Actuate Therapeutics has set its sights on getting elraglusib approved for pancreatic cancer after the glycogen synthase kinase‐3 beta (GSK-3β) drug showed a three-month survival increase in a phase 2 study.
The Texas- and Ireland-based biotech evaluated the therapy in a trial of 286 patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who received either elraglusib and chemotherapy or chemotherapy alone. The elraglusib patients saw a median overall survival of 10.1 months, compared to 7.2 months for the comparator cohort, hitting the study’s primary endpoint, according to a May 31 release.
The data, which Actuate unveiled at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago over the weekend, also showed that the 12-month survival rate for elraglusib patients was 44.1%—double the 22.3% rate for those on chemotherapy only.
Overall response rates were 29% and 21.8%, respectively, for the two groups, while there was also a slight improvement in median progression-free survival at 5.6 months compared to 5.1 months.
Adverse events were similar between the two cohorts, said Actuate. Most treatment-related adverse events were grades 1-2, with two-thirds of patients experiencing transient visual impairments that were reversible.
While cases of neutropenia—low levels of a type of white blood cell—reached grade 3 “or higher,” the rates of these events or sepsis were similar across both arms of the study, the biotech stressed.
“Combined with a manageable safety profile and strong emerging mechanistic insights, these results reinforce the transformative potential of our GSK-3β inhibitor program,” Actuate CEO Daniel Schmitt said in the release.
“Based on the clear clinical benefit and well-tolerated safety profile, we intend to engage with the FDA and EMA in the second half of this year to align on a path to registration,” Schmitt added. “We believe this enables us to move rapidly towards commercialization and delivery of this first-in-class therapy to patients with an urgent unmet need.”
Actuate went public last summer via a scaled-back $22.4 million IPO. The company’s stock hovered around its $8 debut price until good news about elraglusib’s prospects in recent months saw the shares reach a closing price on Friday of $11.90. The stock has since risen up to $13.74 in premarket trading Monday.
Pancreatic cancer is a notoriously tough indication to treat that has seen few advances. Elraglusib is designed to bind to GSK-3β, disrupting cancer pathways associated with the invasion of tumor cells and resistance to chemotherapeutic agents and radiation. Preclinical tests suggested the intravenous small molecule could have an impact on diseases like urothelial cancer and renal cell carcinoma, leading Actuate to take the candidate into human studies in 2018.