Galera Therapeutics, Inc. (GRTX), a clinical-stage biopharmaceutical company focused on cancer treatment, announced Thursday that it has received a Complete Response Letter or CRL from the U.S. Food and Drug Administration regarding its New Drug Application or NDA for avasopasem manganese (avasopasem). According to the agency, the given trial data is not sufficient, and that results from an additional clinical trial will be required for resubmission.
Galera further said it will take actions to extend its cash runway and continue enrolling its rucosopasem clinical trials. The company plans to reduce its workforce by around 70%.
In pre-market activity on Nasdaq, Galera shares were losing around 82 percent to trade at $0.41.
The NDA was for avasopasem manganese for radiotherapy-induced severe oral mucositis or SOM in patients with head and neck cancer undergoing standard-of-care treatment.
In the CRL, the FDA communicated that “the results from the Phase 3 ROMAN trial together with the supporting data from the GT-201 trial are not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.”
Galera intends to request a Type A meeting with the FDA to understand the agency’s rationale for its decision and discuss next steps to support an NDA resubmission seeking approval of avasopasem.
The company will also explore strategic alternatives, including partnering, for the continued development of avasopasem and rucosopasem.
Regarding its restructuring, Galera said it will wind-down commercial readiness efforts and plans headcount reductions across several departments.
The company will focus resources to define the path forward for avasopasem and to progress the ongoing clinical trials for rucosopasem. Rucosopasem is its second product candidate in development to augment the anti-cancer efficacy of stereotactic body radiation therapy or SBRT for patients with non-small cell lung cancer and locally advanced pancreatic cancer.
Galera estimates that its balance of cash, cash equivalents and marketable securities as of June 30 was $38.8 million. The company now expects that its current cash will be sufficient to support operations into the second quarter of 2024.
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