Lisata Therapeutics Inc (NASDAQ:LSTA) said it has completed enrollment in its Phase 2a BOLSTER trial for certepetide, a promising investigational treatment for first-line cholangiocarcinoma (CCA).
The BOLSTER trial, a Phase 2a double-blind, placebo-controlled study conducted across multiple centers in the United States, evaluates certepetide in combination with standard-of-care versus standard-of-care alone for patients with first-line CCA.
In a statement, Lisata said it has expanded the BOLSTER trial to include an arm specifically assessing certepetide's efficacy in second-line treatment in response to the urgent demand to enhance treatment outcomes in second-line CCA.
The company anticipates enrolling the first patient in this arm by the fourth quarter of 2024.
Kristen Buck, Lisata’s chief medical officer, told shareholders that completing enrollment in the first-line CCA cohort of the BOLSTER trial is a “significant accomplishment” for the company and a major step forward in the development of certepetide for CCA.
“This achievement underscores the dedication and enthusiasm of everyone involved in supporting the study, both internally and externally, as well as the promise of certepetide as a first-line treatment option for CCA,” Buck said in a statement.
Top-line data from the trial is anticipated by mid-2025.