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Clinical Trial News

Abemaciclib Monotherapy Fails to Show Efficacy in Advanced Renal Cell Carcinoma

  • A phase 1b trial of abemaciclib monotherapy in heavily pretreated metastatic clear cell renal cell carcinoma (ccRCC) patients showed no objective responses.
  • The study, involving 11 patients, reported a median progression-free survival of 1.8 months and a median overall survival of 9.1 months with abemaciclib.
  • Despite the lack of efficacy, the trial provides crucial context for interpreting future combination trials involving CDK4/6 inhibitors in RCC.
  • The findings highlight the need for novel targets and combination therapies to improve outcomes for patients with advanced RCC.

ABEMA Alone or in COMBO With MK-6482

NCT04627064CompletedPhase 1
Dana-Farber Cancer Institute
Posted 12/31/2020

Obicetrapib Shows Promise in Reducing LDL and Lp(a) Levels for Dyslipidemia Treatment

  • Obicetrapib has demonstrated significant potential in reducing low-density lipoprotein (LDL) levels in Phase II trials, both as a monotherapy and in combination therapy.
  • The completion of the Phase III TANDEM trial enrollment marks a crucial step towards a new treatment option for heterozygous familial hypercholesterolemia (HeFH) and atherosclerotic cardiovascular disease (ASCVD).
  • Obicetrapib has shown a 57% reduction in lipoprotein a [Lp(a)] levels, addressing a significant unmet need as current treatments like statins do not effectively lower Lp(a).
  • NewAmsterdam's obicetrapib is projected to be a leading agent in the dyslipidemia market, with estimated sales reaching $1.40 billion by 2032 across major markets.

Galapagos' ATALANTA-1 Clinical Trial for Hemophilia A to Expand to the US Following IND Clearance

  • Galapagos' ATALANTA-1 phase 1/2 clinical trial (NCT06561425) for hemophilia A is set to expand to the United States after receiving IND clearance.
  • The ATALANTA-1 trial is already ongoing in Europe and will now include US sites to further evaluate the safety and efficacy of their hemophilia A treatment.
  • Initial research indicates no FVIII-specific responses were associated with safety or efficacy parameters in over 100 hemophilia A patients.

A Study Evaluating the Safety and Efficacy of GLPG5101 (19CP02) in Participants With Non-Hodgkin Lymphoma

NCT06561425RecruitingPhase 1
Galapagos NV
Posted 3/9/2022

A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

NCT03758417RecruitingPhase 2
Nanjing Legend Biotech Co.
Posted 1/23/2019

European Study Reveals Harmful Impact of Delayed Myasthenia Gravis Diagnosis

  • A new European study finds patients with myasthenia gravis wait an average of 363 days for accurate diagnosis, with over 27% experiencing delays exceeding one year.
  • Patients with diagnostic delays over one year showed higher rates of MGFA class III disease, increased fatigue, anxiety, and depression compared to those diagnosed within a year.
  • The study spanning five European countries reveals 69.2% of patients with extended delays received incorrect initial diagnoses, highlighting urgent need for improved diagnostic strategies.

NXP800 Receives FDA Orphan Drug Designation for ARID1a-Deficient Ovarian Cancers

  • NXP800, a novel GCN2 kinase activator, has been granted orphan drug designation by the FDA for treating ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers.
  • The designation supports NXP800's potential in a subset of ovarian cancer, specifically those with ARID1a deficiency, validating its mechanism of action.
  • A phase 1b clinical trial is currently evaluating NXP800 in patients with platinum-resistant, ARID1a-mutated ovarian cancers to assess its safety and efficacy.
  • Preliminary data from the phase 1 trial supports the selection of 50 mg and 75 mg daily doses, showing biologically active exposure with acceptable safety.

A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer

NCT05226507RecruitingPhase 1
Nuvectis Pharma, Inc.
Posted 12/31/2021

Semaglutide Shows Promise for Long-Term Weight Loss, Dosage and Duration Key

  • A recent study indicates that semaglutide, known as Ozempic and Wegovy, is effective for long-term weight loss in obese patients.
  • Higher dosages and consistent use of semaglutide for over 90 days correlated with more successful weight loss outcomes.
  • Research suggests semaglutide increases metabolic activity, challenging the belief that it solely reduces food intake.
  • The FDA has declared a shortage of Wegovy due to increased demand, highlighting the drug's popularity and impact.

Semaglutide Shows Promise for Obesity-Related Heart Failure with Preserved Ejection Fraction

  • The SELECT trial evaluated semaglutide for treating obesity-related heart failure with preserved ejection fraction (HFpEF), showing promising results.
  • Semaglutide demonstrated efficacy in reducing body weight and cardiovascular risks in overweight or obese patients without diabetes.
  • The drug's impact on cardiovascular, metabolic, and kidney endpoints was consistent across sexes, suggesting broad applicability.
  • Semaglutide is poised to become a significant treatment option for HFpEF, addressing a long-standing unmet medical need.

NH130 Shows Promise in Phase I Trial for Parkinson's Disease Psychosis

  • NH130, a selective serotonin 5-HT2A inverse agonist, demonstrates favorable pharmacokinetics and safety in a Phase I trial for Parkinson's disease psychosis (PDP).
  • The single-dose escalation study involved healthy volunteers receiving varying doses of NH130, with no serious adverse events reported.
  • A physiologically based pharmacokinetic (PBPK) model accurately predicted clinical plasma concentrations, validating its utility for future clinical development.
  • These findings support further multi-dose trials of NH130, suggesting its potential as a therapeutic agent for managing PDP.

Phase 3 Trial Launched for Oral Cladribine in Generalized Myasthenia Gravis

  • Merck KGaA has initiated a Phase 3 clinical trial, MyClad, to evaluate the safety and efficacy of oral cladribine capsules for treating generalized myasthenia gravis (gMG).
  • The global, randomized, double-blind, placebo-controlled study will involve 240 participants and aims to assess cladribine's impact on this neurodegenerative condition.
  • Cladribine selectively targets B and T lymphocytes, which are believed to be the primary cause of gMG, offering a potential at-home treatment option to reduce patient burden.
  • The trial's progress could provide a new therapeutic option for gMG, addressing the challenges of nerve-muscle communication and improving patient outcomes.

CellProthera Advances ProtheraCytes Cell Therapy Program for Myocardial Infarction with FDA Alignment on Phase III Trial Design

  • CellProthera has secured FDA alignment on the design for a pivotal Phase III trial of ProtheraCytes, a cell therapy for acute myocardial infarction (AMI).
  • The Phase III trial will be conducted in the US and Europe, involving a larger patient cohort with a two-year follow-up to assess long-term efficacy.
  • ProtheraCytes showed improved left ventricular volumes and myocardial segment viability in the Phase II EXCELLENT study, indicating promising efficacy signals.
  • The planned Phase III trial will be a randomized, open-label study with standard-of-care post-AMI treatment as the control, focusing on a composite endpoint.
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