- Private biotech Galera Therapeutics Inc. on Monday said a Phase 2b study of its lead drug candidate succeeded, showing the experimental treatment reduced the duration of severe oral mucositis in certain cancer patients compared to those receiving placebo.
- Severe oral mucositis, or SOM, is a common side effect of chemoradiation, causing pain and making it difficult to eat or drink. Galera tested its drug, known as GC4419, specifically in patients with head or neck cancers.
- "Up to 70% of patients with head and neck cancer receiving radiotherapy experience severe oral mucositis, and GC4419 has the potential to become an important treatment in a therapeutic area that has not seen meaningful innovation," said Galera CEO J. Mel Sorensen, in a Dec. 18 statement.
Galera is backed by a number of major venture investors, including Sofinnova Ventures, Novartis Venture Fund and Novo Ventures. Last December, the company secured $15 million in funding from Sofinnova, pushing up its total Series B financing to $57 million.
Clinically, Galera is focused on treatments to be used in supportive care of cancer patients, including GC4419 and an unnamed, early-stage candidate for radiation toxicities.
In the Phase 2b study, a 90 mg dose of GC4419 shortened the duration of SOM by 92%, a statistically significant result compared to those patients receiving placebo. On a secondary measure, the drug candidate lowered the incidence of SOM through completion of radiotherapy by 34%.
Treatment side effects weren't detailed in full, but the company said the drug was well-tolerated.
Galera divided the 223-patient study into three groups: two treatment arms receiving either 30 mg or 90 mg doses of GC4419 infused on days patients received radiation treatment and a group of patients who were given placebo infusion.
The company did not disclose results from the 30 mg arm, but noted that the reduction seen from the 90 mg group was dose-dependent.
In June, Galera said a positive result from the Phase 2b study would help the company design a planned Phase 3 program.