Galera : Late-stage Trial Of Avasopasem On Severe Oral Mucositis Fails To Meet Main Goal; Stock Down

(RTTNews) - Galera Therapeutics Inc. (GRTX) said that phase 3 ROMAN trial of avasopasem did not meet its primary endpoint of reduction in the incidence of severe oral mucositis.

In Tuesday pre-market trade, GRTX was trading at $2.00, down $5.40 or 72.973%.

The trial demonstrated relative reduction in all key severe oral mucositis endpoints, including more than halving the median duration. Avasopasem was generally well tolerated with similar rates of adverse events in the active and placebo arms, the company said in a statement.

The trial evaluated avasopasem manganese (avasopasem) for severe oral mucositis in patients with locally advanced head and neck cancer undergoing standard-of-care radiotherapy.

The ROMAN trial is a randomized, double-blind, placebo-controlled trial in 455 patients with locally advanced HNC receiving seven weeks of standard-of-care radiotherapy plus cisplatin. Patients were randomized to one of the two treatment groups (3:2) to receive 90 mg of avasopasem or placebo by infusion on the days they receive their radiation treatment.

Oral mucositis is a side effect of radiation therapy characterized by severe pain, inflammation, ulceration and bleeding of the mouth. In patients with head and neck cancer, radiotherapy is a mainstay of treatment.

The company said it remains committed to its goal of transforming radiotherapy in cancer treatment with its selective dismutase mimetics.