Galera Therapeutics, a leading biopharmaceutical company, recently disclosed receiving official meeting minutes from a Type A meeting with the Food and Drug Administration (FDA) held last month. The FDA reiterated the imperative need for an additional Phase 3 trial of avasopasem manganese (avasopasem) to address radiotherapy-induced severe oral mucositis (SOM). In response to this development, Galera Therapeutics’ stock experienced a significant decline.
At the time of this publication, Galera Therapeutics Inc stock (GRTX) has witnessed a decline.
Galera Therapeutics Inc
Current Price: $0.10
Change : -0.12
Change (%): (-55.02%)
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This announcement comes after Galera encountered a setback in August when it received an FDA Complete Response Letter for avasopasem. The letter cited that the results from the Phase 3 ROMAN trial, combined with supporting data from the GT-201 trial, were insufficient to establish substantial evidence of avasopasem’s efficacy and safety in reducing severe oral mucositis for patients with head and neck cancer. The FDA made it clear that results from an additional clinical trial would be necessary for resubmission.
In light of this, Galera has made the strategic decision to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) for patients with locally advanced pancreatic cancer, as well as the Phase 1/2 GRECO-1 trial of rucosopasem for patients with non-small-cell-lung-cancer. This decision followed a futility analysis of the GRECO-2 trial, which indicated that the trial was unlikely to achieve its objectives. The primary endpoint of the trial was overall survival, with an enrollment goal of 220 patients and a final analysis at 120 events (deaths). To date, the trial has enrolled 177 patients.
Galera justified this move as a means to conserve financial resources while exploring potential strategic alternatives. As of September 30, 2023, the company estimates its balance of cash, cash equivalents, and short-term investments to be approximately $28.4 million.
In the recently disclosed Type A Meeting minutes, the FDA reiterated its stance that results from an additional Phase 3 trial are indispensable for supporting the resubmission of Galera’s marketing application for avasopasem in cases of radiotherapy-induced SOM.
The setback faced by Galera Therapeutics highlights the stringent regulatory standards set by the FDA in evaluating the efficacy and safety of pharmaceutical treatments. The company now faces the challenge of designing and executing an additional Phase 3 trial for avasopasem, with hopes of ultimately securing approval for its potential benefits in addressing radiotherapy-induced severe oral mucositis.
