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Clinical Trial News

NeuroSense Therapeutics Presents PrimeC Data at ALS/MND Symposium

  • NeuroSense Therapeutics will present Phase 2b PARADIGM trial results of PrimeC, a potential ALS treatment, at the International Symposium on ALS/MND.
  • Prof. Merit Cudkowicz will present the latest clinical outcomes from the PARADIGM trial, offering insights into PrimeC's potential to improve patient outcomes.
  • Dr. Cristian Lunetta will share an in-depth biomarker analysis from the PARADIGM trial, providing critical insights into PrimeC's mechanism of action.
  • The NeuroSense management team will attend, highlighting the company's commitment to advancing ALS research and neurodegenerative disease therapies.

A Phase IIb, Multi-Center, Multinational, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

NCT05357950Active, Not RecruitingPhase 2
NeuroSense Therapeutics Ltd.
Posted 5/31/2022

FDA Accepts sNDA for Darolutamide Plus ADT in Metastatic Hormone-Sensitive Prostate Cancer

• The FDA has accepted a supplemental new drug application (sNDA) for darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) for metastatic hormone-sensitive prostate cancer (mHSPC). • The sNDA is supported by data from the pivotal Phase 3 ARANOTE trial, which demonstrated a significant extension in radiological progression-free survival (rPFS) compared to placebo plus ADT. • Darolutamide plus ADT showed a 46% reduction in the risk of radiological progression or death (HR, 0.54; 95% CI, 0.41-0.71; P < .0001) at 24 months. • Bayer is seeking approval for this indication in the EU, potentially expanding the treatment options for patients with mHSPC.

Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

NCT04736199Active, Not RecruitingPhase 3
Bayer
Posted 2/23/2021

FDA Approves Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer

• The FDA has granted accelerated approval to Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC). • Approval was based on a 52% objective response rate and a median duration of response of 14.9 months in the HERIZON-BTC-01 clinical trial. • Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC, offering a new chemotherapy-free treatment option. • A confirmatory Phase 3 trial is ongoing to further evaluate zanidatamab in combination with standard-of-care therapy for first-line treatment of HER2-positive BTC.

EmStop Completes CAPTURE-1 Trial for Integrated Embolic Protection During TAVR

  • EmStop, Inc. has concluded its CAPTURE-1 early feasibility trial, evaluating the safety and performance of its embolic protection system during TAVR procedures.
  • The trial involved 15 subjects undergoing TAVR with the EmStop system, designed to capture and remove thrombus, potentially reducing the risk of stroke.
  • Results are being prepared for regulatory submission, with plans for future data publication and additional clinical trials to further assess the technology.
  • The EmStop system offers complete cerebral protection without disrupting procedural efficiency or requiring additional vascular access, according to investigators.

Controlled Arterial Protection to Ultimately Remove Embolic Material

NCT06103591CompletedNot Applicable
EmStop Inc
Posted 12/27/2023

Phase 3 Trial of Solengepras for Parkinson's Disease Begins Dosing

• Cerevance's solengepras, an oral GPR6 inhibitor, has entered a Phase 3 clinical trial (ARISE) as an add-on therapy for Parkinson's disease. • The ARISE trial (NCT06553027) will evaluate solengepras' efficacy in reducing off-time in Parkinson's patients already treated with levodopa. • Solengepras aims to improve motor control and reduce dyskinesia by modulating brain circuits without directly relying on dopamine pathways. • Topline data from the ARISE trial is expected in the first half of 2026, with a focus on changes in daily off-time after 12 weeks of treatment.

Early Parkinson's Disease Monotherapy With CVN424

NCT06006247CompletedPhase 2
Cerevance Beta, Inc.
Posted 9/11/2023

To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications

NCT06553027RecruitingPhase 3
Cerevance
Posted 9/20/2024

Study of CVN424 in Parkinson's Disease Patients With Motor Fluctuations

NCT04191577CompletedPhase 2
Cerevance Beta, Inc.
Posted 12/2/2019

Neuralink Expands Human Trials to Canada Following Health Canada Approval

  • Neuralink has received approval from Health Canada to begin human trials of its brain-computer interface (BCI) implant, marking its first clinical trials outside the U.S.
  • The trials, named CAN-PRIME study, will evaluate the safety of Neuralink's implant and surgical robot, as well as the initial functionality of the BCI for enabling individuals with quadriplegia to control external devices with their thoughts.
  • Neuralink is actively recruiting participants in Canada who have limited or no use of their hands due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS).
  • The Toronto Western Hospital will serve as the exclusive surgical site for the Canadian trials, building on Neuralink's experience from initial human implants in the U.S.

New Amsterdam's Obicetrapib-Ezetimibe Combo Shows Promise in Phase III Trial for Cardiovascular Disease

  • New Amsterdam's Phase III TANDEM trial met its co-primary endpoints, demonstrating a significant reduction in LDL-C levels in patients with HeFH or ASCVD.
  • The obicetrapib-ezetimibe fixed-dose combination achieved a 48.6% reduction in LDL-C compared to monotherapy after 84 days.
  • The combination treatment was well-tolerated, with a safety profile comparable to placebo, supporting regulatory filings.
  • These results, combined with previous trial successes, suggest obicetrapib's potential as a once-daily treatment for lowering LDL-C and improving cardiovascular outcomes.

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT06005597CompletedPhase 3
NewAmsterdam Pharma
Posted 3/1/2024

VistaGen's Anxiety Drug Trials Maintain Stifel's Optimism

  • VistaGen Therapeutics is progressing with Phase 3 clinical trials for fasedienol, a drug candidate for Social Anxiety Disorder (SAD).
  • Stifel reiterated a Buy rating on VistaGen's stock, citing the potential success of the PAL-3 and PAL-4 trials.
  • VistaGen is also advancing itruvone into Phase 2b trials and preparing for a U.S. IND submission for PH80 for menopausal hot flashes.
  • The company's shares are trading near cash value, presenting a favorable risk/reward balance according to Stifel.

FDA Approves Kedrion's Bolognana Facility for RYPLAZIM Production, Expanding Access to PLGD-1 Treatment

  • The FDA has approved Kedrion Biopharma's Bolognana facility for producing RYPLAZIM, the first and only treatment for plasminogen deficiency type 1 (PLGD-1).
  • This approval significantly expands RYPLAZIM's production capacity, ensuring more patients globally can access this crucial therapy for the rare disease.
  • RYPLAZIM addresses the root cause of PLGD-1, offering patients the potential for a near-normal life by targeting fibrin-rich lesions.
  • The expanded production aims to meet the growing demand for RYPLAZIM, providing confidence to diagnosed patients that they will receive needed treatment.

FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer

  • The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for adults with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC).
  • Ziihera is the first dual HER2-targeted bispecific antibody approved for this patient population in the United States, offering a chemotherapy-free treatment option.
  • The approval was based on a 52% objective response rate and a median duration of response of 14.9 months in the phase 2b HERIZON-BTC-01 clinical trial.
  • A confirmatory phase 3 trial, HERIZON-BTC-302, is ongoing to verify the clinical benefit of Ziihera, which carries a Boxed Warning for embryo-fetal toxicity.

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