Pacibekitug shows promise in Phase 2 trial for heart disease

Published 20/05/2025, 12:38
Pacibekitug shows promise in Phase 2 trial for heart disease

NEW YORK - Tourmaline Bio, Inc. (NASDAQ: TRML), a clinical-stage biotech company with a market capitalization of $427.2 million, revealed positive results from its Phase 2 TRANQUILITY trial of pacibekitug, an investigational IL-6 inhibitor, in patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD). According to InvestingPro data, analysts maintain a strong buy consensus on the stock, with price targets ranging from $35 to $70. The study demonstrated significant reductions in hs-CRP, a biomarker associated with cardiovascular risk. While the clinical results appear promising, InvestingPro analysis indicates the company is rapidly burning through cash, though it maintains more cash than debt on its balance sheet.

The TRANQUILITY trial, which began with a focus on atherosclerotic cardiovascular disease (ASCVD), showed that all dosing arms of pacibekitug achieved rapid, substantial, and sustained decreases in hs-CRP levels compared to placebo, with the 50 mg quarterly dose arm showing more than 85% reduction from baseline. These results were statistically significant (p

Safety data from the trial indicated that the incidence of adverse events and serious adverse events in the pacibekitug groups were similar to those observed in the placebo group. The most common adverse events in the pacibekitug-treated participants included urinary tract infection, COVID-19, dizziness, and viral upper respiratory tract infection.

Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital and Chair of Tourmaline’s Cardiovascular Scientific Advisory Board, emphasized the potential of pacibekitug for cardiovascular risk reduction and the importance of testing it in future Phase 3 trials.

The TRANQUILITY trial involved 143 participants, with 126 in the primary analysis population. The study was designed as a multicenter, randomized, double-blind, placebo-controlled trial, with patients receiving either pacibekitug or placebo for six months and then followed for an additional six months.

Based on the strength of the data, Tourmaline plans to accelerate the development of pacibekitug for ASCVD and abdominal aortic aneurysm (AAA), with further details on a potential Phase 3 cardiovascular outcomes trial and a Phase 2 proof-of-concept trial in AAA to be provided later in 2025.

This press release statement serves as the source for the information reported in this article.

In other recent news, Tourmaline Bio has been actively engaged in its Phase 2 TRANQUILITY trial, focusing on the drug candidate pacibekitug for patients with chronic kidney disease and elevated high-sensitivity C-reactive protein levels. The company reported a net loss of $22.2 million for the fourth quarter of 2024, slightly exceeding the estimated loss. Analysts have shown varying degrees of optimism regarding Tourmaline Bio’s prospects. H.C. Wainwright raised its price target to $50, maintaining a Buy rating, while Truist Securities lowered its target to $63 but also retained a Buy rating, citing the potential of pacibekitug in treating atherosclerotic cardiovascular disease.

Cantor Fitzgerald reiterated its Overweight rating, highlighting the drug’s overlooked potential for abdominal aortic aneurysm, suggesting it could generate significant revenue. Meanwhile, Chardan Capital Markets set a $70 price target, reflecting confidence in the company’s growth prospects, particularly with pacibekitug’s potential applications. The TRANQUILITY trial has enrolled 143 patients across various dosing arms, with primary endpoints focusing on changes in inflammation indicators. These developments indicate a strategic focus on advancing pacibekitug’s clinical trials and exploring its potential across multiple conditions.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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