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MannKind's Clofazimine Inhalation Suspension Phase 3 Trial for NTM Lung Disease Cleared in Japan

  • MannKind's ICoN-1 Phase 3 trial of Clofazimine Inhalation Suspension for NTM lung disease has been cleared by Japan's PMDA, expanding the trial globally.
  • The ICoN-1 trial is a multinational, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of the drug in refractory NTM lung disease.
  • The trial, already underway in the U.S., aims to enroll approximately 230 participants across multiple sites to assess sputum culture conversion and quality of life.
  • Clofazimine Inhalation Suspension has received Fast Track, Orphan Drug, and QIDP designations from the FDA, potentially granting market exclusivity upon approval.

ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension

NCT06418711RecruitingPhase 3
Mannkind Corporation
Posted 9/11/2024

Invion's INV043 Shows Promise in Phase II Prostate Cancer Trial

  • Invion's INV043, a photodynamic technology, demonstrated a positive response in approximately 40% of participants in a Phase II prostate cancer trial.
  • The trial showed 10% of participants experienced complete regression based on RECIST 1.1 criteria, with mild side effects reported.
  • 44% of participants achieved negative PSMA-PET results three months post-treatment, suggesting potential efficacy in targeting prostate cancer.
  • A clinical study summary recommends further investigation of INV043 due to its favorable safety profile and promising preliminary efficacy results.

Emerging IL-17 Inhibitors Show Promise in Hidradenitis Suppurativa Treatment

  • Bimekizumab, an IL-17 A and F blocker, shows promising data for hidradenitis suppurativa (HS) treatment, offering a potential advancement in patient care.
  • Secukinumab, an anti-IL17A biologic drug, has recently been approved and demonstrates superiority versus placebo in clinical trials for HS.
  • Innovative nanobody delivery methods targeting IL-17 A and F are under development, potentially improving molecule penetration and treatment efficacy.
  • The approval of secukinumab and the development of other anti-IL-17 therapies signify a shift towards more effective HS treatments compared to adalimumab.

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

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

Keytruda Extends Cancer-Free Survival in High-Risk Bladder Cancer Patients Post-Surgery

  • Keytruda (pembrolizumab) significantly extends cancer-free survival in patients with high-risk, muscle-invasive bladder cancer after surgery, compared to observation.
  • Patients receiving post-operative Keytruda experienced nearly 30 months of cancer-free survival, doubling the 14 months observed in the monitoring-only group.
  • The benefit of Keytruda was more pronounced in patients with PD-L1-positive tumors, showing almost 37 months of cancer-free survival.
  • This trial supports Keytruda as a valuable post-surgical treatment option, especially for those who cannot tolerate cisplatin chemotherapy.

FDA Grants Fast Track Designation to ICT01 Plus Azacitidine and Venetoclax for AML

  • The FDA granted Fast Track designation to ICT01 plus azacitidine and venetoclax for acute myeloid leukemia (AML) treatment in patients unfit for standard induction chemotherapy.
  • ICT01, a humanized anti-BTN3A monoclonal antibody, selectively activates gamma-delta T cells and is under evaluation in the phase 1/2a EVICTION trial.
  • Interim phase 1 data showed a strong safety profile and a 30% disease control rate, leading to a randomized dose-optimization cohort in October 2023.
  • The Fast Track designation may allow ImCheck Therapeutics more frequent FDA meetings, priority review, and accelerated approval.

First-in-Human Study of ICT01 in Patients With Advanced Cancer

NCT04243499Active, Not RecruitingPhase 1
ImCheck Therapeutics
Posted 2/10/2020

Neoadjuvant Chemotherapy Shows Promise in Nasal and Paranasal Sinus Cancer

  • A phase 2 trial (EA3163) suggests neoadjuvant chemotherapy may improve organ preservation in T3/T4a NPNSCC patients.
  • Structural preservation rates trended higher with neoadjuvant chemotherapy compared to surgery alone, though not statistically significant.
  • The study faced challenges in enrollment, resulting in an underpowered analysis, but showed improved SP with neoadjuvant chemotherapy.
  • Overall survival data from the trial are still immature, with similar 2-year OS rates observed in both treatment arms.

Chemotherapy Before Surgery and Radiation Therapy or Surgery and Radiation Therapy Alone in Treating Patients With Nasal and Paranasal Sinus Cancer That Can Be Removed by Surgery

NCT03493425RecruitingPhase 2
ECOG-ACRIN Cancer Research Group
Posted 3/12/2019

Merit Medical's WRAPSODY Stent Graft Shows Promise in Dialysis Access

  • Merit Medical's WRAPSODY stent graft demonstrated an 89.9% target lesion primary patency rate at six months in dialysis patients with arteriovenous fistulas (AVF).
  • The WAVE trial compared WRAPSODY to percutaneous transluminal angioplasty (PTA), showing a 27% higher patency rate with the stent graft.
  • WRAPSODY's design includes a cell-impermeable stent graft with polytetrafluoroethylene layers to reduce thrombus formation and prevent stent migration.
  • The company is seeking FDA approval for commercial use based on the WAVE trial and previous first-in-human study results.

Nicox's ZERVIATE Approved in China for Allergic Conjunctivitis

  • Ocumension Therapeutics, Nicox's partner, has received approval in China to commercialize ZERVIATE for treating ocular itching linked to allergic conjunctivitis.
  • The approval of ZERVIATE marks the first cetirizine ophthalmic solution available in China, addressing a significant gap in treatment options for allergic conjunctivitis.
  • Nicox stands to gain a new revenue stream through royalties, ranging from 5% to 9% of Ocumension's net sales, along with potential sales milestones.
  • Ocumension plans to manufacture ZERVIATE locally and target peak annual sales exceeding $100 million within seven years, addressing a market expected to reach $500 million by 2030.

Fasenra Receives FDA Approval for Eosinophilic Granulomatosis with Polyangiitis

  • The FDA has approved AstraZeneca's Fasenra (benralizumab) for treating adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
  • The approval was based on the Phase III MANDARA trial, which demonstrated non-inferiority to mepolizumab in achieving remission.
  • Fasenra showed a significant proportion of patients could taper off oral corticosteroids, offering a crucial benefit.
  • This approval marks Fasenra as only the second biologic approved for EGPA, providing a new treatment option for this rare disease.

A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES)

NCT04191304Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/20/2020

Mepolizumab as Add-on Treatment IN Participants With COPD Characterized by Frequent Exacerbations and Eosinophil Level

NCT04133909CompletedPhase 3
GlaxoSmithKline
Posted 10/30/2019

Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations

NCT04053634Active, Not RecruitingPhase 3
AstraZeneca
Posted 8/26/2019

Efficacy and Safety Study of Benralizumab in Patient With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps (ORCHID)

NCT04157335CompletedPhase 3
AstraZeneca
Posted 11/25/2019

Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.

NCT04157348Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/29/2019

Sensorion's SENS-501 Shows Promise in Gene Therapy for OTOF-Related Hearing Loss

  • Sensorion's SENS-501 Audiogene trial treated its first patient, showing initial safety and behavioral changes, with cohort completion expected by year-end.
  • Final data from the SENS-401 Phase 2a trial indicates it preserves residual hearing after cochlear implantation, showing better outcomes at multiple frequencies.
  • Preliminary data from the SENS-401 NOTOXIS trial suggests a potential protective effect against Cisplatin-Induced Ototoxicity, especially at higher doses.
  • Sensorion's financial position is strong, with approximately €87 million in cash, supporting operations through the end of 2025.

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