon
Posted 12/12/2023

Cabozantinib Significantly Improves Progression-Free Survival in Advanced Neuroendocrine Tumors

  • Phase III CABINET trial demonstrates cabozantinib significantly improves progression-free survival (PFS) in advanced pancreatic and extrapancreatic neuroendocrine tumors (NETs).
  • In pNET patients, median PFS was 13.8 months with cabozantinib versus 4.4 months with placebo (HR 0.23, p<0.0001); in epNET, 8.4 versus 3.9 months (HR 0.38, p<0.0001).
  • The FDA has accepted a supplemental new drug application (sNDA) for cabozantinib, with a target action date of April 3, 2025, and granted Orphan Drug Designation for pNET.
  • Cabozantinib could become a new standard of care for previously treated advanced NETs, offering a clinically meaningful treatment benefit across major clinical subgroups.

Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors

NCT03375320Active, Not RecruitingPhase 3
National Cancer Institute (NCI)
Posted 10/26/2018

Oxford Drug Design Achieves In Vivo Validation of AI-Discovered Cancer Therapeutic

  • Oxford Drug Design's AI platform, SynthAI, has yielded a novel cancer therapeutic demonstrating significant tumor regression in initial in vivo mouse trials.
  • The therapeutic, targeting tRNA-synthetase, showed a well-defined dose response in MCF7 breast cancer cells, suggesting potential for improved efficacy.
  • Further in vivo studies are planned against colorectal cancer and other tumor types, with ongoing optimization to enhance drug candidate properties.
  • Oxford Drug Design is seeking investment to advance the program towards clinical trials, aiming to deliver superior therapeutic options for oncologists.

FDA Approves Roche's Injectable Ocrevus, Novartis' Kisqali, and Lilly's Ebglyss; WHO Clears Bavarian Nordic’s Mpox Vaccine

• Roche's Ocrevus gains FDA approval for an injectable version, offering a new administration option for multiple sclerosis patients. • Novartis' Kisqali receives FDA approval to reduce the risk of recurrence in HR+/HER2- early breast cancer, expanding treatment options. • Lilly's Ebglyss (lebrikizumab-lbkz) is approved for moderate-to-severe atopic dermatitis in adults and children 12 years and older. • The World Health Organization clears Bavarian Nordic’s mpox vaccine, marking the first WHO-approved shot for mpox containment.

CHMP Recommends Approval of Henlius and Intas' Serplulimab for ES-SCLC in Europe

  • The CHMP has issued a positive opinion for serplulimab (HETRONIFLY®), recommending its approval in Europe for ES-SCLC treatment.
  • Serplulimab, developed by Henlius and to be commercialized by Intas, is a recombinant humanized anti-PD-1 monoclonal antibody.
  • The recommendation is based on the ASTRUM-005 trial, which showed serplulimab plus chemotherapy improved outcomes in ES-SCLC.
  • If approved, serplulimab will be the first anti-PD-1 monoclonal antibody available in Europe for first-line treatment of ES-SCLC.

Inavolisib Demonstrates Promising Disease Control in PIK3CA-Mutated Solid Tumors

• Interim results from the CRAFT trial show inavolisib achieved a 36% disease control rate at day 110 in patients with PIK3CA-mutated solid tumors. • The most common adverse event was hyperglycemia, but inavolisib generally exhibited a manageable safety profile in the trial. • The FDA previously granted priority review to inavolisib in combination with palbociclib and fulvestrant for HR+/HER2- breast cancer with PIK3CA mutation. • Further research is ongoing to clarify inavolisib’s efficacy and safety across various disease states and identify potential response predictors.

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/29/2020

CRAFT: The NCT-PMO-1602 Phase II Trial

NCT04551521CompletedPhase 2
German Cancer Research Center
Posted 10/13/2021

AVMA Veterinary Clinical Trials Registry Highlights New Studies in Canine and Feline Oncology and Neurological Disorders

  • The AVMA Veterinary Clinical Trials Registry lists studies for animal health, connecting researchers with veterinarians and owners.
  • North Carolina State University is exploring a novel treatment approach for oral cancer in cats.
  • Several studies are investigating canine cancers, including hemangiosarcoma, osteosarcoma, and mast cell tumors, with innovative therapies.
  • Research is underway to assess treatments for canine cognitive dysfunction and degenerative myelopathy, mirroring human neurological conditions.

EMA Recommends Approvals for Novel Therapies Targeting Cancer, Hemophilia, and Neurological Disorders

  • The EMA's CHMP recommended ten new medicines for approval, including Alhemo for hemophilia and Wainzua for hereditary transthyretin-mediated amyloidosis.
  • Positive opinions were adopted for two influenza vaccines, Fluad and Flucelvax, and for Siiltibcy, a diagnostic for Mycobacterium tuberculosis infection.
  • CHMP recommended extensions of indication for twelve already authorized medicines, expanding treatment options for various conditions.
  • The committee elected Bruno Sepodes as its new chair and Outi Mäki-Ikola as its new vice-chair, effective September and October 2024, respectively.

Apellis' Syfovre Rejected Again in Europe for Geographic Atrophy

• The European Medicines Agency reaffirmed its rejection of Apellis' Syfovre for treating geographic atrophy, despite the company's efforts to re-evaluate the supporting evidence. • This decision prevents Syfovre from entering the European market, where approximately 2.5 million individuals are affected by geographic atrophy, an irreversible cause of blindness. • The rejection was based on concerns that Syfovre did not demonstrate clinically meaningful benefits and carried significant risks of adverse events with regular injections. • Apellis plans to restructure its European operations and reduce its workforce by about 40 employees following the negative outcome, while awaiting decisions in other regions.

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