FDA has granted Orphan Drug Designation (ODD) to Actuate Therapeutics for elraglusib, a novel glycogen synthase kinase-3 beta (GSK-3β) inhibitor, for the treatment of soft tissue sarcoma (STS).
This designation was intended to support the development of elraglusib for a rare disease, which includes STS, and offered potential regulatory benefits, such as tax credits, orphan drug exclusivity, and potential priority review.
Elraglusib was evaluated in multiple clinical trials, including a Phase II trial offering hope for advanced STS patients.
Daniel Schmitt, President & CEO of Actuate, acknowledged the FDA’s ODD for elraglusib, emphasizing its potential to address unmet needs in STS treatment.
He noted that elraglusib has shown a favorable safety profile and antitumor activity in various solid tumors, including melanoma.
Dr. Steven D. Reich, Senior VP of Clinical Development at Actuate, acknowledged the challenge of treating STS and emphasized the unmet need for metastatic patients.
He noted that preclinical studies showed elraglusib’s significant effect in inducing cell apoptosis and enhancing chemotherapy.
Source: Actuate Receives FDA Orphan Drug Designation for Elraglusib for Treatment of Soft Tissue Sarcomas
https://www.globenewswire.com/news-release/2024/09/11/2944428/0/en/Actuate-Receives-FDA-Orphan-Drug-Designation-for-Elraglusib-for-Treatment-of-Soft-Tissue-Sarcomas.html
