Trillium Therapeutics will begin a phase I clinical trial of its experimental drug, TTI-1612, in patients with interstitial cystitis/bladder pain syndrome (IC/BPS). The company has recently received a No Objection Letter to its Clinical Trial Application from Health Canada's Biologics and Genetic Therapies Directorate. The single ascending dose trial, which will be conducted at multiple sites across southern Ontario, will evaluate the safety and tolerability of TTI-1612 in IC/BPS patients.
IC/BPS, also known as Painful Bladder Syndrome, is a chronic, debilitating and poorly treated bladder disease affecting millions of people. The disease is believed to develop as a result of dysfunction in the protective epithelial layer lining the bladder. Working with an advisory group of urologists, Trillium has assembled a development program aimed at addressing the underlying cause of IC/BPS. TTI-1612, a locally-delivered recombinant growth factor, is being developed to correct the dysfunction and restore the bladder epithelium to a normal, healthy state.