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Clinical Trial News

African Scientists Lead the Charge in Global Drug Discovery with Focus on Tailored Treatments

  • African scientists are pioneering drug discovery, exemplified by the Holistic Drug Discovery and Development Centre (H3D) at the University of Cape Town.
  • MMV390048, the first small-molecule clinical candidate discovered by an Africa-led team, reached Phase 2 trials, marking a significant milestone.
  • Initiatives like Project Africa GRADIENT use AI to develop treatments tailored for diverse African populations, partnering with companies like GSK and Novartis.
  • Increased investment, such as the Grand Challenges African Drug Discovery Accelerator, signals growing confidence in African-led science and pan-African collaboration.

Telisotuzumab Vedotin Improves Patient-Reported Outcomes in c-Met+ NSCLC

  • The LUMINOSITY trial showed telisotuzumab vedotin (Teliso-V) yielded a 29% response rate in patients with c-Met-overexpressing, EGFR wild-type, nonsquamous NSCLC.
  • Patient-reported outcomes from LUMINOSITY indicated improvements in key cancer-related symptoms like cough and chest pain with Teliso-V treatment.
  • The trial also demonstrated that Teliso-V maintained quality of life and physical functioning, particularly in patients achieving disease control.
  • Peripheral neuropathy, a notable side effect, was reported by patients, highlighting the need for proactive management in subsequent trials.

Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer

NCT03539536Active, Not RecruitingPhase 2
AbbVie
Posted 10/10/2018

FDA Approves Dupixent for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

  • The FDA has expanded the approval of Dupixent (dupilumab) for adolescents aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
  • This approval marks the first biologic specifically indicated for adolescent CRSwNP, offering an alternative to the standard of care.
  • Dupixent's efficacy was demonstrated in Phase 3 trials (SINUS-24 and SINUS-52) showing improvements in nasal congestion, polyp size, and sense of smell.
  • Dupixent, developed by Regeneron and Sanofi, inhibits IL-4 and IL-13 pathways and is approved for multiple type 2 inflammatory diseases.

Loyal's Loy-002 Shows Promise in Extending Dog Lifespan in Phase 2 Trial

  • Loyal is conducting a Phase 2 clinical trial of Loy-002, a drug aimed at extending both the length and quality of life for aging dogs.
  • Early results from the trial indicate improved metabolic health in dogs, including better insulin sensitivity and muscle regulation.
  • Some participants have shown increased energy levels and physical activity, suggesting a potential reversal of aging effects.
  • The trial is ongoing, with hopes of future FDA approval to make the drug available for broader use in canines.

FDA Approves Biotronik's Left Bundle Branch Area Pacing System

  • The FDA has granted approval for Biotronik's Selectra 3D catheter and Solia S lead system for left bundle branch area pacing (LBBAP).
  • The approval was based on the BIO-CONDUCT trial, which demonstrated a 95.7% implant success rate and a low 1.7% lead-related complication rate.
  • The Solia S lead offers advantages over previous LBBAP leads, including continuous pacing off the stylet during implantation, according to Larry Chinitz, MD.

ICMR Partners to Initiate First-in-Human Trials for Four Novel Molecules

  • The Indian Council of Medical Research (ICMR) has entered into agreements to begin first-in-human clinical trials for four new drug molecules targeting various diseases.
  • These trials mark a significant step in indigenous pharmaceutical research and development, potentially offering new treatment options.
  • The partnerships aim to accelerate the clinical development process, bringing innovative therapies to patients in need more efficiently.
  • The molecules target conditions with unmet medical needs, reflecting ICMR's commitment to addressing critical healthcare challenges.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial

  • Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo.
  • The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation.
  • Boehringer Ingelheim plans to submit a new drug application to the FDA and other health authorities for nerandomilast as a treatment for idiopathic pulmonary fibrosis (IPF).
  • Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, has received Breakthrough Therapy Designation from the FDA for IPF and is being investigated in two Phase III trials.

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

NCT05321069CompletedPhase 3
Boehringer Ingelheim
Posted 10/6/2022

A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)

NCT05321082CompletedPhase 3
Boehringer Ingelheim
Posted 11/16/2022

InspireMD Submits CGuard Carotid Stent for FDA Approval

  • InspireMD has submitted a premarket approval (PMA) application to the FDA for its CGuard Prime carotid stent system, designed for treating carotid artery stenosis.
  • The PMA application is based on positive one-year data from the C-GUARDIANS pivotal clinical trial, which involved 316 patients across 24 sites in the U.S. and Europe.
  • C-GUARDIANS demonstrated a primary endpoint major adverse event rate of 1.95% at 12 months, the lowest reported for any carotid stent pivotal trial.
  • The CGuard EPS system, designed to prevent stroke, previously received CE mark and utilizes MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes.

Apple Watch Receives FDA Clearance for Sleep Apnea Detection Feature

  • Apple's new sleep apnea detection feature has received FDA clearance, positioning the Apple Watch as a more accessible alternative to traditional sleep apnea tests.
  • The feature, utilizing a new metric called "breathing disturbances," will be available on Apple Watch Series 9, Series 10, and Ultra 2.
  • The Apple Watch uses its accelerometer to monitor wrist movements during sleep, identifying disruptions in normal breathing patterns indicative of sleep apnea.
  • Users can track their breathing disturbance data in the Health app and share comprehensive reports with healthcare providers for further evaluation.

Liraglutide Shows Promise in Pediatric Obesity, While Oncology Trials Face Setbacks

  • Novo Nordisk's liraglutide demonstrated a significant reduction in BMI in a Phase III trial involving children aged 6-11, showing potential for pediatric obesity treatment.
  • Vaxcyte's VAX-31 pneumonia vaccine showed positive Phase I/II topline data, increasing its Phase Transition Success Rate (PTSR) in streptococcal pneumonia.
  • Pfizer terminated a Phase I trial of maplirpacept, leading to a decrease in its PTSR for peripheral T cell lymphoma and B cell Hodgkin lymphoma.
  • Les Laboratoires Servier's oncology drug trial was terminated due to business reasons, impacting the PTSR of S-64315 and S-65487 in multiple myeloma and leukemia.

A Clinical Trial to Learn About the Study Medicine Called Maplirpacept (PF-07901801), Alone and When Used in Combination With Other Medicines to Treat Participants With Advanced Hematological Malignancies, Including Lymphoma, Leukemia and Multiple Myeloma

NCT03530683Active, Not RecruitingPhase 1
Pfizer
Posted 6/7/2018

Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults

NCT06151288Active, Not RecruitingPhase 1
Vaxcyte, Inc.
Posted 11/8/2023

Study of Subretinally Injected ATSN-101 Administered in Patients With Leber Congenital Amaurosis Caused by Biallelic Mutations in GUCY2D

NCT03920007Active, Not RecruitingPhase 1
Atsena Therapeutics Inc.
Posted 9/12/2019

SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

NCT04775082Active, Not RecruitingPhase 3
Novo Nordisk A/S
Posted 3/4/2021

VOB560-MIK665 Combination First in Human Trial in Patients With Hematological Malignancies (Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Acute Myeloid Leukemia, or Relapsed/Refractory Multiple Myeloma)

NCT04702425TerminatedPhase 1
Novartis Pharmaceuticals
Posted 6/23/2021

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