WALTHAM, Mass. — Fortitude Biomedicines, Inc. said it is advancing a first-in-class T-cell targeting bispecific antibody for the potential treatment of axial spondyloarthritis (AxSpA), while appointing Rahul Patel, M.D., FACR, as senior vice president of clinical development to help steer the program toward the clinic.
The Waltham-based biopharmaceutical company, which focuses on immune cell–targeting biologics and antibody-drug conjugates for autoimmune diseases and cancer, said its lead AxSpA candidate has demonstrated promising preclinical activity. The therapy is designed to selectively suppress disease-driven T-cell signaling pathways, with early data showing durable responses in animal models.
The company expects the program to enter clinical trials in the first half of 2027.
AxSpA is a chronic inflammatory disease that affects the spine and sacroiliac joints, often beginning before age 40. The condition is marked by persistent back pain, stiffness, and inflammation at tendon and ligament attachment sites. Over time, it can lead to structural damage and long-term disability, affecting quality of life and productivity.
More than 1.8 million people in the U.S. and over 50 million worldwide are affected by AxSpA, according to the company, with more than half of patients unable to achieve adequate disease control using current therapies.
“With more than 50 percent of AxSpA patients unable to achieve adequate disease control, there continues to be a large unmet need in management of this disease. We are excited with the promising preclinical activity seen with our lead program,” said Jesse Chen, M.D., president and CEO of Fortitude.
Chen added that Patel’s appointment strengthens the company’s clinical leadership as it advances its pipeline.
“As a board-certified rheumatologist and experienced drug developer, Rahul’s addition to the leadership team will provide critical support in the strategic clinical advancement of our therapeutic programs,” he said.
Patel said he aims to help move the company’s pipeline into clinical-stage development.
“I am pleased to join Fortitude, to coordinate with exceptional team members and to advance an innovative pipeline of therapeutics,” Patel said. “There remains a significant unmet need in rheumatology, including in AxSpA, for therapies that can advance the field further and potentially offer a higher bar of efficacy. I look forward to working with the Fortitude team as we advance to a clinical stage biotech ahead.”
