Clinical Trial News

Valneva SE submitted label extension applications to EMA and Health Canada for its chikungunya vaccine, IXCHIQ, to expand use to adolescents aged 12-17 in Europe and Canada. The company plans to submit data to the FDA this year for potential U.S. label extensions. IXCHIQ is currently approved for individuals 18 and older in the U.S., Europe, and Canada, with first sales anticipated in Q4 2024. Valneva expects marketing authorization in Brazil in H2 2024 and expanded partnership with CEPI for broader vaccine access in LMICs, supported by up to $41.3 million in additional funding.

A 3-week hypofractionated RT course showed noninferiority to 5-week normofractionated RT in reducing lymphedema risk in early-stage breast cancer, with similar survival outcomes and no increased toxicity, according to the HypoG-01 trial. The study concludes that 3-week nodal RT should be the standard for breast cancer treatment.

Autobahn Therapeutics initiated AMPLIFY Phase II trial assessing ABX-002 as adjunctive treatment for MDD in adults. The placebo-controlled, double-blind study involves 230 participants and evaluates tolerability, safety, efficacy, and pharmacodynamic effects alongside existing SSRI or SNRI treatments. Primary success measure is HAMD-17 change after six weeks. Secondary endpoints include HAMD-29 and Montgomery–Åsberg Depression Rating Scale. Topline data expected in H2 next year, with another Phase II trial for bipolar disorder depression planned by year-end.

Eli Lilly's Q2 revenue surged 36% due to new product launches, but faces supply constraints and a 31% decline in Trulicity revenue. The company's financial health is strong with a 90% increase in operating income, but R&D expenses rose 15%. Eli Lilly's innovative pipeline and strategic acquisitions offer growth opportunities, despite high P/E ratio of 111.1x.

The NIAGARA trial showed durvalumab with neoadjuvant chemotherapy improved event-free and overall survival in muscle-invasive bladder cancer patients, presented at ESMO 2024 and published in NEJM.

Hyundai Bioscience collaborates with UCSD to trial Xafty, a niclosamide-based antiviral, for treating Long-COVID, aiming to address complex symptoms through multiple mechanisms.

80% of advanced-phase CML or Philadelphia chromosome-positive AML patients achieved bone marrow remission with decitabine, venetoclax, and ponatinib combination therapy, according to a Phase II trial published in The Lancet Haematology.

177Lu-PSMA-617 plus docetaxel improved outcomes in metastatic hormone-sensitive prostate cancer (mHSPC) without increased toxicity compared to docetaxel alone, according to the phase 2 UpFrontPSMA study. The addition of lutetium-PSMA to docetaxel significantly improved undetectable PSA levels at 48 weeks and multiple secondary endpoints with no increase in overall toxicity.

Oregon State University researchers, with a $1.2 million NIH grant, aim to develop an AI-powered device using saliva for personalized epilepsy treatment, optimizing anti-seizure drug dosing.

FDA approves pembrolizumab (Keytruda) plus pemetrexed and platinum-based chemotherapy as first-line therapy for unresectable advanced or metastatic malignant pleural mesothelioma (MPM). The approval is based on KEYNOTE-483 trial data showing improved median overall survival (OS) and progression-free survival (PFS) with the combination therapy compared to chemotherapy alone. The recommended dose is 200 mg every 3 weeks or 400 mg every 6 weeks for up to 2 years.