TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

Actuate Therapeutics' Elraglusib Receives FDA Orphan Drug Designation for Pancreatic Cancer Treatment

Wednesday, August 02, 2023

Actuate Therapeutics, Inc. (Actuate), a clinical-stage biopharmaceutical company, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for elraglusib as a treatment for patients with pancreatic cancer. Elraglusib, also known as 9-ING-41, is Actuate's proprietary small molecule glycogen synthase kinase-3 beta (GSK-3β) inhibitor, being developed to target advanced refractory cancers in both adults and children.

Daniel Schmitt, President & CEO of Actuate, expressed satisfaction with the FDA's decision to grant Orphan Drug Designation to elraglusib for pancreatic cancer treatment. Pancreatic cancer remains an area with a significant unmet medical need, where the survival rate in the U.S. is less than 10% at 5 years. The designation will aid Actuate in advancing the development and regulatory interactions with the FDA to make elraglusib available to patients with this highly lethal malignancy.

Actuate had previously enrolled patients with advanced pancreatic cancer in a phase 2 study of 9-ING-41 combined with gemcitabine/nab-paclitaxel as part of the phase 1/2 1801 trial of 9-ING-41 (NCT03678883, EudraCT#:2018-003739-32).

Based on the promising results from their completed single-arm phase 2 study, Actuate has initiated an open-label, randomized phase 2 study of elraglusib in combination with gemcitabine/nab-paclitaxel for frontline treatment of patients with metastatic pancreatic cancer. Additionally, they have investigator-led phase 2 studies underway, exploring elraglusib for front-line treatment of advanced pancreatic cancer in combination with a checkpoint inhibitor (NCT05239182) and in patients with metastatic pancreatic cancer in combination with FOLFIRINOX (NCT05077800). These efforts underscore Actuate's commitment to developing elraglusib to address the needs of the pancreatic cancer population.

The FDA's Orphan Drug Designation is granted to investigational therapies that address rare medical diseases or conditions affecting fewer than 200,000 people in the United States. This designation 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.

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit