Marina Biotech Completes Enrollment in Phase 1b/2a Clinical Trial for Familial Adenomatous Polyposis (FAP) Treatment

Strategic Insights -

Marina Biotech, a leading RNAi-based drug discovery and development company, has announced the completion of enrollment in the first cohort of its START-FAP, Phase 1b/2a clinical trial with CEQ508. This milestone marks a significant step forward in the development of a novel therapeutic agent for Familial Adenomatous Polyposis (FAP), a hereditary condition that occurs in approximately 1:10,000 persons worldwide.

Key Takeaways:

  • Marina Biotech has completed enrollment in the first cohort of its START-FAP, Phase 1b/2a clinical trial with CEQ508 for the treatment of Familial Adenomatous Polyposis (FAP).
  • The trial is an open-label, escalating-dose study of single daily doses of CEQ508, which will be administered as an oral, daily drink for 28 days.
  • The study drug, CEQ508, is being developed as an orally administered treatment to reduce the levels of beta-catenin protein in the epithelial cells of the small and large intestine.
  • Marina Biotech has completed enrollment for the first group in the Dose Escalation Phase, which consists of three patients receiving the starting and lowest dose level of 1x10^8 colony forming units (cfu)/day.
  • The global patent estate for the tkRNAi platform includes issued or allowed patents in Korea, Australia, and countries throughout Europe, and pending patent applications in the U.S., Canada, and Japan.
  • The tkRNAi platform was developed and filed by the Beth Israel Deaconess Medical Center (BIDMC) and Marina Biotech has an exclusive license to the platform.
  • Marina Biotech's pipeline currently includes a clinical program in Familial Adenomatous Polyposis (a precancerous syndrome), and two preclinical programs in hepatocellular carcinoma and bladder cancer.

Statistics:

  • Approximately 1:10,000 persons worldwide are affected by Familial Adenomatous Polyposis (FAP).
  • 95% of FAP patients develop polyps by age 35, and most will experience adverse effects including increased risk of bleeding and the potential for anemia.
  • CEQ508 will be administered daily in an oral suspension for 28 consecutive days.
  • 4 dose-escalating cohorts are expected to be enrolled in the trial.

Sources:

  • Marina Biotech, Inc.
  • Marketwire
  • Beth Israel Deaconess Medical Center (BIDMC)
  • SEC Filings for Marina Biotech, Inc.