BTIG launched coverage of Galera Therapeutics (NASDAQ:GRTX) with a “buy” rating and $30 price target. The stock closed at $12.53.
Galera is focused on developing superoxide dismutase mimetics, first‐in‐class medicines that have the potential to protect patients from radiotherapy-induced toxicities, and enhance the efficacy of radiotherapy itself, writes analyst Robert Hazlett.
Galera’s lead asset, GC4419, is an IV superoxide dismutase (SOD) mimetic, in a Phase 3 program for the reduction of severe oral mucositis (SOM) in head and neck cancer patients who are undergoing radiotherapy.
Mr. Hazlett said GC4419 showed robust efficacy in a Phase 2b study, gaining breakthrough designation from FDA. In addition, GC4419 had no material effect on the effectiveness of radiation in these head and neck cancer patients, with no difference seen in overall survival, progression free survival, and other measures though two years of follow up, he said.
Galera also is examining GC4419 in a Phase 2a study to assess its combination with intensity-modulated radiation therapy and chemotherapy in patients with lung cancer. The study’s primary endpoint is to assess the efficacy of GC4419 in reducing Grade 2 or higher esophagitis, a serious condition similar to SOM involving inflammation of the esophagus. Galera expects to begin enrollment in the first half of 2020, and will pursue a compendia listing strategy for this use, Mr. Hazlett said.