MedPath

Clinical Trial News

Novo Nordisk's Monlunabant Shows Weight Loss Potential in Phase 2a Obesity Trial

  • Novo Nordisk's monlunabant, a CB1 inverse agonist, demonstrated statistically significant weight loss compared to placebo in a Phase 2a trial for obesity and metabolic syndrome.
  • Participants on the lowest dose of monlunabant (10 mg) experienced a 7.1 kg weight loss versus 0.7 kg with placebo over 16 weeks, with limited additional benefit at higher doses.
  • The trial reported mostly mild to moderate gastrointestinal side effects, but also dose-dependent neuropsychiatric effects like anxiety and sleep disturbances.
  • A larger Phase 2b trial is planned for 2025 to further investigate dosing and safety of monlunabant in a global population.

Atezolizumab, Venetoclax, and Obinutuzumab Show Promise in Richter Transformation DLBCL

  • A phase II trial (MOLTO) demonstrated that atezolizumab, venetoclax, and obinutuzumab achieved a 67.9% objective response rate in patients with Richter transformation diffuse large B-cell lymphoma (DLBCL-RT).
  • After 12 months, progression-free survival was 42.9% overall, with 87.5% in patients achieving complete remission, highlighting the regimen's potential for durable responses.
  • The combination therapy showed a manageable safety profile, with neutropenia being the most common adverse event, and no treatment-related deaths were reported.

Alzheimer's Drugs Lecanemab and Donanemab Spark Controversy Despite Slowing Disease Progression

  • Lecanemab (Leqembi) and donanemab (Kisunla) are the first drugs to slow Alzheimer's progression, yet face controversy over their limited effectiveness and potential risks.
  • Clinical trials show these drugs reduce cognitive decline by approximately 30% in early-stage patients, but some experts argue the benefits are minimal compared to side effects.
  • The high cost of lecanemab and donanemab raises concerns about accessibility and equitable distribution, potentially creating disparities in treatment availability.
  • Despite the debate, many neurologists advocate for these drugs, emphasizing their potential to offer patients valuable additional months of autonomy, especially with earlier diagnosis.

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

NCT05269394Active, Not RecruitingPhase 2
Washington University School of Medicine
Posted 12/22/2021

A Study to Assess Safety and Target Engagement of E2814 in Participants With Mild to Moderate Cognitive Impairment Due to Dominantly Inherited Alzheimer's Disease

NCT04971733CompletedPhase 1
Eisai Inc.
Posted 6/28/2021

CHMP Recommends Daratumumab-Based Quadruplet Regimen for Newly Diagnosed Multiple Myeloma

  • The CHMP has recommended daratumumab subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for transplant-eligible multiple myeloma patients.
  • The recommendation is based on the Phase 3 PERSEUS study, which demonstrated a 60% reduction in disease progression or death risk with the D-VRd regimen.
  • Daratumumab, a CD38-directed antibody, has become a foundational therapy for multiple myeloma since its initial European approval in 2016.
  • The positive opinion supports the goal of establishing a new standard of care and transforming the treatment landscape for multiple myeloma.

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

NCT03710603Active, Not RecruitingPhase 3
Stichting European Myeloma Network
Posted 12/14/2018

LP-168, a Novel BTK Inhibitor, Shows Promise in Relapsed/Refractory Mantle Cell Lymphoma

  • LP-168, a highly selective next-generation BTK inhibitor, is under investigation in the phase 2 ROCK-1 trial for relapsed/refractory mantle cell lymphoma (MCL).
  • The ROCK-1 trial is an open-label, single-arm, multicenter study evaluating the safety and efficacy of LP-168 monotherapy in MCL patients who have previously been treated with a covalent BTK inhibitor.
  • LP-168 has high bioavailability and potency, acting as a covalent BTK inhibitor by irreversibly inhibiting BTK wild type and overcoming resistance of covalent BTK inhibitors.
  • The primary endpoint of the ROCK-1 study is objective response rate (ORR) per Lugano criteria, with secondary endpoints including safety, quality of life, and other efficacy parameters.

A Study of Rocbrutinib in Participants with Relapse or Refractory Mantle Cell Lymphoma

NCT05716087Active, Not RecruitingPhase 2
Guangzhou Lupeng Pharmaceutical Company LTD.
Posted 2/21/2023

FDA Approves Alpha Tau's IDE for Alpha DaRT Study in Immunocompromised cSCC Patients

  • Alpha Tau Medical's Investigational Device Exemption (IDE) has been approved by the FDA for a multi-center study of Alpha DaRT in immunocompromised patients with recurrent cutaneous Squamous Cell Carcinoma (cSCC).
  • The study, led by Emory University's Winship Cancer Institute, will enroll up to 28 patients across 8 U.S. institutions, focusing on those with weakened immune systems, excluding diabetes.
  • The primary objective is to determine the objective response rate (ORR), while secondary objectives include progression-free survival, overall survival, local control, and safety assessment.
  • This trial aims to provide a potential new treatment option for a vulnerable population with limited options, addressing the increased risk of cSCC in immunocompromised individuals.

Amgen's Strategic Growth Plan: Focus on Tepezza, MariTide, and Pipeline Expansion

  • Amgen's acquisition of Horizon Therapeutics for $28 billion brings Tepezza, a unique treatment for thyroid eye disease, poised for better market penetration with Amgen's backing.
  • MariTide, Amgen's investigational drug for weight loss and diabetes, shows promise with statistically significant weight loss in Phase 1 and potential for $2.1 billion revenue by 2030.
  • Amgen is advancing a diverse pipeline, including label expansions for Lumakras and Amjevita, biosimilars for drugs like Opdivo, and novel therapies like dazodalibep for Sjögren's syndrome.
  • With a solid dividend yield and strategic acquisitions, Amgen anticipates improved revenue growth driven by key products and pipeline advancements.

Biosyngen's Enhanced TIL Therapy Shows Promise in Liver Cancer Treatment

  • Biosyngen presented its next-generation tumor-infiltrating lymphocyte (TIL) technology at the ESMO 2024 Annual Congress, showcasing advancements in liver cancer treatment.
  • The company's proprietary platform expands TILs from biopsy samples, achieving significant cell production within four weeks, enhancing antitumor efficacy.
  • Biosyngen's gene-modified TILs demonstrate strong tumor-killing effects without requiring concomitant IL-2 use, addressing limitations of traditional TIL therapies.
  • BRG01, Biosyngen's lead product, is in a pivotal Phase II clinical trial for solid tumors, with Phase I trials for BST02 and BRL03 anticipated to complete this year.

CHMP Recommends Dupixent for Pediatric Eosinophilic Esophagitis in the EU

  • The European Medicines Agency's CHMP has recommended Dupixent (dupilumab) for treating eosinophilic esophagitis (EoE) in children aged 1-11 years in the EU.
  • The recommendation targets children weighing at least 15 kg who have not responded adequately to conventional therapies for their eosinophilic esophagitis.
  • The CHMP's positive opinion was based on the EoE KIDS Phase 3 trial, which demonstrated significant histological remission in children treated with Dupixent.
  • Dupixent, co-developed by Regeneron and Sanofi, is already approved in the EU for EoE in adults and adolescents aged 12 years and older.

Kangpu Biopharmaceuticals' KPG-818 Demonstrates Favorable Safety Profile in China Bridging Study

  • Kangpu Biopharmaceuticals completed a bridging clinical study of KPG-818 in healthy Chinese subjects, assessing safety, tolerability, and pharmacokinetics.
  • The randomized, double-blind, placebo-controlled trial evaluated multiple oral doses of KPG-818 over 14 days, with a 4-week follow-up period.
  • Results showed KPG-818 was well-tolerated, with no serious adverse events reported and close to linear pharmacokinetics observed across the tested dose range.
  • KPG-818, a CRBN E3 ubiquitin ligase complex modulator, previously demonstrated promising efficacy and safety in a Phase Ib/IIa study for SLE patients in the US.

Phase 1b/2a Study to Evaluate Safety and Efficacy of KPG-818 in SLE

NCT04643067CompletedPhase 1
Kangpu Biopharmaceuticals, Ltd.
Posted 6/3/2021

Trending News

1

FDA Approves Streamlined Access for Bristol Myers Squibb CAR T Cell Therapies

a day ago
2

Biogen Advances Salanersen to Phase 3 Studies for Spinal Muscular Atrophy After Promising Results

3 days ago
3

Vor Bio Secures Global Rights to Telitacicept in $4+ Billion Deal with RemeGen

2 days ago
4

UCB's Fenfluramine Achieves Positive Phase 3 Results in Ultra-Rare CDKL5 Deficiency Disorder

a day ago
5

Percheron Therapeutics Acquires Phase II-Ready Anti-VISTA Cancer Immunotherapy HMBD-002 in $290M Deal

2 days ago
6

China Approves First Once-Daily Nebulized LAMA for COPD, Triggering $7.5M Milestone for Theravance

2 days ago
7

ProFound Therapeutics Partners with Novartis in $775M Cardiovascular Drug Discovery Deal

2 days ago
8

QBiotics' Tigilanol Tiglate Achieves 80% Response Rate in Soft Tissue Sarcoma Phase IIa Trial

3 days ago
9

Lipocine Initiates Phase 3 Trial for Oral Brexanolone in Postpartum Depression

2 days ago
10

DBV Technologies Initiates COMFORT Toddlers Phase 3 Study for Viaskin Peanut Patch in Young Children

2 days ago
Subscribe Icon

Daily Pharma Insights

Get curated, high-impact pharmaceutical news delivered to your inbox every morning.

  • Critical clinical trial updates & results
  • Regulatory approvals & strategic partnerships
  • Market access decisions & commercial developments
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy