Galera Therapeutics has slammed the emergency button in the wake of a complete response letter from the FDA for a radiotherapy complication drug, jettisoning 70% of its employees as the biotech’s stock sinks.
The FDA ruled that the results of a phase 3 trial of the drug 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,” Galera reported in a postmarket release Wednesday.
Instead, the regulator has decided that a fresh trial will be needed before Galera can resubmit the application for avasopasem, a selective dismutase mimetic.
It’s not the first time that the phase 3 trial, dubbed ROMAN, has caused problems for the company. Back in 2021, Galera announced that avasopasem had flunked the study, before backtracking a couple of months later after it learned that an error by the contract research organization meant the candidate had performed better than previously thought.
Galera had been hoping to see a reduction in incidence of severe oral mucositis (SOM), which occurs in about 70% of patients who receive radiation for head and neck cancer. The condition arises from the epithelial cells lining the gastrointestinal tract breaking down following radiotherapy treatment, causing an inability to eat solid food or drink liquids in its most serious form.
The updated trial data showed avasopasem had in fact produced a 16% reduction in the incidence of SOM compared to placebo, along with a 56% relative reduction in the number of days patients experienced SOM.
Galera made the ROMAN study the centerpiece of its approval application to the FDA in February, arguing that the data showed “statistically significant reductions on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM.”
It clearly wasn’t enough to persuade the regulator. The verdict is likely to have come as a shock to Galera—the company had been busy building out its commercial leadership team in preparation for an anticipated U.S. launch of the drug in 2023.
With those plans in tatters, the biotech plans to request a Type A meeting to “understand the FDA’s rationale for its decision” and discuss the next steps for a resubmission. Galera will “also explore strategic alternatives, including partnering” to ensure the continued development of avasopasem and its other asset rucosopasem, which is in a phase 2 trial for pancreatic cancer.
“This response from the FDA is deeply disappointing for Galera and for patients who suffer from severe oral mucositis,” CEO Mel Sorensen, M.D., said in the release. “We continue to believe in avasopasem’s potential to bring a meaningful benefit to these patients, who currently have no FDA-approved drugs for this debilitating condition.”
“As we explore a potential approval path for avasopasem, we are taking decisive actions to extend our cash runway,” Sorensen added. “Unfortunately, this necessitates reducing our workforce by approximately 70%.”
The drastic measures clearly weren’t enough to appease investors, who sent the company’s stock plunging over 80% to just 41 cents per share in premarket trading from a Wednesday closing price of $2.24.
There had been a lot riding on the approval this year. The biotech ended March with $47.8 million in cash and equivalents, which had only been expected to last into the fourth quarter of 2023. However, while those funds had dropped to $38.8 million by the end of June, the company revealed today, it now expects the money to last into the second quarter of 2024.