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Clinical Trial News

CB1 Agonist Trial Results Trigger Stock Drop for Corbus and Novo Nordisk

  • Novo Nordisk's monlunabant trial, targeting the CB1 receptor for weight loss, showed significant weight loss but also neuropsychiatric side effects, causing investor concern.
  • Corbus Pharmaceuticals, developing a similar CB1 agonist (CRB-913), saw its stock plummet due to the market's negative reaction to Novo Nordisk's trial results.
  • Monlunabant resulted in an average weight loss of 7.1 kg versus 0.7 kg in the placebo group, but safety concerns and limited dose-response raise questions about commercial viability.

CHMP Recommends Aflibercept Biosimilar OPUVIZ for Retinal Disorders

• The European Medicines Agency's CHMP has issued a positive opinion for OPUVIZ, an aflibercept biosimilar developed by Samsung Bioepis and Biogen. • OPUVIZ is recommended for treating neovascular age-related macular degeneration, macular edema secondary to retinal vein occlusion, and diabetic macular edema. • A Phase 3 trial demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics between OPUVIZ and reference aflibercept. • If approved by the European Commission, OPUVIZ will be the second ophthalmology biosimilar in Samsung Bioepis' portfolio commercialized by Biogen.

FDA Approves Astellas' Vyloy (Zolbetuximab) for Advanced Gastric and GEJ Adenocarcinoma

  • The FDA has approved zolbetuximab (Vyloy) in combination with chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma.
  • Approval was based on SPOTLIGHT and GLOW trials, demonstrating statistically significant improvements in progression-free and overall survival compared to chemotherapy alone.
  • The VENTANA CLDN18 (43-14A) RxDx Assay from Roche was also approved as a companion diagnostic to identify patients eligible for Vyloy treatment.
  • Vyloy is now approved in five markets worldwide, offering a new targeted therapy option for a subset of gastric and GEJ cancer patients.

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer

NCT05365581RecruitingPhase 1
Astellas Pharma Global Development, Inc.
Posted 6/7/2022

A Study of Zolbetuximab (IMAB362) in Adults With Pancreatic Cancer

NCT03816163Active, Not RecruitingPhase 2
Astellas Pharma Global Development, Inc.
Posted 3/15/2019

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).

NCT03653507Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 11/28/2018

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.

NCT03504397Active, Not RecruitingPhase 3
Astellas Pharma Global Development, Inc.
Posted 6/21/2018

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT03462719Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 4/17/2018

Intravascular Lithotripsy Advances with Multiple Companies Pursuing Clinical Trials

  • Amplitude Vascular Systems is conducting a pivotal trial (POWER-PAD-II) for its Pulse IVL system after receiving FDA IDE approval for treating peripheral artery disease.
  • Elixir Medical reported positive data from the PINNACLE I trial, demonstrating a 98% clinical success rate using its LithiX Hertz catheter system for calcified lesions.
  • FastWave Medical announced positive results from a first-in-human study of its IVL technology, showing promise for treating peripheral artery disease in the superficial femoral and popliteal arteries.
  • Bolt Medical completed enrollment in its RESTORE ATK pivotal trial, assessing its laser-based IVL system for peripheral artery disease, with data expected later this year.

POWER: Pulse Intravascular Lithotripsy (Pulse IVL) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling

NCT05192473Active, Not RecruitingNot Applicable
Amplitude Vascular Systems, Inc.
Posted 6/28/2022

FDA Updates: Approvals for RSV Vaccine, Pneumococcal Vaccine, and TB Drug Alongside Device Recalls

  • The FDA granted traditional approval to Sirturo (bedaquiline) for treating rifampin- and isoniazid-resistant tuberculosis in adults and children, based on Phase 3 STREAM study data.
  • mResvia, an mRNA-based vaccine, received FDA approval for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults aged 60 years and older.
  • Capvaxive, a pneumococcal 21-valent conjugate vaccine, was approved for preventing invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older.
  • Several critical care medical devices, including infusion pumps and chest compression devices, were recalled due to potential for serious adverse health consequences.

The Evaluation of a Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB

NCT02409290CompletedPhase 3
IUATLD, Inc
Posted 3/1/2016

Sanofi's Tolebrutinib Shows Promise in Non-Relapsing Secondary Progressive MS

  • Tolebrutinib demonstrated a 31% reduction in the time to onset of confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
  • A nearly two-fold increase in confirmed disability improvement was observed with tolebrutinib compared to placebo, suggesting potential for disease modification.
  • Sanofi plans to submit tolebrutinib for global regulatory approvals in the second half of 2024, marking a significant step towards addressing unmet needs in nrSPMS.
  • While showing promise in nrSPMS, tolebrutinib failed to meet primary endpoints in relapsing MS trials, highlighting the drug's specific efficacy profile.

Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

NCT04411641CompletedPhase 3
Sanofi
Posted 9/24/2020

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

NCT04410978CompletedPhase 3
Sanofi
Posted 6/30/2020

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

NCT04410991CompletedPhase 3
Sanofi
Posted 6/11/2020

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

NCT04458051Active, Not RecruitingPhase 3
Sanofi
Posted 8/13/2020

Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis

NCT05132569TerminatedPhase 3
Sanofi
Posted 12/3/2021

ECU Health Pioneers Pacemaker Implantation with EluPro BioEnvelope

  • ECU Health performed the first pacemaker implantation using Elutia's FDA-approved EluPro BioEnvelope, designed to prevent post-operative complications.
  • The EluPro BioEnvelope is the first antibiotic-eluting device for Cardiac Implantable Electronic Devices (CIEDs), addressing infection risks in vulnerable patients.
  • This advancement aims to improve patient outcomes and reduce complications associated with traditional pacemaker implantation procedures, especially for those with comorbidities.
  • The procedure highlights ECU Health's commitment to providing advanced cardiovascular care and reducing health disparities in eastern North Carolina.

Novo Nordisk's $1bn Oral Weight Loss Drug Shows Promise but Raises Questions in Phase IIa Trial

  • Novo Nordisk's monlunabant, an oral cannabinoid receptor 1 inverse agonist acquired for $1bn, demonstrated statistically significant weight loss in a Phase IIa trial but raised concerns about optimal dosing.
  • The 10mg dose achieved a 7.1kg weight reduction compared to 0.7kg with placebo, but higher doses showed limited additional benefit while increasing dose-dependent gastrointestinal and neuropsychiatric side effects.
  • Investor confidence wavered with Novo Nordisk's stock dropping over 6% following the announcement, as the company plans a Phase IIb trial next year to better determine the optimal efficacy-to-safety ratio.

Study of INV-202 in Patients With Obesity and Metabolic Syndrome

NCT05891834CompletedPhase 2
Inversago Pharma Inc.
Posted 9/8/2023

Phase 2 Study of INV-202 in Patients With Diabetic Kidney Disease

NCT05514548CompletedPhase 2
Inversago Pharma Inc.
Posted 10/19/2022

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

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