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Clinical Trial News

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.

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

NCT06151288CompletedPhase 1
Vaxcyte, Inc.
Posted 11/8/2023

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

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

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

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

Apple Watch Receives FDA Clearance for Sleep Apnea Detection

  • The Apple Watch has secured FDA clearance for its new sleep apnea detection feature, marking a significant advancement in consumer health technology.
  • The feature utilizes the watch's sensors to monitor sleep patterns and identify potential indicators of sleep apnea, a widespread sleep disorder.
  • This clearance enables Apple to market the Apple Watch as a tool for preliminary sleep apnea screening, potentially reaching a broad user base.
  • The FDA's decision underscores the increasing role of wearable devices in proactive health monitoring and early disease detection.

FDA Lifts Clinical Hold on Zentalis' Azenosertib Trials, Boosting Cancer Research

• The FDA has lifted the partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing for the resumption of patient enrollment in ongoing trials. • The decision follows a comprehensive safety assessment review by the FDA, reinforcing confidence in azenosertib's therapeutic potential, especially for gynecologic malignancies. • Azenosertib, an orally bioavailable WEE1 inhibitor, is being evaluated as both a monotherapy and in combination to treat ovarian cancer and other tumor types. • Zentalis plans to present monotherapy data on azenosertib later in 2024, providing updates on clinical development timelines and data presentation.

A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma

NCT05765812RecruitingPhase 1
Debiopharm International SA
Posted 5/15/2023

A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT05128825RecruitingPhase 2
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Posted 2/17/2022

A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

NCT04814108RecruitingPhase 2
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Posted 7/28/2021

A Study of ZN-c3 in Participants With Solid Tumors

NCT04158336RecruitingPhase 1
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Posted 11/1/2019

A Study of ZN-c3 in Patients With Ovarian Cancer

NCT04516447RecruitingPhase 1
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Posted 10/26/2020

FDA Approves Subcutaneous Ocrevus Zunovo for Multiple Sclerosis

  • The FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) as a twice-yearly, 10-minute subcutaneous injection for both relapsing and primary-progressive multiple sclerosis.
  • Approval was based on the Phase III OCARINA II trial, which demonstrated equivalent drug levels, comparable safety, and high patient satisfaction compared to intravenous Ocrevus.
  • Ocrevus Zunovo offers an alternative administration method, providing greater flexibility for healthcare providers and patients based on individual treatment needs.
  • The OCARINA II trial showed Ocrevus Zunovo effectively suppressed relapse activity and MRI lesions by 97% over 48 weeks, consistent with the IV formulation.

Boehringer Ingelheim Seeks Approval for Nerandomilast After Positive Phase III IPF Trial

• Boehringer Ingelheim is seeking regulatory approval for nerandomilast after its Phase III FIBRONEER-IPF trial met the primary endpoint of improving forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF). • The FIBRONEER-IPF trial, involving 1,177 patients, demonstrated that nerandomilast significantly improved lung function compared to placebo over 52 weeks; full data will be presented in H1 2025. • Nerandomilast, a preferential phosphodiesterase 4B (PDE4B) inhibitor, received breakthrough therapy designation from the FDA in 2022 and is also being investigated for progressive fibrosing interstitial lung diseases. • With limited FDA-approved treatments for IPF, nerandomilast represents a potential new option, as the trial is the first successful late-stage IPF trial in a decade.

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

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