CHICAGO, IL and FORT WORTH, TX – Actuate Therapeutics, Inc. (Actuate), a clinical stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for elraglusib for treatment of patients with pancreatic cancer. Elraglusib (9-ING-41) is Actuate’s proprietary small molecule glycogen synthase kinase-3 beta (GSK-3β) inhibitor which is being developed for adults and children with advanced refractory cancers.
“We are pleased with the FDA’s decision to grant Orphan Drug Designation to elraglusib for the treatment of pancreatic cancer. Pancreatic cancer remains an area of high unmet medical need, with less than 10% survival in the US at 5 years. The Orphan Drug Designation furthers our ability to advance development and regulatory interactions with the FDA to bring elraglusib to patients with this highly lethal malignancy”, said Daniel Schmitt, President & CEO.
Actuate first enrolled patients with advanced pancreatic cancer on a phase 2 study of 9-ING-41 combined with gemcitabine/nab-paclitaxel, as an additional arm of the phase 1/2 1801 trial of 9-ING-41, (NCT03678883, EudraCT#:2018-003739-32).
“Based on the promising final data from our completed single arm phase 2 study, we have initiated an open label, randomized phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel for the frontline treatment of patients with metastatic pancreatic cancer” said Dr. Andrew Mazar, Actuate’s Chief Operating Officer. “Additional investigator-led phase 2 studies for the front line treatment of patients with advanced pancreatic cancer in combination with a checkpoint inhibitor (NCT05239182) and in patients with metastatic pancreatic cancer in combination with FOLFIRINOX (NCT05077800) are also in progress, emphasizing our commitment to developing elraglusib for the pancreatic cancer population .”
The FDA’s Orphan Drug Designation FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.
About Actuate Therapeutics, Inc.
Actuate is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for high impact cancers and inflammatory diseases. Actuate’s lead drug, elraglusib (a novel GSK-3 inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy. Elraglusib is also emerging as a mediator of anti-tumor immunity through the inhibition of multiple immune checkpoints and the regulation of immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com
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