A Second Look At Galera Therapeutics

Shares of Galera Therapeutics Inc. (GRTX) skyrocketed 95% on Tuesday, thanks to corrected results from its ROMAN trial.

The ROMAN trial is a phase III study comparing the company’s lead drug candidate Avasopasem against placebo for the treatment of severe oral mucositis in patients with locally advanced head and neck cancer undergoing standard-of-care radiotherapy.

Avasopasem, also known as GC4419, is a highly-selective small molecule mimetic of superoxide dismutase (SOD) that rapidly and selectively converts superoxide to hydrogen peroxide and oxygen in order to protect normal tissue from radiation therapy-induced damage.

Approximately 42,000 head and neck cancer patients undergo standard-of-care radiotherapy every year in the U.S. and are at risk of experiencing severe oral mucositis. There are no FDA approved drugs to reduce the incidence or duration of severe oral mucositis in solid tumors.

The company had previously announced the ROMAN trial results on Oct.19, 2021, wherein it was reported that the primary endpoint of reduction in incidence of severe oral mucositis (SOM) did not achieve statistical significance. The news sent the company’s stock plunging more than 70% to $2.25 that day.

Upon further analysis, an error by the contract research organization (CRO) was discovered in the statistical program and as per the amended results, reported yesterday, the primary endpoint in reducing the incidence of severe oral mucositis has achieved statistical significance.

The incidence of severe oral mucositis (SOM) in the Avasopasem treatment group was 54% and that in the placebo group was 64%. The number of days of SOM in the Avasopasem treatment group was 8 days and in the placebo group it was 18 days.

According to the trial results, Avasopasem is associated with a 16% reduction in the incidence of severe oral mucositis compared to placebo, 56% relative reduction in the duration of severe oral mucositis and a 27% relative reduction in severity.

The results from a single-arm phase IIa trial of Avasopasem in Europe for radiotherapy-induced severe oral mucositis in patients with head and neck cancer undergoing standard-of-care radiotherapy plus Cisplatin, dubbed EUSOM, have also been found to be in line with the ROMAN trial results. In EUSOM, the incidence of severe oral mucositis was 54.5% and the median number of days of SOM was 9 days.

The company plans to discuss the Avasopasem data in severe oral mucositis with the FDA in 2022.

Avasopasem is also being evaluated for its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer and a phase IIa trial in this indication, dubbed AESOP, is underway. The company expects to report topline data from the AESOP trial in the first half of 2022.

Also in the pipeline is Rucosopasem, Galera’s second dismutase mimetic product candidate, which in combination with stereotactic body radiation therapy (SBRT), is under a phase IIb trial in patients with locally advanced pancreatic cancer. This trial, dubbed GRECO-2, is enrolling patients.

Rucosopasem is also being studied in a phase I/II trial in combination with SBRT in patients with non-small cell lung cancer, dubbed GRECO-1, with initial data anticipated in the first half of 2022.

Cash position:

As of September 30, 2021, Galera had cash, cash equivalents and short-term investments of $88.7 million.

Galera made its debut on the Nasdaq Global Market on November 7, 2019, offering its shares at a price of $12 each.

GRTX has traded in a range of $1.19 to $12.99 in the last 1 year. The stock closed Tuesday’s trading at $2.70, up 95.65%.

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