MALVERN, PA — In a significant corporate update, Chester County-based biotechnology firm Baudax Bio, Inc. (NASDAQ: BXRX) this week announced plans to initiate the clinical development of its groundbreaking therapy, TI-168. This follows shareholder approval of corporate actions relating to Baudax’s acquisition of TeraImmune in June 2023.
The company is now readying to begin its Phase 1/2a clinical study of TI-168 in patients with Hemophilia A and FVIII inhibitors, with an estimated start date in Q1 2024. This next-generation therapy is designed to address the complications associated with Hemophilia A reliably and effectively.
Baudax Bio’s President and CEO, Gerri Henwood, expressed her satisfaction with the broad support received at a recent special shareholder meeting. She stated, “This combination, which brings together TeraImmune’s research expertise with Baudax’s drug development experience for the initiation of clinical development of TI-168, represents the best path forward to create shareholder value.”
Stewart Mc Callum, MD, Consulting Chief Medical Officer for Baudax, further explained the significance of TI-168. He said, “TI-168 is a TCR Treg designed to eliminate autoantibodies to Factor VIII in Hemophilia A patients, which significantly complicates the management of Hemophilia A.”
The product candidate has previously had an IND filed seeking to treat human subjects that received regulatory clearance, and has also recently been granted Orphan Drug Designation by the FDA. The trial features an open label design, allowing for early visibility on tolerability and initial efficacy data.
Henwood concluded, “This trial represents the first time that TCR Tregs will be in a human clinical trial, and will seek to establish a dose where TI-168 eliminates T-cell and B cell mediated production of autoantibodies, demonstrating the potential of TI-168 to make Hemophilia A much less complicated for patients with inhibitors to manage.”
This new clinical development marks a significant step forward in the treatment of Hemophilia A, promising to offer substantial improvements to patient quality of life. It also represents a milestone for Baudax Bio, bolstering its position as a leading biotechnology company in Chester County and beyond.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.