Core Insights - Actuate Therapeutics announced that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met primary endpoints and achieved statistical significance in the ongoing Phase 2 trial for metastatic pancreatic ductal adenocarcinoma (mPDAC) [1][7] - The topline results indicate a substantial improvement in median overall survival compared to previous data, with details to be presented at the ASCO Annual Meeting on May 31, 2025 [2][7] Company Overview - Actuate Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for high-impact, difficult-to-treat cancers, specifically targeting GSK-3β to inhibit tumor growth [1][8] - The lead investigational drug, elraglusib, aims to enhance chemotherapy activity and activate anti-tumor immunity through various mechanisms [6][8] Clinical Trial Details - The Actuate-1801 Part 3B study is a randomized, controlled Phase 2 trial involving 286 mPDAC patients, comparing elraglusib with GnP versus GnP alone [5] - The primary endpoint of the study is median overall survival, with secondary endpoints including disease control rate (DCR), overall response rate (ORR), progression-free survival (PFS), and adverse events (AE) [5] Presentation Information - The topline data will be presented in an oral session at the ASCO Annual Meeting, with the abstract titled "Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone" [4][7]
Actuate Therapeutics Announces Statistically Significant Topline Results from Global Phase 2 Trial of Elraglusib in First-Line Treatment of Metastatic Pancreatic Cancer