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Clinical Trial News

Empagliflozin Safe and Effective Post-Heart Attack, Providing Kidney Protection

  • Empagliflozin demonstrates kidney-protective benefits in patients hospitalized for acute myocardial infarction (MI), according to a Mount Sinai-led study.
  • The EMPACT-MI trial showed empagliflozin reduces heart failure events post-heart attack, irrespective of the patient's baseline kidney function.
  • The study alleviates concerns about initiating SGLT2 inhibitors post-MI, showing empagliflozin is safe regarding kidney function in this setting.
  • Empagliflozin stabilizes eGFR (estimated glomerular filtration rate) in MI patients, indicating a protective effect on kidney function over time.

EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)

NCT04509674CompletedPhase 3
Boehringer Ingelheim
Posted 12/16/2020

Ixekizumab Shows Sustained Efficacy in Treating Psoriasis in Challenging Body Areas Over 5 Years

  • A 5-year study found ixekizumab maintains effectiveness in treating psoriasis in areas like the scalp, face, palms, soles, and nails.
  • Patients with psoriasis in challenging areas achieved similar PASI 100 responses compared to those without, indicating consistent drug performance.
  • Nail involvement showed a significant difference in cumulative clinical benefit, suggesting ixekizumab's particular effectiveness in this area.
  • The findings support ixekizumab as a reliable long-term treatment option for moderate to severe psoriasis, even in difficult-to-treat locations.

Abata Therapeutics' ABA-101 Treg Therapy Receives FDA Fast Track Designation for Progressive Multiple Sclerosis

• Abata Therapeutics' ABA-101, an autologous regulatory T-cell (Treg) therapy, has been granted Fast Track designation by the FDA for progressive multiple sclerosis (MS). • ABA-101 has demonstrated a tolerable safety profile and therapeutic effect in animal models, showing antigen-dependent Treg functionality and anti-inflammatory cytokine production. • The therapy targets progressive MS patients with imaging evidence of ongoing inflammatory tissue injury who are HLA-DRB1*15:01 positive, representing approximately 45,000 individuals in the U.S. • A Phase 1 study is planned to evaluate ABA-101's impact, addressing the critical need for effective treatments for progressive MS, where limited options currently exist.

FDA Grants Fast Track Designation to BGB-16673 for Relapsed/Refractory CLL/SLL

  • BGB-16673, an oral BTK-targeting chimeric degradation activation compound, has received FDA Fast Track designation for relapsed/refractory CLL/SLL.
  • The designation is based on data from a phase 1/2 study (NCT05006716) evaluating BGB-16673 in B-cell malignancies.
  • BGB-16673 may be eligible for accelerated approval and priority review, potentially offering a new treatment option for patients progressing after BTK inhibitors.

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716RecruitingPhase 1
BeiGene
Posted 9/13/2021

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

NCT02454972CompletedPhase 2
PharmaMar
Posted 8/25/2015

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

NCT05060016Active, Not RecruitingPhase 2
Amgen
Posted 12/1/2021

Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus CAV or Topotecan as Treatment in Patients With Small-Cell Lung Cancer

NCT02566993CompletedPhase 3
PharmaMar
Posted 8/30/2016

Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies

NCT04277637Active, Not RecruitingPhase 1
BeiGene
Posted 3/24/2020

Aficamten Shows Long-Term Safety and Cardiac Benefits in HCM Patients

  • Integrated safety analysis of aficamten across three clinical trials reinforces its robust safety profile, with adverse events similar to placebo.
  • FOREST-HCM analysis demonstrates successful withdrawal of standard of care medications in obstructive HCM patients treated with aficamten.
  • SEQUOIA-HCM data shows aficamten improves cardiac remodeling, structure, function, and biomarkers, suggesting potential disease modification.
  • Aficamten significantly improves symptom burden and quality of life in patients with obstructive HCM, as measured by KCCQ-OSS and SAQ-SS.

Ozempic Shows Promise in Reducing Heart Failure Risk in Diabetes Patients with Chronic Kidney Disease

  • Semaglutide, the active ingredient in Ozempic, demonstrates a 27% reduction in heart failure events among diabetes patients with chronic kidney disease.
  • The study also found a 29% decrease in the risk of cardiovascular death in the same patient population treated with semaglutide.
  • These findings from the FLOW trial highlight the potential of Ozempic to address heart disease, a leading cause of death, in vulnerable patients.
  • Further research is needed to understand the mechanisms behind semaglutide's cardioprotective effects in this specific patient group.

RHEIA Trial: TAVI Superior to Surgery for Aortic Stenosis in Women

  • The RHEIA trial demonstrated that transcatheter aortic valve implantation (TAVI) is superior to surgical aortic valve replacement in women with severe aortic stenosis.
  • TAVI significantly reduced the composite endpoint of all-cause mortality, stroke, and rehospitalization compared to surgery at one year.
  • The primary driver for TAVI's superiority was a notable reduction in rehospitalizations for valve-related symptoms or worsening heart failure.
  • TAVI was associated with shorter hospital stays and lower rates of new-onset atrial fibrillation, suggesting it could be the preferred therapy for women with severe aortic stenosis.

Mindfulness Training Shows Promise in Managing Chronic Pain: LAMP Trial Results

  • The LAMP pragmatic clinical trial evaluated the effectiveness of mindfulness training for chronic pain management.
  • The study compared two different approaches to mindfulness training in a multisite trial.
  • Results from the LAMP trial, presented by Dr. Diana Burgess, offer insights into non-pharmacological pain management strategies.
  • The findings contribute to the growing body of evidence supporting mindfulness-based interventions for chronic pain.

RAS Inhibitors: No Clear Advantage to Stopping or Continuing Before Noncardiac Surgery

  • The Stop-or-Not trial found no significant difference in death or major complications at 28 days between continuing or discontinuing RAS inhibitors before noncardiac surgery.
  • Intra-operative hypotension was more frequent with continued RAS inhibitors, but did not translate to increased serious complications.
  • Experts suggest individualizing care based on patient factors, hemodynamics, and the specifics of the surgery, offering clinicians greater flexibility.
  • Current guidelines weakly suggest either strategy is reasonable, highlighting the need for more research, especially in heart failure patients.

Aggressive Supportive Care May Reduce Infection Risk Following Linvoseltamab Treatment in Multiple Myeloma

  • Aggressive supportive care is crucial following linvoseltamab and BCMA bispecific antibody treatments to prevent high-grade infections, especially in community settings.
  • Intravenous immunoglobulin and infection prophylaxis are essential components of supportive care to mitigate the risk of severe infections post-immunotherapy.
  • Reducing the dosing frequency of bispecific antibodies, as seen with teclistamab, may also decrease the risk of infections over time.
  • Phase 1/2 LINKER-MM1 trial data highlights the efficacy of linvoseltamab but also underscores the importance of managing treatment-related infection incidence.

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04557098Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 9/17/2020

Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/23/2019

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