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Clinical Trial News

Verastem Oncology Announces Positive Interim Results and FDA Submission for Cancer Therapies

  • Verastem Oncology reported an 83% overall response rate in a Phase 1/2 trial of avutometinib plus defactinib with chemotherapy for metastatic pancreatic cancer.
  • The company initiated a rolling NDA submission to the FDA for avutometinib and defactinib in recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC).
  • A Phase 3 trial is underway comparing the combination therapy to standard chemotherapy or hormonal therapy for recurrent LGSOC.

FDA Expands Approval for GSK's Arexvy RSV Vaccine to Adults Aged 50-59 at Increased Risk

  • The FDA has approved GSK's Arexvy vaccine for adults aged 50-59 at increased risk of RSV, making it the first RSV vaccine for this population.
  • This approval is based on Phase III trial data demonstrating non-inferior immune responses in the 50-59 age group compared to those 60 and older.
  • Approximately 13 million adults in the U.S. aged 50-59 with underlying conditions such as COPD, asthma, heart failure, and diabetes could benefit.
  • Regulatory applications for Arexvy's label expansion are under review in the EU, Japan, and other countries, with trials ongoing for adults aged 18-49.

FDA Approves Moderna's mResvia, Third RSV Vaccine for Older Adults

  • The FDA has approved Moderna's mResvia vaccine for the prevention of RSV in adults aged 60 and older, making it the third approved RSV vaccine.
  • mResvia, like Moderna's COVID-19 vaccine, utilizes mRNA technology to target the prefusion F protein of RSV, offering a prefilled syringe for easier administration.
  • Moderna anticipates the RSV vaccine market to reach $6-8 billion in annual sales, with mResvia potentially gaining market share based on efficacy and ease of use.
  • Clinical trials showed mResvia to be approximately 84% effective against RSV-related disease with two or more symptoms, with effectiveness waning to 63% after 8.6 months.

Hormonal Gel Shows Promise in Phase 2 Trial for Male Contraception

  • A phase 2 trial of a novel hormonal gel containing testosterone and Nestorone demonstrated 86% sperm suppression in men after 12 weeks of daily application.
  • The gel's faster-than-expected action, achieving effective contraception in approximately eight weeks, is attributed to the combination of testosterone and Nestorone.
  • Researchers are now evaluating the gel's efficacy in preventing pregnancy within committed, monogamous relationships, with couples using it as their sole contraceptive method.
  • Several non-hormonal male contraceptive options are also in development, including pills and injectable gels, addressing the growing demand for diverse birth control choices.

Study Reveals Impact of Cholesterol Changes on Cardiovascular Disease Risk

A recent analysis of the PROMINENT trial and the Copenhagen General Population Study highlights the effects of changes in remnant cholesterol, LDL cholesterol, and apolipoprotein B on the risk of atherosclerotic cardiovascular disease, showing neutral outcomes despite significant lipid alterations.

Novel Alzheimer's Therapies Show Promise in Slowing Disease Progression

  • Remternetug demonstrates potential for faster amyloid clearance compared to existing immunotherapies, with ongoing Phase 3 trials evaluating subcutaneous administration.
  • Buntanetap shows early promise in improving memory and reducing tau protein levels, with plans for a larger Phase 3 trial to confirm efficacy in early-stage Alzheimer's.
  • Semaglutide, typically used for diabetes and weight loss, is under investigation for its potential to improve insulin sensitivity in the brain and slow Alzheimer's progression.
  • These drugs are currently experimental and not yet available on the NHS, pending regulatory approval and cost-effectiveness evaluations.

MoonLake Immunotherapeutics Initiates Phase 3 VELA Program for Sonelokimab in Hidradenitis Suppurativa

  • MoonLake Immunotherapeutics has commenced its Phase 3 VELA program to evaluate sonelokimab for moderate-to-severe hidradenitis suppurativa (HS).
  • The VELA program consists of two identical trials, VELA-1 and VELA-2, enrolling 800 patients to assess the efficacy and safety of sonelokimab 120mg versus placebo.
  • The primary endpoint for the VELA program is HiSCR75 at week 16, with topline results expected by mid-2025, potentially offering a new treatment option for HS patients.
  • Sonelokimab, a Nanobody®, targets IL-17A/A, IL-17A/F, and IL-17F/F dimers, aiming to provide a more effective treatment for this debilitating chronic skin condition.

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

NCT05640245CompletedPhase 2
MoonLake Immunotherapeutics AG
Posted 12/13/2022

A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis

NCT03384745CompletedPhase 2
Bond Avillion 2 Development LP
Posted 7/31/2018

A Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

NCT06411899Active, Not RecruitingPhase 3
MoonLake Immunotherapeutics AG
Posted 5/15/2024

Evaluation of Sonelokimab for the Treatment of Patients With Active Moderate to Severe Hidradenitis Suppurativa

NCT05322473CompletedPhase 2
MoonLake Immunotherapeutics AG
Posted 4/25/2022

Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

NCT06411379Active, Not RecruitingPhase 3
MoonLake Immunotherapeutics AG
Posted 5/14/2024

Upadacitinib Outperforms Dupilumab in Landmark LEVEL UP Trial for Moderate-to-Severe Atopic Dermatitis

  • The phase 3b/4 LEVEL UP trial demonstrated upadacitinib's superior efficacy over dupilumab, with 19.9% versus 8.9% of patients achieving both EASI 90 and minimal itch at week 16 (P<.0001).
  • While treatment-emergent adverse events were more common with upadacitinib (65.3% vs 52.7%), rates of severe adverse events and treatment discontinuations remained comparable between both therapies.
  • Principal investigator Dr. Jonathan Silverberg emphasized these findings provide important context for clinical decision-making, highlighting upadacitinib's ability to address unmet needs in atopic dermatitis treatment.

Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)

NCT03569293Active, Not RecruitingPhase 3
AbbVie
Posted 8/13/2018

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy

NCT02365649CompletedPhase 2
AbbVie
Posted 3/17/2015

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

NCT03607422Active, Not RecruitingPhase 3
AbbVie
Posted 7/27/2018

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

NCT02629159Active, Not RecruitingPhase 3
AbbVie
Posted 12/1/2015

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

NCT05843643RecruitingPhase 3
AbbVie
Posted 7/19/2023

A Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

NCT05889182RecruitingPhase 3
AbbVie
Posted 6/21/2023

A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)

NCT02819635CompletedPhase 2
AbbVie
Posted 9/26/2016

A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

NCT04169373CompletedPhase 3
AbbVie
Posted 11/26/2019

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

NCT05601882CompletedPhase 3
AbbVie
Posted 11/28/2022

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

NCT03104400CompletedPhase 3
AbbVie
Posted 4/27/2017

A study to assess adverse events and effectiveness of upadacitinib oral tablets in adult and adolescent participants with vitiligo.

2023-506195-27-00Active, Not RecruitingPhase 3
AbbVie Deutschland GmbH & Co. KG
Posted 12/19/2023

A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

NCT03568318Enrolling by InvitationPhase 3
AbbVie
Posted 8/9/2018

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

A Study to Evaluate the Efficacy and Safety of Upadacitinib in Participants With Takayasu Arteritis (TAK)

NCT04161898Active, Not RecruitingPhase 3
AbbVie
Posted 2/4/2020

A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis

NCT03725202CompletedPhase 3
AbbVie
Posted 2/6/2019

Moderna's Combination Flu-COVID Vaccine Shows Superior Immune Response in Phase 3 Trial

  • Moderna's mRNA-1083 combination vaccine demonstrated significantly higher immune responses against influenza strains and SARS-CoV-2 compared to standard vaccines in adults 50 years and older.
  • The Phase 3 trial met all primary endpoints with particularly strong results in adults 65+ where the combination vaccine outperformed Fluzone HD for influenza and Spikevax for COVID-19 protection.
  • The vaccine showed an acceptable safety profile with mostly mild to moderate side effects, positioning Moderna as the first company with positive Phase 3 data for a combination respiratory vaccine.

A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

NCT06097273CompletedPhase 3
ModernaTX, Inc.
Posted 10/19/2023

A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19

NCT05815498CompletedPhase 3
ModernaTX, Inc.
Posted 3/28/2023

Leqembi's Slow Adoption: Challenges and Progress in Alzheimer's Treatment

Monoclonal AntibodyDrug ApprovalNeurology
  • Leqembi, the first FDA-approved drug shown to slow Alzheimer's progression, has experienced slower-than-expected adoption despite its groundbreaking status in treating the disease.
  • Healthcare systems face significant implementation challenges, including establishing diagnostic protocols, monitoring systems for side effects, and navigating complex insurance coverage issues for the $26,000-per-year treatment.
  • Despite modest clinical benefits and potential side effects like brain swelling and bleeding, some patients report improvements in short-term memory, offering hope as researchers continue developing easier administration methods and complementary treatments.

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