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Clinical Trial News

Pfizer's Ponsegromab Shows Promise in Treating Cancer Cachexia in Phase 2 Trial

  • Pfizer's ponsegromab met its primary endpoint in a Phase 2 trial, demonstrating a significant increase in body weight compared to placebo in cancer patients with cachexia.
  • The highest dose of ponsegromab resulted in a 5.61% mean increase in body weight after 12 weeks, along with improvements in appetite, physical activity, and muscle mass.
  • The investigational monoclonal antibody targets GDF-15, a key driver of cachexia, and was generally safe and well-tolerated across all dose levels.
  • Pfizer plans to initiate registration-enabling studies in 2025 based on these positive results, potentially offering a new treatment option for this debilitating condition.

A Clinical Study of IMP4297 Capsule (JS109) Combined With Irinotecan in the Treatment of Advanced Malignant Solid Tumors

NCT05824455RecruitingPhase 1
Shanghai Jun Pai Ying Shi Therapeutics Co., Ltd.
Posted 3/23/2023

A Study of Ponsegromab in People With Heart Failure

NCT05492500TerminatedPhase 2
Pfizer
Posted 9/26/2022

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

NCT05546476CompletedPhase 2
Pfizer
Posted 11/21/2022

Combination of Pembrolizumab and Lenvatinib, in Pre-treated Thymic CArcinoma paTIents

NCT04710628Active, Not RecruitingPhase 2
MedSIR
Posted 9/21/2021

A Proof of Concept Study to Evaluate Exosomes From Human Mesenchymal Stem Cells in Women With Premature Ovarian Insufficiency (POI)

NCT06072794RecruitingPhase 1
Vitti Labs, LLC
Posted 10/6/2023

Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment

NCT05627245RecruitingPhase 1
National Cancer Institute (NCI)
Posted 3/1/2023

An Open-label Study to Define the Safety, Tolerability and Clinical Activity of Deutetrabenazine (AUstedo) in Adult Study Subjects With DYsTonia

NCT04173260Active, Not RecruitingPhase 1
University of Pennsylvania
Posted 4/29/2021

Intercept's Ocaliva Faces Setback as FDA Advisory Committee Recommends Against Full Approval for PBC

  • The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) has voted against full approval of Intercept's Ocaliva for primary biliary cholangitis (PBC).
  • The vote raises concerns about Ocaliva's clinical benefit as a second-line therapy for PBC patients, despite eight years of real-world patient experience.
  • Intercept remains committed to working with the FDA to address concerns and seek full approval for Ocaliva, with a PDUFA date set for October 15, 2024.
  • Ocaliva, a farnesoid X receptor (FXR) agonist, is currently approved under accelerated approval based on reduction in alkaline phosphatase (ALP).

ICMR Partners with Industry to Advance First-in-Human Phase 1 Clinical Trials in India

  • The Indian Council of Medical Research (ICMR) has signed agreements to advance first-in-human Phase 1 clinical trials for four molecules.
  • Collaborations include research for multiple myeloma, Zika vaccine development, influenza vaccine trials, and CAR-T cell therapy advancements.
  • This initiative aims to establish India as a leader in pharmaceutical clinical development and affordable healthcare solutions.
  • The ICMR network includes four institutions across India, enhancing the capacity for early-phase clinical trials with robust infrastructure.

Gut Microbiome Emerges as Key Player in Cancer Immunotherapy Response, New Research Shows

  • Recent research reveals specific bacterial networks in the gut microbiome can predict cancer patients' response to immunotherapy, with Akkermansia muciniphila and Faecalibacterium prausnitzii identified as beneficial species.
  • Broad-spectrum antibiotics significantly reduce survival rates in cancer patients undergoing immunotherapy, with a meta-analysis of 46,000 patients showing a 1.7-fold higher risk of reduced survival.
  • Novel interventions, including a specialized charcoal capsule and fecal microbiota transplantation, show promising results in preserving microbiome diversity and enhancing immunotherapy effectiveness in clinical trials.

Fecal Microbial Transplantation Non-Small Cell Lung Cancer and Melanoma

NCT04951583Active, Not RecruitingPhase 2
Centre hospitalier de l'Université de Montréal (CHUM)
Posted 11/16/2021

Maui Derm NP+PA Fall 2024 Conference to Spotlight Latest Advances in Dermatology Treatment

  • The four-day Maui Derm NP+PA Fall 2024 conference, scheduled for September 15-18 at Gaylord Opryland, will provide comprehensive updates on dermatological advances for nurse practitioners and physician assistants.
  • Leading experts will present sessions on crucial developments including new therapies for psoriasis, hidradenitis suppurativa management, and pediatric dermatology approaches.
  • The conference features interactive case discussions and survey-based participation, covering topics from blistering diseases to the latest pharmaceutical developments in dermatological care.

IO102-IO103 Cancer Vaccine Plus Pembrolizumab Shows Promise in Head and Neck Cancer

  • A phase 2 trial combining IO102-IO103 cancer vaccine with pembrolizumab demonstrated a 44.4% partial response rate in advanced squamous cell carcinoma of the head and neck (SCCHN).
  • The combination therapy's safety profile was consistent with pembrolizumab alone, with some injection site reactions, suggesting a manageable safety profile.
  • Early data indicate that the vaccine activates T cells against IDO-positive and PD-L1–positive cells, potentially enhancing the immune response in the tumor microenvironment.
  • These findings support further investigation in larger studies to confirm the efficacy and potential of IO102-IO103 plus pembrolizumab in SCCHN.

ESMO 2024: New Leadership and Groundbreaking Developments in Oncology Research and Patient Care

  • ESMO President Prof Andres Cervantes highlights the organization's evolution into a comprehensive support network for oncologists, announcing new initiatives including AI & Digital Oncology Congress 2025.
  • Significant advances in oncofertility research reveal pregnancy after breast cancer is feasible, leading to new fertility preservation laws and guidelines for cancer patients.
  • Whole Genome Sequencing emerges as a transformative tool in personalized cancer care, with Prof Serena Nik-Zainal demonstrating its potential for identifying unique mutational signatures in individual tumors.

Dermatology Experts Highlight Advances in Treatment and Clinical Trial Diversity

  • Experts at the Skin of Color Update 2024 emphasized the importance of diversity in clinical trials to address health disparities and improve data for all patient populations.
  • Recent FDA approvals of topical therapies like roflumilast and tapinarof for atopic dermatitis and other conditions were highlighted for their efficacy and safety.
  • Advances in biologic therapies, including bimekizumab, secukinumab, and nemolizumab, offer new treatment options for conditions like psoriasis, hidradenitis suppurativa and prurigo nodularis.
  • The FDA's Diversity Action Plan (DAP) aims to increase the enrollment of underrepresented groups in clinical trials, ensuring treatments are effective across diverse populations.

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3001)

NCT03956355CompletedPhase 3
Organon and Co
Posted 5/21/2019

A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03410992CompletedPhase 3
UCB Biopharma SRL
Posted 2/5/2018

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

NCT03713632CompletedPhase 3
Novartis Pharmaceuticals
Posted 2/25/2019

Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04211363CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 12/20/2019

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

NCT03713619CompletedPhase 3
Novartis Pharmaceuticals
Posted 1/31/2019

Tapinarof for the Treatment of Plaque Psoriasis in Adults (3002)

NCT03983980CompletedPhase 3
Organon and Co
Posted 6/6/2019

Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

NCT04973228CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 7/8/2021

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03412747CompletedPhase 3
UCB Biopharma SRL
Posted 1/26/2018

Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501666CompletedPhase 3
Galderma R&D
Posted 9/11/2020

Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

NCT04211389CompletedPhase 3
Arcutis Biotherapeutics, Inc.
Posted 12/17/2019

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

NCT04501679CompletedPhase 3
Galderma R&D
Posted 8/11/2020

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03370133CompletedPhase 3
UCB Biopharma SRL
Posted 12/6/2017

FDA Approves Kisunla (donanemab-azbt) for Early-Stage Alzheimer's Disease

  • The FDA has approved Kisunla (donanemab-azbt) for treating early-stage Alzheimer's, marking a significant advancement in disease management.
  • Kisunla, an amyloid-directed antibody, targets and helps remove amyloid plaques in the brain, which are believed to contribute to cognitive decline.
  • Clinical trials showed that a significant percentage of patients achieved undetectable amyloid plaque levels, allowing them to discontinue treatment.
  • Safety concerns include ARIA, a potential side effect requiring careful monitoring through MRI and symptom awareness.

Advancements in Ocular Therapies: Updates on Dry Eye, AMD, and Myopia Management

  • Aldeyra Therapeutics resubmitted its NDA for reproxalap, targeting dry eye disease symptoms with both acute and chronic activity demonstrated in trials.
  • Aviceda Therapeutics completed enrollment for its Phase 2b SIGLEC study, evaluating AVD-104 for geographic atrophy secondary to age-related macular degeneration.
  • Ocular Therapeutix accelerates the SOL-1 Phase 3 trial of Axpaxli for wet AMD, expecting topline data in Q4 2025.

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