Galera halts rucosopasem trials as it continues to weigh options

2023-10-31

临床2期临床3期临床终止

Shares in Galera Therapeutics tumbled as much as 54% on Tuesday after it announced a decision to halt a pair of cancer trials of the selective dismutase mimetic rucosopasem. The company said it is stopping the Phase IIb GRECO-2 trial of the drug in patients with locally advanced pancreatic cancer, as well as the Phase I/II GRECO-1 trial of rucosopasem in patients with non-small cell lung cancer, following a futility analysis of GRECO-2.

"In light of our current resources and the results of the futility analysis, we have made the difficult decision to discontinue both GRECO trials. We will analyse the data collected to date to determine next steps for the asset," said CEO Mel Sorensen.

The futility analysis of the GRECO-2 trial showed that it was "unlikely to succeed as designed," according to Galera. The study was evaluating rucosopasem versus placebo in combination with stereotactic body radiation therapy in patients with locally advanced pancreatic cancer. The primary endpoint was overall survival and it was designed to enrol 220 patients with final analysis at 120 deaths. The trial enrolled 177 patients to date, and the futility analysis was conducted based on 35 deaths with a data cut-off of October 9.

Additional trial request for SOM drug

Meanwhile, Galera also said it received official minutes from a recent meeting with the FDA in which the regulator reiterated the need for an additional Phase III trial to support resubmission of the company’s marketing application for avasopasem to treat radiotherapy-induced severe oral mucositis (SOM).

"We are disappointed that the FDA did not find the data from our Phase IIb GT-201 and Phase III ROMAN trials sufficient" for the approval of avasopasem, said Sorensen, adding that "after discussing the data with the FDA, it is clear that their position is another Phase III trial is required."

The FDA had issued a complete response letter to Galera in August regarding the application for avasopasem to treat radiotherapy-induced SOM in patients with head-and-neck cancer undergoing standard-of-care treatment. At that time, Galera said it would reduce its workforce by 70% as part of a broader restructuring to extend its cash runway.

Future in doubt

The company believes that the decision to halt the rucosopasem trials will enable it to conserve cash while it continues to assess potential strategic alternatives, which may include a merger, sale, divestiture of assets, licensing or other strategic transaction. If unable to undertake any strategic alternative, Galera warned that it may be required to cease operations.

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