Tarsus Announces Positive Topline Results from Carpo, a Phase 2a Proof-of-Concept “Tick-Kill” Trial Evaluating TP-05 (lotilaner) for the Prevention of Lyme Disease
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Insights
The findings from the Phase 2a Carpo trial for TP-05 indicate a substantial leap in the prophylactic treatment of Lyme disease. The trial's double-blind, placebo-controlled design underscores the reliability of the data. A noteworthy point is the high tick mortality rate observed, which is significantly higher than the placebo group, implying TP-05's efficacy. Given that Lyme disease requires the tick to be attached for an extended period to transmit the disease, the rapid tick mortality caused by TP-05 could indeed be a game-changer in preventing transmission.
The potential market impact of TP-05 is significant, considering the estimated annual cost of Lyme disease treatment in the U.S. healthcare system. If TP-05 progresses through further clinical trials successfully and gains FDA approval, it could reduce the economic burden of Lyme disease treatment and potentially disrupt the market for current prophylactic measures.
From an economic standpoint, the successful development of TP-05 could have a positive impact on the healthcare system by reducing the long-term costs associated with Lyme disease, which include not only direct medical expenses but also indirect costs such as lost productivity. The reduction in disease incidence could lead to significant savings for insurers and public health entities. Furthermore, the novel oral delivery of TP-05 may offer advantages over existing prevention methods, such as vaccines, in terms of ease of administration and patient compliance, potentially leading to wider adoption and further economic benefits.
Analyzing the pharmaceutical market, the introduction of TP-05 could create a new niche for oral tick prophylaxis. Currently, the market for Lyme disease prevention is limited to personal protective measures and vaccines, which have their own limitations. TP-05's unique selling proposition is its 'on-demand' use, as opposed to a vaccine's long-term immunity, which may not be suitable for everyone. If TP-05's subsequent trials confirm its efficacy and safety, Tarsus Pharmaceuticals could capture a significant share of the market, potentially affecting the stock's valuation positively. The company's strategic focus on unmet needs and the application of new technology could position it favorably within the biotech sector, attracting investor interest.
TP-05 demonstrated tolerability and statistically significant tick mortality, suggesting potential for on-demand Lyme disease prophylaxis
IRVINE, Calif., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, today announced positive topline results from the Phase 2a Carpo trial evaluating TP-05 (lotilaner), a novel, investigational oral therapeutic for the prevention of Lyme disease.
In this randomized, double-blind, placebo-controlled trial, the ability of TP-05 to kill ticks attached to subjects with a single treatment of TP-05 (low or high dose) was evaluated compared to placebo. Sterile, non-pathogenic nymphal ticks were placed on the skin of healthy human volunteers at two separate instances (one day prior to dosing and on Day 30 after dosing). Tick mortality was evaluated within 24 hours of attachment after each placement. In most cases, ticks must be attached for 36-48 hours or more before Lyme disease can be transmitted, so killing ticks within 24 hours of attachment can greatly increase the probability of disease prevention 1.
Both the high and low doses of TP-05 demonstrated a statistically significant benefit in killing ticks compared to placebo. Specifically, after the Day 1 tick challenge, mean tick mortality was
Similarly, at the 30-day challenge, mean tick mortality at 24 hours after placement was
“Lyme disease remains a growing public health concern associated with long-term consequences for millions of patients and an estimated
“The risk of infection from tick-borne diseases, such as Lyme disease and other serious infections, is growing at an alarming rate, and the consequences can be debilitating and long-lasting,” said Linden Hu, M.D., the Paul and Elaine Chervinsky Professor in Immunology at Tufts University School of Medicine and Principal Investigator for the Carpo trial. “The tick-kill rates seen at Day 1 and Day 30 suggest that TP-05 may have the potential to provide both rapid and durable protection against multiple tick-borne diseases, which would be a welcome alternative to vaccines in the prevention armamentarium.”
About TP-05
TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. TP-05 is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks to potentially prevent Lyme disease transmission.
About Lyme Disease
Lyme disease is the most common vector-borne disease in the United States, transmitted to humans by Borrelia burgdorferi infection following the bite of a tick vector. Over 30 million Americans are considered to be at high or moderate risk of contracting Lyme disease, and there are approximately 300,000 – 400,000 cases in the U.S. each year. Lyme disease can potentially cause severe, often debilitating symptoms with permanent and irreversible damage. The disease can result in inflammation, nerve, joint and muscle pain and swelling, numbness, shortness of breath and – in severe cases – neurological complications such as facial palsy, vision issues and meningitis, including severe headaches and neck stiffness, as well as cardiac complications. Lyme disease can often go undetected and untreated because the ticks are not always noticed before they transmit the disease. People who spend extended amounts of time outdoors in wooded, grassy areas are at higher risk of Lyme disease. Data from the Centers for Disease Control and Prevention (CDC) show that the risk of Lyme disease is spreading to new geographical areas, resulting in a significant need for prophylactic solutions. Currently, there are no FDA-approved pharmacological prophylactic options for Lyme disease.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology and infectious disease prevention. XDEMVY® (lotilaner ophthalmic solution)
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” These statements include statements regarding the potential market size for TP-05 with respect to Lyme disease prevention, anticipated benefits of its product candidates including TP-05 and its potential applicability to Lyme disease prevention, as well as that of a variety of tick-borne diseases, the timing, objectives, and results of the clinical trials including the complete clinical results of the Carpo trial, anticipated regulatory and development milestones, our ability to continue investing in our business, and the quotations of Tarsus’ management and consultants. The words, without limitation, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Further, there are other risks and uncertainties that could cause actual results to differ from those set forth in the forward-looking statement and they are detailed from time to time in the reports Tarsus files with the Securities and Exchange Commission, including Tarsus’ Form 10-K for the year ended December 31, 2022 filed on March 17, 2023, the Form 10-Q for the quarter ended September 30, 2023 filed on November 9, 2023 with the SEC, which Tarsus incorporates by reference into this press release, copies of which are posted on its website and are available from Tarsus without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Any forward-looking statements contained in this press release are based on the current expectations of Tarsus’ management team and speak only as of the date hereof, and Tarsus specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Reference:
1 Centers for Disease Control and Prevention, Lyme Disease Transmission.
| Media Contact: | |
| Adrienne Kemp | |
| Sr. Director, Corporate Communications | |
| (949) 922-0801 | |
| akemp@tarsusrx.com | |
| Investor Contact: | |
| David Nakasone | |
| Head of Investor Relations | |
| (949) 620-3223 | |
| DNakasone@tarsusrx.com |
FAQ
What is the purpose of the Phase 2a Carpo trial for Tarsus Pharmaceuticals (NASDAQ: TARS)?
What were the results of the trial comparing TP-05 to placebo in terms of tick mortality?
Who is Bobby Azamian, M.D., Ph.D., in relation to Tarsus Pharmaceuticals (NASDAQ: TARS)?
What do the results of the trial suggest about TP-05's potential for tick-borne disease protection?
What was the underlying goal of Tarsus Pharmaceuticals (NASDAQ: TARS) in developing TP-05 for Lyme disease prevention?
