Actuate Completes Enrollment for Phase 2 Trial of Elraglusib with FOLFIRINOX and Losartan in Untreated Metastatic Pancreatic Cancer

Actuate Therapeutics, Inc., a biopharmaceutical company known for its focus on developing cancer therapies, recently concluded patient enrollment for a Phase 2 clinical trial. This trial examines the effectiveness of combining FOLFIRINOX with the investigational drug elraglusib (9-ING-41) and losartan for patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). The study is conducted under the guidance of Dr. Colin Weekes at Massachusetts General Hospital, with additional support from the Lustgarten Foundation and multiple research sites, including the University of Colorado and the University of Washington’s Fred Hutchinson Cancer Center.

The trial aims to evaluate the safety, tolerability, and progression-free survival of this drug combination. With 56 treatment-naïve mPDAC patients enrolled, the study is a significant step in exploring new treatment avenues for this challenging form of cancer. Actuate's President and CEO, Daniel Schmitt, emphasized the importance of reaching this enrollment milestone, noting the promising initial data presented at a conference in September 2024. This data suggested enhanced clinical activity when elraglusib is combined with FOLFIRINOX and losartan, indicating potential advancements in treating mPDAC.

Dr. Colin Weekes, the principal investigator, expressed optimism about the trial's potential to improve treatment options for metastatic pancreatic cancer. The team looks forward to the trial's final results in 2026, which they hope will provide deeper insights into more effective therapies for patients.

Elraglusib, Actuate's leading investigational drug, is designed to inhibit glycogen synthase kinase-3 beta (GSK-3β), a target known to play a role in tumor growth and resistance to standard cancer treatments. By blocking this pathway, elraglusib may enhance anti-tumor immunity and regulate immune checkpoints, offering a novel approach to cancer therapy.

Furthermore, interim data from another Phase 2 trial involving elraglusib with gemcitabine/nab-paclitaxel for first-line treatment of mPDAC showed statistically significant improvements in survival rates. This finding highlights the potential of elraglusib in combination with various chemotherapy regimens, underscoring Actuate's commitment to exploring multiple therapeutic strategies for challenging cancers like pancreatic cancer.

Massachusetts General Hospital, the primary site for the trial, is renowned for its extensive research infrastructure and deep commitment to advancing medical knowledge. Founded in 1811, it serves as a primary teaching hospital for Harvard Medical School and is a key member of the Mass General Brigham healthcare system. The hospital's research institute is among the largest in the U.S., emphasizing its pivotal role in medical innovation.

Overall, the completion of patient enrollment in this trial marks a significant advancement in the ongoing quest to tackle metastatic pancreatic cancer. As researchers and clinicians await the trial's final results, there is a shared hope that these efforts will lead to more effective treatment options, offering new hope to patients battling this aggressive disease. Actuate Therapeutics remains dedicated to advancing elraglusib and exploring its potential benefits across different cancer treatment landscapes.