Clinical Trial News

The FDA has approved SELARSDI (ustekinumab-aekn), a biosimilar developed by Alvotech and commercialized by Teva, for treating moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged 6 and older.

Rilzabrutinib's LUNA 3 phase 3 study met its primary endpoint, showing significant durable platelet response in ITP patients. Regulatory submissions in the US and EU are expected by year-end. Rilzabrutinib, part of Sanofi's immunology pipeline, is also being studied for other immune-mediated diseases.

Abeona Therapeutics receives a Complete Response Letter from the FDA for its Biologics License Application for prademagene zamikeracel (pz-cel) due to unresolved Chemistry Manufacturing and Controls (CMC) requirements, with no deficiencies identified in clinical efficacy or safety data. The company plans to resubmit the BLA in the third quarter of 2024.

Metformin, a diabetes drug, may slow aging and prevent age-related diseases. The TAME Trial aims to test its effects on healthy older adults. Despite promising observational evidence, funding challenges hinder the study. Metformin's potential benefits include reduced cancer risk, improved cardiovascular outcomes, and cognitive decline prevention, but its efficacy in healthy individuals remains unproven.

FDA approved ciltacabtagene autoleucel (cilta-cel) for relapsed/refractory multiple myeloma, showing a 59% risk reduction in disease progression or death vs standard care in the CARTITUDE-4 trial. Despite early OS concerns, cilta-cel's benefits outweigh risks, offering a treatment-free period post-administration. Accessibility and logistics remain challenges.

Arbor Biotechnologies™ received FDA clearance for ABO-101's IND application, targeting PH1 with a CRISPR-based therapy. The redePHine study will evaluate ABO-101's safety and efficacy in PH1 patients. ABO-101 aims to reduce oxalate levels by editing the HAO1 gene, offering a potential first-in-class treatment for PH1.

Nexcella, an Immix Biopharma subsidiary, is on track to dose relapsed/refractory AL Amyloidosis patients with CAR-T NXC-201 in mid-2024 at U.S. sites, including New York City. The NEXICART-2 trial aims to enroll 40 patients over 18 months, focusing on safety and efficacy. NXC-201 has FDA and EMA Orphan Drug Designation.

Psyence Biomedical Ltd announced its Phase IIb clinical trial for nature-derived psilocybin treatment in patients with Adjustment Disorder post-advanced cancer diagnosis, listed on ANZCTR. The trial, involving 84 patients, tests three psilocybin doses with psychotherapy, aiming for primary endpoint results by 2025.

Diamyd Medical's DIAGNODE-B trial, published in the International Journal of Molecular Sciences, shows redosing Diamyd® (GAD-Alum) with vitamin D in Type 1 Diabetes patients is safe and may preserve beta-cell function, improving glycemic control and reducing insulin needs. The trial involved six participants with specific genetic traits, showing stable insulin production and immune modulation over 12 months.

Xeltis announces aXess trial results at the 46th Annual Charing Cross Symposium, showcasing a restorative conduit for hemodialysis vascular access. aXess creates long-term living vessels, improving patient experience by reducing reinterventions and infections. Presentations by Dr. Shahverdyan and Prof Dr. Moll highlight advancements and infection control in vascular conduits.