Actuate Therapeutics (NASDAQ: ACTU) has announced plans to initiate a Phase 1/2 clinical program evaluating the oral tablet dosage form of elraglusib in patients with advanced cancer.
According to Actuate, the goal of the phase 1 portion of the program will be to establish the recommended dose(s) of elraglusib tablets for expansion (RDE) in subsequent development.
In a statement, Dan Schmitt, CEO of Actuate, commented, “With the promising results we have seen with the IV formulation of elraglusib across an array of difficult-to-treat cancers, we are excited to advance the oral tablet formulation in additional indications, including patients with R/R metastatic melanoma. Elraglusib oral tablet will allow us to further explore elraglusib dose using a convenient and easily administered tablet dosage form that will be amenable to evaluation as a single agent. The program builds on encouraging results from our Phase 1 monotherapy clinical trial with the IV formulation, including a remarkable complete response lasting more than 6 years from a patient with highly advanced, highly disseminated, refractory BRAFV600E-mutated metastatic melanoma. We believe the elraglusib oral tablet will have the potential to play an important role in addressing a significant unmet need in the treatment of refractory melanoma as well as other advanced cancer indications.”
