Galera Therapeutics’ drug for a radiotherapy complication failed to reduce incidences of the debilitating condition called severe oral mucositis during a phase 3 trial.
Avasopasem manganese (avasopasem) was being tested for reducing SOM in patients with locally advanced head and neck cancer during a late-stage trial called ROMAN, according to a Tuesday statement. Galera was hoping to see a reduction in incidence of the condition, which occurs in about 70% of patients who receive radiation for head and neck cancer.
Oral mucositis is a condition in which the epithelial cells lining the gastrointestinal tract break down. The condition causes an inability to eat solid food or drink liquids in its most severe form, meaning patients have to receive supplemental nutrition and hydration. In addition to feeding tubes, patients with SOM may need narcotic analgesics to ease their pain. In some cases, SOM can also be dose-limiting, meaning that subsequent radiotherapy may have to be given in lower doses or delayed altogether.
Instead, avasopasem did not beat placebo in reducing incidences of SOM during the late-stage study, failing the main goal. The drug did, however, spur a 56% relative reduction in the number of days patients experienced SOM. The avasopasem group had eight days while the placebo patients experienced 18 days.
On another secondary endpoint measuring the severity of SOM incidents, avasopasem was also unsuccessful.
Galera’s shares tanked on the news, dropping 69% to $2.29 as of 11 a.m. ET, compared to a prior close of $7.50.
“While the data, as in previous trials, showed reductions in the incidence, duration and severity of SOM, we are surprised and disappointed that the trial did not achieve statistical significance in its primary endpoint,” said Galera President and CEO Mel Sorensen, M.D.
Galera did not say what will become of avasopasem but the biotech is continuing to analyze the results.
Avasopasem was shown in earlier clinical trials to reduce incidences of SOM. The data helped Galera collect $150 million in 2018 to push the therapy through the clinic. Backers included Clarus, Novartis Venture Fund, Novo Ventures and Sofinnova Ventures.
Radiation is thought to cause oral mucositis by raising superoxide radical levels. Galera’s goal is to transform radiotherapy and lessen the debilitating symptoms associated with the life-saving cancer treatment. The biotech has six treatments in its pipeline for uses in head and neck cancer, non-small cell lung cancer (NSCLC) and pancreatic cancer.
The ROMAN trial was the furthest along in phase 3, followed by a pancreatic cancer candidate called GC4711 that Sorensen pointed to as the next big hope. Galera recently initiated a phase 2b combination trial in locally advanced pancreatic cancer for the drug to boost the anti-cancer effects of stereotactic body radiation therapy. Enrollment is also underway for a similar phase 1/2 test in NSCLC.