Pictured: FDA sign in its headquarters/iStock, Grandbrothers
The FDA rejected on Wednesday Galera Therapeutics’ avasopasem manganese, which the company was proposing as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer.
Galera shares fell 83% in after-hours trading in response to the FDA’s rejection.
In its Complete Response Letter, the regulator said that Galera’s data were “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.” The FDA noted that it will need results from an additional trial if the company wants to file a resubmission.
The New Drug Application for avasopasem manganese included data from the Phase III ROMAN study, topline data from which showed that treatment with Galera’s candidate significantly reduced the incidence of radiotherapy-induced severe oral mucositis (SOM). The company supported these findings with results from the Phase IIb GT-201 trial in which avasopasem manganese also led to lower SOM burden.
Galera CEO Mel Sorensen called the FDA’s decision “deeply disappointing” in a statement. Nevertheless, the biotech will request a Type A meeting with the regulator to better understand the rejection and to identify potential next steps for its candidate.
Avasopasem manganese is a selective dismutase mimetic. It works by converting superoxide into hydrogen peroxide, which helps sensitize cancer cells to radiation while also protecting healthy cells. This mechanism of action could be beneficial to head and neck cancer patients suffering from radiation-related SOM, for whom there are currently no approved therapeutic options.
Galera will explore a path forward for avasopasem manganese, but the company also needs to secure its cash runway to continue operations. On Wednesday, the biotech announced a sweeping restructuring plan that will involve job cuts for approximately 70% of its workforce across several departments. The realignment will also include the wind-down of its commercial readiness efforts.
The initiative will allow Galera to find the best way forward for avasopasem manganese and focus its resources on the clinical trials of its second candidate rucosopasem, which is being developed to augment the anti-cancer effects of stereotactic body radiation therapy in non-small cell lung cancer and advanced pancreatic cancer.
As of June 30, Galera estimated a total of approximately $38.8 million in cash, cash equivalents and marketable securities, which will keep the company afloat through the second quarter of 2024.