Tourmaline Bio is making significant strides in its pacibekitug development program, with a reinforced focus on cardiovascular inflammation. The company announced key clinical and strategic updates, including the over-enrollment of its Phase 2 TRANQUILITY trial and the expansion of its Cardiovascular Scientific Advisory Board.
TRANQUILITY Trial Update
The Phase 2 TRANQUILITY trial, designed to evaluate quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease, has surpassed its enrollment target. A total of 143 patients have been enrolled, exceeding the originally anticipated 120 patients. Topline data from this trial are expected in the second quarter of 2025. The TRANQUILITY trial is a crucial step in Tourmaline's clinical development program for pacibekitug in treating atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. Positive results from TRANQUILITY are expected to position Tourmaline for a Phase 3 trial in ASCVD.
Cardiovascular Scientific Advisory Board Expansion
Tourmaline has expanded its Cardiovascular Scientific Advisory Board (CV SAB) with the appointment of Deepak L. Bhatt, MD, MPH, MBA, as Chair, and Dipender Gill, MD, PhD, as a member. Dr. Bhatt, Director of the Mount Sinai Fuster Heart Hospital, brings extensive clinical trial expertise. Dr. Gill, CEO of Sequoia Genetics, provides deep translational insight to Tourmaline’s strategic focus.
New Indication: Abdominal Aortic Aneurysm
Tourmaline has nominated abdominal aortic aneurysm (AAA) as an additional indication for pacibekitug within its cardiovascular inflammation disease focus. The company plans to provide further details on a planned Phase 2 proof-of-concept trial in AAA following the topline results from the Phase 2 TRANQUILITY trial in Q2 2025. This expansion underscores Tourmaline's commitment to addressing inflammation-driven cardiovascular diseases.
Thyroid Eye Disease Program Update
Given Tourmaline’s emphasis on cardiovascular inflammation, the initiation of a Phase 3 trial in thyroid eye disease (TED) will depend on the results from the ongoing Phase 2b spiriTED trial. Topline data from the Phase 2b spiriTED trial are expected in the second half of 2025, at which time Tourmaline will provide additional information on its future development plans in TED.
Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline Bio, stated, “We continue to be laser-focused on our development efforts for pacibekitug in order to maximize the potential of this program. Today’s updates, including the over-enrollment of our TRANQUILITY trial, the expansion of our Cardiovascular Scientific Advisory Board, and the addition of a new indication, reflect the strength of our science, the caliber of our team, and our commitment to redefining standards of care for patients worldwide.”
Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. It has been studied in approximately 450 participants across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED).
