Significant research grants contributed to early development research and preclinical studies essential to the formation of TRACT Therapeutics, Inc. Additional capital raised from early investors supported the completion of a Phase I Kidney Transplant Clinical Trial.
The Company has recently completed a Series A financing of $15 million to complete two clinical studies and provide the infrastructure to support the trials: 1) “ A Randomized Phase 2 Trial of Adoptive Therapy with Treg Adoptive Cell Transfer (TRACT) to Prevent Rejection in living Donor Kidney Transplant Recipients” (3 arms, 120 subjects) and 2) “A Phase IB Study To Investigate the Safety, Tolerability and Efficacy of Regulatory Cells for the Treatment of Moderate to Severe Active Crohn’s Disease Refractory to Conventional and/or Biological Therapy”. (10 subjects)
Both studies have been approved by the FDA and are expected to start in October 2019.
A Phase I Study in Autoimmune Hepatitis (24 subjects) has been funded through a grant award and will begin enrollment in early 2020.
- An immune system platform therapeutic set to transform physician treatment practices for both autoimmune and transplantation sectors
- A disruptive commercial opportunity to reduce or eliminate lifelong toxic immunosuppressive drugs required to treat patients in autoimmune and transplant sectors; significant economic impact saving billions of United States healthcare dollars each year
- Early clinical success achieved in organ transplantation with value inflection points expected over the next 1-2 years; Phase Ib Clinical Trial in Crohn’s Disease and a Phase I in Autoimmune Hepatitis scheduled for later this year
- Commanding competitive advantages in clinical/safety, manufacturing scalability, clinical reach, market potential and production costs that create extreme requirements for any future competitors
- Two U.S. and PCT patent applications filed for novel method and composition discoveries