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Clinical Trial News

Novo Nordisk's Amycretin Shows Promising Weight Loss in Phase I Trial

  • Novo Nordisk's oral amycretin demonstrated significant weight loss, up to 13.1% in 12 weeks, in an early-stage trial.
  • The Phase I trial indicated that amycretin has a safety profile comparable to other incretin-based therapies, with mainly gastrointestinal side effects.
  • Amycretin targets both GLP-1 and amylin hormones, potentially offering a dual mechanism for appetite regulation and weight management.
  • Further clinical development is warranted, with a decision on skipping Phase II trials pending data from a subcutaneous version study.

Skyhawk's SKY-0515 Shows Promise in Huntington's Disease with 72% HTT mRNA Reduction

  • Skyhawk Therapeutics' SKY-0515 demonstrated a 72% average reduction in huntingtin (HTT) mRNA at a 9mg daily oral dose in healthy volunteers.
  • The Phase 1 clinical trial of SKY-0515 showed the drug was generally well tolerated across all tested doses in Parts A and B.
  • Part C of the Phase 1 trial, now enrolling patients with early-stage Huntington's disease, anticipates topline data in Q2 2025.
  • SKY-0515 is a novel small molecule designed to reduce both HTT and PMS1 proteins, key drivers of Huntington's disease.

TLX250-CDx Shows High Accuracy in Kidney Cancer Imaging: Phase 3 ZIRCON Trial Published

  • The Phase 3 ZIRCON trial results, published in The Lancet Oncology, demonstrate the high accuracy of TLX250-CDx in detecting clear cell renal cell carcinoma (ccRCC).
  • TLX250-CDx, a PET imaging agent, offers a non-invasive method for characterizing indeterminate renal masses, potentially reducing unnecessary surgeries.
  • The trial's findings support TLX250-CDx as a breakthrough technology for early and accurate diagnosis of kidney cancer, informing patient management and treatment decisions.
  • Telix is working to resubmit the BLA for TLX250-CDx to the FDA, targeting a commercial launch in 2025, which could make it the first targeted PET agent for kidney cancer.

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

NCT03849118CompletedPhase 3
Telix Pharmaceuticals (Innovations) Pty Limited
Posted 8/15/2019

Dexamethasone Prophylaxis Reduces Infusion-Related Reactions with Amivantamab in EGFR-Mutated NSCLC

  • A Phase 2 study (SKIPPirr) showed that prophylactic dexamethasone (8 mg) significantly reduced infusion-related reactions (IRRs) in NSCLC patients treated with intravenous amivantamab.
  • The IRR rate decreased to 22.5% with the dexamethasone regimen, a three-fold reduction compared to the 67.4% historically observed with standard IRR management.
  • The study suggests that a simple, accessible approach using dexamethasone pre-treatment can improve the patient experience with amivantamab and lazertinib combination therapy.
  • The observed safety profile of amivantamab and lazertinib with prophylactic dexamethasone was consistent with previous studies, with mostly Grade 1 or 2 IRR events.

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023

Walgreens Expands Clinical Trial Capabilities, Focusing on Diversity and Accessibility

  • Walgreens is leveraging its pharmacy network to enhance patient recruitment and real-world evidence services for biopharma, emphasizing improved access and representation in clinical trials.
  • The company's clinical trial business model centers on insights-driven patient recruitment, flexible trial conduct options (in-store, hybrid, at-home), and real-world evidence informatics.
  • Walgreens is actively working across various therapeutic areas, including diagnostic screenings for lung and colon cancer, diabetes, cardiovascular outcomes, and vaccination programs.
  • Strategic partnerships, including collaborations with BARDA and Boehringer Ingelheim, are aimed at decentralizing clinical trials and reaching underserved communities, highlighting Walgreens' commitment to inclusive research.

PALOMA-3 Study: Patient Satisfaction and Resource Utilization in NSCLC

  • The PALOMA-3 study (NCT05388669) evaluated patient satisfaction and resource utilization in patients with non-small cell lung cancer (NSCLC).
  • Results indicated notable patient satisfaction and efficient resource use, highlighting the potential for improved patient-centered care.
  • Dr. Natasha Leighl emphasized the importance of these findings for optimizing treatment strategies and healthcare delivery in NSCLC management.

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

Avistone's c-MET and EGFR Inhibitor Combination Shows Promise in NSCLC

  • Avistone Biotechnology announced positive results from a clinical research program combining vebreltinib and PLB1004 in NSCLC patients at WCLC 2024.
  • The combination therapy demonstrated an objective response rate (ORR) of 59.4% in response-evaluable patients with EGFR-mutated NSCLC with MET amplification or overexpression.
  • Notably, the ORR was 75.0% in patients with brain metastases and 58.6% in those who had previously received a third-generation EGFR-TKI.
  • The most common treatment-related adverse events (TRAEs) were rash and paronychia, with no treatment discontinuations due to TRAEs reported.

Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI

NCT06343064RecruitingPhase 1
Avistone Biotechnology Co., Ltd.
Posted 6/13/2023

Orforglipron Shows Promise in Reducing Cardiovascular and Inflammatory Markers in Phase II Trial

  • Eli Lilly's orforglipron, a novel oral GLP-1R agonist, demonstrates potential in reducing cardiovascular risk factors in obese patients without type 2 diabetes.
  • Phase II trial results reveal significant reductions in hsCRP (up to 41.9%), IL-6, leptin, and apolipoprotein B (apoB) levels with orforglipron treatment.
  • Orforglipron's efficacy in reducing systolic blood pressure suggests potential benefits beyond weight loss, though further studies in non-obese populations are needed.
  • The oral administration of orforglipron could offer advantages over injectable GLP-1R agonists, potentially reducing medication costs and improving patient compliance.

A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

NCT05048719CompletedPhase 2
Eli Lilly and Company
Posted 9/15/2021

Dexamethasone Significantly Reduces Infusion-Related Reactions with Amivantamab in EGFR-Mutated NSCLC

  • A Phase 2 study showed that dexamethasone prophylaxis significantly reduced infusion-related reactions (IRRs) in patients with EGFR-mutated NSCLC treated with intravenous amivantamab.
  • The SKIPPirr study demonstrated a three-fold reduction in IRR incidence with dexamethasone pre-treatment compared to historical data using standard IRR management.
  • All infusion-related reactions observed in the study were Grade 1 or 2, with no hospitalizations or Grade 3 or higher events reported, indicating improved patient safety.
  • The safety profile of amivantamab and lazertinib with prophylactic dexamethasone was consistent with prior studies, suggesting the regimen is well-tolerated.

A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

NCT06532032Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/23/2024

A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

NCT04606381Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 11/10/2020

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure

NCT04988295Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/17/2021

A Study of Amivantamab and Capmatinib Combination Therapy in Unresectable Metastatic Non-small Cell Lung Cancer

NCT05488314Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/13/2022

A Study of Combination Therapy With Amivantamab and Cetrelimab in Participants With Metastatic Non-small Cell Lung Cancer

NCT05908734RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/18/2023

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428RecruitingPhase 2
Janssen Research & Development, LLC
Posted 11/11/2022

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866Active, Not RecruitingPhase 2
Janssen Research & Development, LLC
Posted 5/18/2023

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

NCT04077463Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 9/4/2019

Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

NCT02609776Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 5/24/2016

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

NCT05379595RecruitingPhase 1
Janssen Research & Development, LLC
Posted 7/29/2022

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/Metastatic Head and Neck Cancer

NCT06385080RecruitingPhase 1
Janssen Research & Development, LLC
Posted 4/22/2024

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

September 2024: FDA Actions Span Diabetes, Neurology, and Rare Diseases

  • The FDA approved Embecta's tubeless patch pump for insulin delivery in adults with type 1 and type 2 diabetes, offering a 300-unit reservoir based on patient feedback.
  • Sparsentan (Filspari) received full FDA approval to slow kidney function decline in adults with primary IgA nephropathy (IgAN), based on positive Phase 3 PROTECT study data.
  • Approvals for arimoclomol (Miplyffa) and levacetylleucine (Aqneursa) mark the first specific treatments for neurological symptoms of Niemann-Pick disease type C (NPC).
  • Dupilumab (Dupixent) gained approval for COPD, chronic rhinosinusitis with nasal polyps, and was submitted for label expansion for adult growth hormone deficiency.

Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke

NCT04950920CompletedPhase 3
Peking University Third Hospital
Posted 6/28/2021

MEK Inhibitor Mirdametinib (PD-0325901) in Patients With Neurofibromatosis Type 1 Associated Plexiform Neurofibromas

NCT03962543Active, Not RecruitingPhase 2
SpringWorks Therapeutics, Inc.
Posted 9/29/2019

A Pivotal Study of N-Acetyl-L-Leucine on Niemann-Pick Disease Type C

NCT05163288RecruitingPhase 3
IntraBio Inc
Posted 6/30/2022

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