Actuate Therapeutics Inc. (ACTU), a clinical-stage biopharmaceutical company, announced the publication of new positive data from the Phase 2 clinical trial for Elraglusib in combination with Gemcitabine-nab-Paclitaxel (GnP) in treating metastatic pancreatic cancers in the Nature Medicine journal.
The company's lead investigational drug, Elraglusib (9-ING-41), is a glycogen synthase kinase-3 beta (GSK-3ß) inhibitor developed to treat pancreatic cancers, including pancreatic ductal adenocarcinoma (PDAC).
The Phase 2 trial is a global, randomised, open-label study evaluating Elraglusib in combination with GnP compared with GnP alone.
Conducted with 286 patients across 60 sites, efficacy analyses focused on 155 patients treated with once-weekly Elraglusib plus GnP and 78 patients receiving GnP alone.
The new data indicated an increase in median overall survival (OS) of 10.1 months with combination therapy, compared with 7.2 months with GnP alone.
Additionally, the combination therapy reduced death rate by 38%, one-year survival rates were at 44.1% for those on Elraglusib/GnP, compared with 22.3% in patients treated with GnP alone.
Safety was generally manageable with the Elraglusib/GnP combination, with the most common Grade 3 or higher adverse events including neutropenia, anaemia, and fatigue.
Also, the 19-month survival rate was above 20% in the Elraglusib/GnP arm compared to 4% in the control arm.
"These Phase 2 results continue to reinforce Elraglusib's potential as a combination-ready, first-line therapy with the ability to enhance the activity of standard of care chemotherapeutic backbones," said Daniel Schmitt, Chief Executive Officer of Actuate.
ACTU closed Tuesday at $2.08, up 14.27%. In the overnight market, shares are trading at $2.14, up 2.88%.
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