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SS Innovations Advances SSi Mantra Surgical Robot Toward FDA Approval

  • SS Innovations is pursuing FDA approval for its SSi Mantra Surgical Robotic System, aiming to provide affordable robotic surgery options.
  • The company completed a pre-submission meeting with the FDA, receiving feedback on regulatory strategy and clinical data requirements.
  • SS Innovations plans to submit an IDE application in Q1 2025 and anticipates potential pre-market approvals by the end of 2025.
  • Clinical trials will be conducted for various indications, leveraging existing data from India and planned trials in the United States.

BOTOX® Cosmetic Approved in China for Masseter Muscle Prominence

  • Allergan Aesthetics' BOTOX® Cosmetic (onabotulinumtoxinA) is now available in China for treating masseter muscle prominence (MMP) in adults.
  • The approval marks BOTOX® Cosmetic as the first neurotoxin approved in China for MMP, a significant aesthetic concern in the region.
  • Clinical trials demonstrated BOTOX® Cosmetic's effectiveness in reducing facial width by an average of 5.2mm compared to placebo, with effects lasting 6-9 months.
  • Allergan Aesthetics plans to pursue further development and approvals for onabotulinumtoxinA in treating MMP in other global markets.

Nuance Pharma Completes Phase 3 Trial Recruitment of Ensifentrine for COPD in China

  • Nuance Pharma has completed patient recruitment for the ENHANCE-CHINA phase 3 trial evaluating ensifentrine for COPD maintenance treatment.
  • The trial assesses the efficacy and safety of ensifentrine over 24 weeks in adult patients with moderate to severe COPD across 46 hospitals in China.
  • Ensifentrine, a first-in-class PDE3/PDE4 dual inhibitor, combines bronchodilator and anti-inflammatory effects in a single molecule.
  • The completion of recruitment sets the stage for results in 2025, potentially offering a new treatment option for COPD patients in China.

A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT05743075CompletedPhase 3
Nuance Pharma (shanghai) Co., Ltd
Posted 3/10/2023

TOFIDENCE Biosimilar Shows Sustained Efficacy and Safety in Rheumatoid Arthritis

  • Phase 3 trial data confirms TOFIDENCE (BAT1806/BIIB800) maintains comparable clinical efficacy and safety after switching from reference tocilizumab in rheumatoid arthritis patients.
  • The study evaluated ACR20/50/70 response and DAS28 change, demonstrating consistent outcomes between the TOFIDENCE and tocilizumab groups over 48 weeks.
  • Immunogenicity and pharmacokinetic profiles remained similar after switching, alleviating concerns about long-term safety and efficacy of TOFIDENCE.
  • The findings support TOFIDENCE as a biosimilar to tocilizumab for treating active rheumatoid arthritis in patients with inadequate response to methotrexate.

Viridian Therapeutics' Veligrotug Shows Promise in Phase III Thyroid Eye Disease Trial

  • Viridian Therapeutics' VRDN-001 (veligrotug) demonstrated satisfactory efficacy and safety in a Phase III THRIVE study for thyroid eye disease (TED).
  • The trial results suggest veligrotug could gain a moderate market share from Tepezza, with potential annual sales between $500 million and $700 million.
  • B.Riley increased Viridian's price target to $22.00, reflecting confidence in veligrotug's potential and the company's financial stability.
  • Viridian is advancing its TED treatments with ongoing Phase 3 trials for VRDN-001 and VRDN-003, supported by a strong cash position.

Ugandan Scientist Partners with TU Braunschweig to Develop East Coast Fever Vaccine

  • Dr. Charles Ndawula is collaborating with TU Braunschweig to research vaccines against East Coast Fever, a tick-borne disease affecting livestock.
  • The research focuses on identifying proteins in tick saliva and the parasite Theileria parva that can trigger an immune response in cattle.
  • Two approaches are being explored: targeting tick proteins recognized by the cattle's immune system and identifying parasite proteins for vaccine development.
  • The collaborative project aims to identify a vaccine candidate against East Coast Fever by 2027, potentially mitigating significant economic damage to agriculture.

Agios' Tebapivat Receives FDA Orphan Drug Designation for Myelodysplastic Syndromes

  • Agios Pharmaceuticals' tebapivat (AG-946) has been granted FDA orphan drug designation for treating myelodysplastic syndromes (MDS).
  • The designation provides incentives like tax credits and potential market exclusivity for rare disease treatments.
  • Tebapivat aims to be the first oral therapy for anemia in lower-risk MDS, affecting 75,000-80,000 patients in the U.S. and EU5.
  • Agios has completed a Phase 2a study and is initiating a Phase 2b study of tebapivat in lower-risk MDS.

A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)

NCT05490446RecruitingPhase 2
Agios Pharmaceuticals, Inc.
Posted 11/7/2022

Dupixent Shows Promise in Phase 3 Trial for Chronic Spontaneous Urticaria

  • Dupixent met primary and key secondary endpoints in a Phase 3 trial for chronic spontaneous urticaria (CSU) patients uncontrolled on antihistamines.
  • The LIBERTY-CUPID Study C demonstrated a nearly 50% reduction in itch and urticaria activity scores compared to placebo.
  • Sanofi and Regeneron plan to resubmit data to the FDA, potentially making Dupixent the first targeted CSU therapy in a decade if approved.

Viridian Therapeutics' Veligrotug Achieves Positive Phase III Results in Thyroid Eye Disease

  • Viridian Therapeutics' veligrotug met all primary and secondary endpoints in the Phase III THRIVE trial for active thyroid eye disease (TED).
  • The trial demonstrated statistically significant improvements in signs and symptoms of TED after 15 weeks of veligrotug treatment compared to placebo.
  • Veligrotug showed a rapid onset of action, with a favorable safety profile and no treatment-related serious adverse events reported.
  • Viridian plans to submit a biologics license application to the FDA in H2 2025, with topline data from the THRIVE-2 study expected by the end of this year.

An Efficacy, Safety, and Tolerability Study of Veligrotug (VRDN-001), in Participants With Chronic Thyroid Eye Disease (TED) (THRIVE-2)

NCT06021054Active, Not RecruitingPhase 3
Viridian Therapeutics, Inc.
Posted 11/14/2023

A Safety, Tolerability and Efficacy Study of VRDN 001 in Healthy Volunteers and Persons With Thyroid Eye Disease (TED)

NCT05176639Active, Not RecruitingPhase 3
Viridian Therapeutics, Inc.
Posted 12/3/2021

Arch Biopartners' LSALT Peptide Phase II Trial Approved for Cardiac Surgery-Associated Acute Kidney Injury

  • Arch Biopartners has received approval from Alberta Health Services for a Phase II trial of LSALT peptide in cardiac surgery-associated acute kidney injury (CS-AKI).
  • The trial is a multi-center, randomized, double-blind, placebo-controlled study with a target recruitment of 240 patients across multiple sites.
  • LSALT peptide targets the DPEP1 pathway and has shown promise in preclinical models for preventing ischemia-reperfusion injury to the kidneys.
  • CS-AKI is a common and serious complication following cardiac surgery, with prevalence up to 30% and associated with increased morbidity and mortality.

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