Clinical Trial News
Know Labs Presents Promising Clinical Data on Non-Invasive Glucose Monitoring Technology
- Know Labs presented clinical study results at the AACE Annual Meeting, demonstrating the accuracy of its non-invasive glucose monitoring sensor.
- The study involved individuals with diabetes and used venous blood as a reference, employing a machine learning model for data analysis.
- Know Labs plans to conduct large-scale clinical trials with its KnowU™ wearable CGM to assess performance in real-world conditions and extreme glycemic ranges.
- The company is advancing towards FDA clearance, with the goal of providing accessible and affordable real-time blood glucose information.
Acelyrin Provides Update on Clinical Programs and Business Strategy
- Acelyrin completed enrollment in the Phase 3 trial of izokibep for hidradenitis suppurativa, with top-line data expected in the third quarter of 2024.
- Positive proof-of-concept data were reported for lonigutamab in thyroid eye disease, with a Phase 2b/3 trial planned for initiation in the second half of 2024.
- The company anticipates completing enrollment in the Phase 2b/3 trial of izokibep for uveitis this month, with top-line data expected by year-end 2024.
- Acelyrin reported a cash position of $678.5 million as of March 31, 2024, expected to fund operations into 2026, while also considering options to extend its cash runway.
R3 Vascular Secures $87 Million in Series B Financing and Appoints New CEO
R3 Vascular Inc., a medical device company focused on developing bioresorbable scaffolds for peripheral arterial disease (PAD), has announced the completion of an $87 million Series B financing round. The funding, led by Deerfield Management, will support the ELITE FDA IDE pivotal trial of its MAGNITUDE® bioresorbable scaffold for below-the-knee PAD, alongside R&D, regulatory submissions, and manufacturing scale-up. Christopher M. Owens has been appointed as the new President and CEO, bringing over three decades of medical device industry experience to the role.
Siren Biotechnology Partners with Catalent to Advance AAV Immuno-Gene Therapies for Cancer
• Siren Biotechnology and Catalent have formed a strategic partnership to develop and manufacture AAV vector-based immuno-gene therapies for cancer treatment, with Catalent providing cGMP manufacturing for clinical trials.
• The collaboration leverages Catalent's unique position as the only U.S. CDMO with FDA approval for AAV-based gene therapies, supporting Siren's goal of rapidly advancing its therapeutic programs to the clinic.
• This partnership aims to pioneer new pathways for developing cancer treatments that combine AAV gene therapy and cytokine immunotherapy into a single modality designed to destroy tumor cells and elicit anti-tumor immunity.
CEL-SCI Receives FDA Approval for Confirmatory Study of Multikine in Head and Neck Cancer Treatment
CEL-SCI Corporation has received FDA approval to proceed with a confirmatory study of its cancer immunotherapy, Multikine, for newly diagnosed advanced primary head and neck cancer patients. The study, based on strong safety and efficacy data from a completed Phase 3 study, aims to confirm the survival benefits observed in the target patient population.
Tivic Health's Non-Invasive Vagus Nerve Stimulation Shows Promising Results in Clinical Trial
- Tivic Health's pilot study demonstrated significant physiological responses to their non-invasive cervical vagus nerve stimulation (ncVNS) technology, including a 97% increase in heart rate variability, a key indicator of vagus nerve activity.
- The 20-person clinical trial, conducted with the Feinstein Institutes for Medical Research, showed measurable effects on brain activity with a 24% increase in frontal theta power and 66% reduction in frontal gamma power, consistent with reduced anxiety.
- Researchers believe the technology may have clinical applications for conditions including epilepsy, post-traumatic stress disorder, and ischemic stroke, potentially offering non-surgical alternatives in the growing $8.3B neurostimulation market.
Teva and Medincell Announce Positive Phase 3 Efficacy Results for TEV-749 in Schizophrenia Treatment
Teva Pharmaceuticals and Medincell have reported positive Phase 3 efficacy results for TEV-749, a once-monthly subcutaneous long-acting injectable of olanzapine, showing significant improvements in schizophrenia symptoms without the risk of post-injection delirium/sedation syndrome (PDSS).
Apple Watch's AFib History Feature Gains FDA Qualification for Clinical Trials
- The Apple Watch's Atrial Fibrillation (AFib) History feature is the first digital tool qualified under the FDA's Medical Device Development Tools (MDDT) program.
- This qualification allows the Apple Watch to be used as a secondary endpoint in clinical trials, specifically for cardiac ablation devices.
- The AFib History feature provides a non-invasive method to estimate AFib burden, measuring the amount of time spent in atrial fibrillation.
- The FDA's decision validates the Apple Watch as a reliable tool for monitoring arrhythmia and assessing the effectiveness of cardiac treatments.
Arcturus Therapeutics Announces Positive Clinical Updates and Financial Results for Q1 2024
- Arcturus Therapeutics is on track to deliver initial 4 million doses of Kostaive® in Q3, with European approval decision expected in the same quarter.
- Phase 1b interim data for ARCT-032 (LUNAR-CF) and Phase 2 data for ARCT-810 (LUNAR-OTC) are scheduled for release on July 1st, providing updates on mRNA therapeutic programs.
- Arcturus' bivalent COVID-19 vaccine candidate, ARCT-2301, met its primary endpoint in a Phase 3 clinical study in Japan, demonstrating non-inferiority.
- The company's cash runway extends to the first quarter of fiscal year 2027, supported by strategic alliances and collaborations, including ongoing development with CSL.
FDA Approves Sunlenca (Lenacapavir), a First-in-Class HIV-1 Capsid Inhibitor
- The FDA has approved Sunlenca (lenacapavir) as the first capsid inhibitor for heavily treatment-experienced adults with multi-drug resistant HIV-1 infection.
- Sunlenca, administered twice-yearly, offers a novel mechanism of action by blocking the HIV-1 virus's protein shell, addressing a critical unmet need.
- Clinical trial data from the CAPELLA trial demonstrated that 83% of participants achieved undetectable viral load at Week 52 with lenacapavir plus an optimized background regimen.
- The approval marks a significant advancement, potentially improving outcomes for patients with limited treatment options and complex resistance profiles.