Benzinga - by Vandana Singh, Benzinga Editor.
Galera Therapeutics Inc (NASDAQ: GRTX) received official meeting minutes from the Type A meeting with the FDA held last month.
The FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced severe oral mucositis (SOM).
In August, Galera received an FDA Complete Response Letter for avasopasem, citing that the results from the Phase 3 ROMAN trial, together with the supporting data from the GT-201 trial, are not sufficient to establish substantial evidence of avasopasem's effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.
FDA stated that results from an additional clinical trial will be required for resubmission.
The company also decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) in patients with locally advanced pancreatic cancer and the Phase 1/2 GRECO-1 trial of rucosopasem in patients with non-small-cell-lung-cancer, following futility analysis of the GRECO-2 trial.
The company says the move will help it conserve cash while assessing potential strategic alternatives.
In the Type A Meeting minutes, the FDA reiterated that results from an additional Phase 3 trial would be required to support the resubmission of the company's marketing application for avasopasem in radiotherapy-induced SOM.
To optimize its resources, the company conducted a futility analysis of the GRECO-2 trial to assess the likelihood of a successful outcome.
The analysis indicated that the trial was unlikely to succeed as designed. Overall survival is the trial's primary endpoint. The trial was designed to enroll 220 patients with final analysis at 120 events (deaths). The trial has enrolled 177 patients to date.
Galera estimates that its balance of cash, cash equivalents, and short-term investments as of September 30, 2023, was $28.4 million.
Price Action: GRTX shares are down 51.90% at $0.10 on the last check Tuesday.
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