Tourmaline Bio Initiates Clinical Development of TOUR006 for Cardiovascular Diseases with First Patient Dosed in Phase 2 TRANQUILITY Trial
Tourmaline Bio has dosed the first patient in its Phase 2 TRANQUILITY trial for TOUR006, a monoclonal antibody targeting IL-6 to treat atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular conditions. This randomized, double-blind, placebo-controlled trial involves patients with high inflammatory risk and chronic kidney disease. The trial aims to assess the drug's safety, pharmacokinetics, and pharmacodynamics, with results anticipated in the first half of 2025. If successful, TOUR006 could advance to Phase 3 by 2025, offering quarterly subcutaneous dosing and potentially positioning itself as a best-in-class treatment for ASCVD and related conditions.
- First patient dosed in Phase 2 TRANQUILITY trial for TOUR006, marking a significant milestone.
- Trial aims to evaluate safety, pharmacokinetics, and pharmacodynamics in patients with inflammatory risk and chronic kidney disease.
- Topline data expected in the first half of 2025 could advance TOUR006 to Phase 3 readiness.
- Potential for quarterly subcutaneous dosing offers ease of use and consistent patient adherence.
- Six prior Phase 1 and Phase 2 studies of TOUR006 informed the design of the TRANQUILITY trial.
- TOUR006 aims to address both cardiovascular diseases and autoimmune disorders.
- Results not expected until the first half of 2025, a long timeline for potential investors.
- The trial is randomized, double-blind, and placebo-controlled, which may present challenges in proving efficacy.
- Dependence on previous Phase 1 and Phase 2 data may not fully predict Phase 2 success.
- High-risk patient population may complicate trial outcomes and data interpretation.
Insights
The initiation of Tourmaline Bio's Phase 2 TRANQUILITY trial for TOUR006 marks a significant step in the development of new treatments for cardiovascular diseases. By focusing on the safety, pharmacokinetics (how the drug moves through the body) and pharmacodynamics (the effects of the drug on the body), this trial aims to address unmet needs in treating atherosclerotic cardiovascular disease (ASCVD) and chronic kidney disease (CKD).
One of the standout features is the use of a long-acting, fully human, anti-IL-6 monoclonal antibody. IL-6 is a protein that plays a role in inflammation, which is linked to cardiovascular diseases. The potential for quarterly subcutaneous dosing is noteworthy, simplifying treatment regimens, which could improve patient adherence and outcomes.
However, while early-stage results are promising, it's important to remember that the success of Phase 2 does not guarantee Phase 3 outcomes. Investors should be cautious and monitor subsequent data releases closely.
Tourmaline Bio's announcement of the first patient dosed in the Phase 2 TRANQUILITY trial could have significant implications for the company's financial outlook. If successful, the trial could pave the way for Phase 3 studies, potentially positioning TOUR006 as a best-in-class treatment for ASCVD and other cardiovascular diseases. This would not only enhance the company's product portfolio but also likely increase its market valuation.
From an investor's perspective, the potential for quarterly dosing provides a competitive advantage, likely leading to better patient compliance and thereby higher market adoption. While the news is promising, it is essential to consider the high costs and risks associated with late-stage clinical trials. Investors should keep an eye on the company's cash flow, funding strategies and any partnerships or collaborations that could mitigate financial risk.
The cardiovascular drug market is highly competitive and constantly evolving. Tourmaline Bio's Phase 2 TRANQUILITY trial for TOUR006 could differentiate the company within this space, particularly if the drug demonstrates best-in-class potential. This trial focuses on reducing inflammation, a key driver of ASCVD, which affects millions globally.
Market interest will likely be high due to the dual focus on ASCVD and autoimmune disorders like thyroid eye disease. The potential for quarterly dosing is a unique selling point, addressing a common pain point in chronic disease management—frequent dosing schedules. However, market penetration will depend significantly on the trial's outcomes and subsequent Phase 3 results. If successful, this could position Tourmaline Bio to capture a substantial share of the cardiovascular and autoimmune treatment markets.
– First patient dosed in trial to evaluate the safety, pharmacokinetics and pharmacodynamics of TOUR006 in patients with inflammatory risk and chronic kidney disease –
– Topline data anticipated in the first half of 2025 with potential to advance TOUR006 toward Phase 3 readiness for atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases –
– TRANQUILITY trial intended to provide evidence of TOUR006’s best-in-class potential for ASCVD, including the potential for quarterly subcutaneous dosing –
NEW YORK, May 16, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced that the first patient has been dosed in its Phase 2 TRANQUILITY trial, marking the initiation of its clinical development program for TOUR006, a long-acting, fully human, anti-IL-6 monoclonal antibody, for the treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. TRANQUILITY is a randomized, double-blind, placebo-controlled trial enrolling patients with inflammatory risk, manifesting as elevated high-sensitivity C-reactive protein (hs-CRP) at baseline, and chronic kidney disease (CKD).
“New treatments are sorely needed for the millions of patients who remain at very high risk of heart attack, stroke, acute limb ischemia, and death despite traditional risk factor modification,” said Emil deGoma, MD, Senior Vice President of Medical Research at Tourmaline and former Medical Director of the Preventive Cardiovascular Program at the University of Pennsylvania. “Converging evidence from IL-6 human genetic studies, epidemiological studies, and mechanistic experiments as well as analyses from clinical trials of upstream IL-6 inhibition supports the therapeutic potential of IL-6 inhibition for patients across the spectrum of ASCVD as well as for patients with other cardiovascular diseases, including heart failure.”
The design of the TRANQUILITY clinical trial was informed by insights from six prior Phase 1 and Phase 2 studies of TOUR006. If successful, results from the Phase 2 TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready in 2025 for ASCVD and other cardiovascular diseases.
“TOUR006 is a true ‘pipelines in a product’ opportunity, seeking to address both serious cardiovascular diseases for which IL-6-driven inflammation plays a key role as well as serious autoimmune disorders, such as thyroid eye disease,” continued Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “We believe TRANQUILITY can showcase TOUR006’s potential as a best-in-class treatment in these indications, offering ease of use and enabling consistent patient adherence, thanks to a potential quarterly dosing schedule. We look forward to sharing topline results from TRANQUILITY in the first half of 2025.”
About the Phase 2 TRANQUILITY Trial
The Phase 2 TRANQUILITY trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), including CRP-lowering effect, of quarterly and monthly subcutaneous administration of TOUR006 in patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD). The selection of dosing regimens being evaluated in TRANQUILITY was informed by six previously completed Phase 1 and Phase 2 trials of TOUR006 in healthy volunteers and patients with rheumatoid arthritis, Crohn’s disease, or systemic lupus erythematosus as well as PK/PD modeling. For more information on the TRANQUILITY clinical trial, please visit clinicaltrials.gov (NCT06362759).
About TOUR006
TOUR006 is a long-acting, fully human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties, including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. TOUR006 has been previously studied in 448 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is developing TOUR006 in thyroid eye disease and atherosclerotic cardiovascular disease as its first two indications, with additional diseases under consideration.
About Tourmaline Bio
Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is TOUR006.
Cautionary Note Regarding Forward-Looking Statements:
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Tourmaline’s current beliefs and expectations. These forward-looking statements include, but are not limited to, expectations regarding the development and potential therapeutic benefits of TOUR006, including the belief of TOUR006 being a pipelines in a product opportunity, seeking to address both cardiovascular diseases and autoimmune disorders; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for TOUR006, and reporting of data therefrom, including the anticipation that topline data from the Phase 2 TRANQUILITY trial will be available in the first half of 2025, and the expectation that such data, if successful, will position Tourmaline to be Phase 3-ready in 2025 for ASCVD and other cardiovascular diseases; and patient population and market opportunities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline’s current or future product candidates, including the Phase 2 TRANQUILITY trial; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline’s current or future product candidates; the risk that Tourmaline’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) on May 13, 2024 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact
Scient PR
Sarah Mishek
SMishek@ScientPR.com
Investor Contact
Meru Advisors
Lee M. Stern
lstern@meruadvisors.com
FAQ
What is the focus of Tourmaline Bio's Phase 2 TRANQUILITY trial?
When is the topline data for the TRANQUILITY trial expected?
What is TOUR006, and what conditions does it target?
What is the potential benefit of TOUR006's dosing schedule?
How was the design of the TRANQUILITY trial informed?
