clinical trials

Genentech announced topline results from the Phase IIb ALIENTO and Phase III ARNASA trials evaluating astegolimab for COPD. ALIENTO met its primary endpoint, demonstrating a statistically significant reduction in the annualized exacerbation rate (AER) at 52 weeks. However, ARNASA did not meet its primary endpoint, despite a numerical reduction in AER. Astegolimab’s safety profile remained consistent with prior data. Genentech will discuss the data with regulatory authorities and present it at a future medical meeting. The trials included diverse COPD patients.

Lilly announced positive Phase 3 trial results for once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. The QWINT-1, QWINT-3, and QWINT-4 trials demonstrated non-inferior A1C reduction compared to daily basal insulin. The company plans to submit efsitora for regulatory review by the end of the year.

Lipella Pharmaceuticals Inc. is delisted from the Nasdaq Capital Market due to rule violations regarding private placement transactions. The delisting, involving the issuance of convertible preferred stock and warrants, led to the suspension of trading. While disappointed, the company is exploring alternative markets, remains focused on its clinical development plans for LP-10 and LP-310, and is pressing forward with its mission to address unmet medical needs.

TCTM Kids IT Education Inc. (VSA) announced a non-binding LOI to acquire HopeAI, a leader in AI solutions for clinical development. This move aims to expand VSA’s presence in the AI-driven biopharmaceutical sector. HopeAI’s platforms offer solutions to reduce clinical trial timelines and improve efficiency. The acquisition is subject to customary closing conditions and will allow VSA to leverage HopeAI’s technology to advance drug development.

The TROPION-Lung02 and TROPION-Lung04 trials support DATROWAY (datopotamab deruxtecan) combined with immunotherapy as a first-line treatment for advanced NSCLC. TROPION-Lung02 showed a 54.8% objective response rate with DATROWAY and pembrolizumab. Exploratory analyses show promising biomarker associations and the TROPION-Lung04 study found a 57.5% objective response rate when using DATROWAY with rilvegostomig. NeoCOAST-2 data also revealed positive results in the neoadjuvant setting.