Clinical Trial News
QuantHealth Secures $17M Series A Funding to Advance AI-Powered Clinical Trial Simulations
- QuantHealth has raised $17M in Series A funding, including a strategic investment from Accenture Ventures, to accelerate the development of AI-powered clinical trial simulations.
- The company's AI platform, trained on 350 million patient records and biomedical knowledge graphs, achieves 86% accuracy in predicting trial outcomes using binary endpoint metrics.
- The technology aims to transform pharmaceutical R&D by reducing the $1 billion+ cost of drug development through optimized trial design and improved success prediction.
GSK Acquires Aiolos Bio for $1.4B, Expanding Asthma Treatment Portfolio with Novel TSLP Inhibitor
- GSK has announced a $1.4 billion acquisition of Aiolos Bio, including a $1 billion upfront payment, to secure AIO-001, a promising long-acting anti-TSLP antibody for severe asthma treatment.
- AIO-001 demonstrates potential advantages with twice-yearly dosing compared to current monthly treatments, and could benefit patients with both high and low T2 inflammation types of severe asthma.
- The acquisition strengthens GSK's respiratory medicine portfolio and follows their recent $2 billion Bellus Health purchase, showing strategic pipeline expansion ahead of key patent expirations.
Mobile Application Reduces Opioid Misuse After Cesarean Section
A study evaluates the effectiveness of the Continuing Precision Medicine (CPM) mobile application in reducing opioid misuse among women post-cesarean section, showing significant reductions in misuse and suggesting more appropriate prescription sizes.
FDA Accepts NDA for SH-105, a Ready-to-Dilute Formulation for Breast and Ovarian Cancer
- The FDA has accepted a New Drug Application (NDA) for SH-105, a ready-to-dilute formulation of a treatment for breast and ovarian adenocarcinoma.
- SH-105 offers clinicians and patients an easier-to-administer injectable product with unique characteristics, potentially facilitating rapid adoption upon approval.
- The original agent, improved by SH-105, was approved in the 1950s; this new formulation simplifies the drug reconstitution process, enhancing efficiency and safety.
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2024, for SH-105.
Real-World Study Highlights Adverse Events Associated with Lenvatinib Use
A comprehensive real-world drug safety surveillance study on lenvatinib has identified significant adverse events (AEs) linked to its use, including immune-mediated hepatitis, portal vein thrombosis, and adrenal insufficiency. The study, analyzing data from 2015 to 2023, found that most AEs occurred within the first month of treatment, with a median onset time of 41 days. Specific targets of lenvatinib, such as FGFR4, PDGFRA, and KIT, were potentially linked to conditions like cholecystitis, cholangitis, and hepatic encephalopathy.
GLP-1 Receptor Agonists Show Promise for Weight Loss in Overweight and Obese Individuals Without Diabetes
A comprehensive study evaluating the benefit-harm balance of GLP-1 receptor agonists (RAs) for weight loss in individuals with overweight and obesity but without diabetes has found that these drugs can offer significant weight loss benefits, especially when aiming for a 10% reduction in body weight. However, the net benefit is highly dependent on individual treatment goals and tolerance for potential harms.
Doxycycline Post-Exposure Prophylaxis Shows Promise in Reducing STIs Among MSM
Recent studies highlight the effectiveness of Doxycycline Post-Exposure Prophylaxis (doxy-PEP) in reducing Chlamydia trachomatis and Treponema pallidum infections among men who have sex with men (MSM), though questions remain about its efficacy against Neisseria gonorrhoeae and among cisgender women.
Disitamab Vedotin Shows Promising Results in Advanced Urothelial Carcinoma Treatment at 2024 ESMO Congress
At the 2024 ESMO Congress, Disitamab Vedotin, combined with a PD-1 inhibitor, demonstrated significant efficacy and manageable safety profiles as a first-line treatment for advanced urothelial carcinoma, with a median overall survival of 33.1 months, surpassing traditional chemotherapy outcomes.
Alnylam's AMVUTTRA Shows Significant Cardiac Benefits in ATTR Amyloidosis Patients at ACC.25
- New data from the HELIOS-B Phase 3 trial demonstrates vutrisiran improves cardiac function and maintains quality of life in patients with ATTR amyloidosis with cardiomyopathy.
- Patients treated with vutrisiran showed improvements in diastolic function and reduced decline in ventricular systolic function compared to placebo, with greatest benefits observed in early-stage disease.
- The findings build upon recent FDA approval of AMVUTTRA as the first RNAi therapeutic for ATTR-CM to reduce cardiovascular mortality, hospitalizations, and urgent heart failure visits.
Genascence Advances First Gene Therapy for Knee Osteoarthritis in Phase 1B DONATELLO Trial
- Genascence has initiated the Phase 1B DONATELLO trial evaluating GNSC-001, a novel gene therapy designed to block IL-1 signaling in knee osteoarthritis patients, with enrollment ongoing at 10 U.S. clinical sites.
- GNSC-001 uses an AAV vector to deliver an optimized IL-1Ra protein, potentially providing long-lasting suppression of inflammation and cartilage destruction with a single intra-articular injection.
- Previous Phase 1 data showed GNSC-001 was well-tolerated with sustained IL-1Ra expression for 12 months, with the company expecting to complete current trial enrollment by Q1 2024 and release topline data by Q4 2024.
Highlighted Clinical Trials:
Genascence Corporation
Posted 6/12/2023
Mayo Clinic
Posted 6/5/2019