Avasopasem manganese (GC4419) is an investigational selective dismutase mimetic drug in development as a radioprotector in combination with radiation therapy (RT), with the goal to reduce side effects from radiation therapy.

  • In preclinical studies, our selective dismutase mimetics significantly reduced immediate and long-term radiation damage to normal tissue in a variety of organs.
  • Avasopasem received Breakthrough Therapy and Fast Track Designations from the U.S. Food and Drug Administration for the reduction of the incidence and severity of radiation induced oral mucositis in head and neck cancer.
  • Avasopasem has completed two randomized trials, both of which met the primary endpoint, to evaluate reduction of severe oral mucositis in patients with head and neck cancer undergoing radiation therapy.1-2

GT-201 Clinical Trial

Avasopasem was studied in a randomized, double-blinded, placebo-controlled 223-patient trial (GT-201) at 44 North American sites. In the trial, avasopasem met the primary endpoint by demonstrating a 92% reduction in median number of days of SOM in the 90 mg treatment arm as compared to placebo.2

 

GT-201 Randomized Clinical Trial results

 

The overall adverse event profile in each of the avasopasem arms was comparable to that in the placebo arm and seemed consistent with the known toxicities of IMRT plus cisplatin when either severe events or events of mild severity grades or grades 3 or greater were considered.  Adverse effects that appeared related to avasopasem were limited to transient, mild-to moderate decreases in blood pressure.2

In this trial, tumor outcomes were maintained at one and two years.3

 

Galera Therapeutics Reports Statistically Significant Results in a 223-Patient Phase 2b Trial of GC4419 for Severe Oral Mucositis in Patients with Head and Neck Cancer; December 18, 2017

 

GTI-4419-301 (ROMAN) Phase 3 Clinical Trial

Avasopasem was also studied in a randomized, double-blinded, placebo-controlled 455-patient Phase 3 clinical trial (GTI-4419-301) at 97 North American sites.  In this trial, avasopasem met the primary endpoint by demonstrating a statistically significant reduction in the incidence of SOM (p = 0.045), as well as in the number of days of SOM (p = 0.002).  Avasopasem was generally well tolerated with similar rates of adverse events in the active and placebo arms.

The Company had previously announced topline results from the ROMAN trial on October 19, 2021. Upon further analysis following the October announcement, an error by the contract research organization was identified in the statistical program. Correction of this error resulted in improved p-values for the primary and secondary endpoints.

Galera Announces Primary Endpoint Met Statistical Significance in Corrected Topline Efficacy Data of Phase 3 ROMAN Trial of Avasopasem; December 14, 2021


Reference:

  1. Anderson CM, Sonis ST, Lee CM, et al. Phase 1b/2a Trial of the Superoxide Dismutase Mimetic GC4419 to Reduce Chemoradiotherapy-Induced Oral Mucositis in Patients With Oral Cavity or Oropharyngeal Carcinoma. Int J Radiat Oncol. Published Online October 16, 2017.
  2. Anderson CM, Lee CM, Saunders DP, et al. Phase IIb, randomized, double-blind trial of GC4419 versus placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer. J Clin Oncol. 2019;37:3256-3265.
  3. Anderson CM, Lee CM, Saunders D, et al. Tumor outcomes of phase IIb, randomized, double-blind trial of GC4419 versus placebo to reduce severe oral mucositis due to concurrent radiotherapy and cisplatin for head and neck cancer. Presented at: Multidisciplinary Head and Neck Cancer Symposium, February 27-29, 2020.

 

Investigational Drug – Not for Commercial Distribution