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Tarsus Doses First Participant in Calliope, A Phase 2 Clinical Trial of TP-05 (lotilaner), a Novel Investigational Oral Tablet for the Potential Prevention of Lyme Disease
Globenewswire· 2026-03-31 12:30
Core Insights - Tarsus Pharmaceuticals has initiated a Phase 2 clinical trial (Calliope) for TP-05 (lotilaner), an investigational oral therapy aimed at preventing Lyme disease by killing infected ticks before disease transmission occurs [1][2][3] Company Overview - Tarsus Pharmaceuticals focuses on innovative treatments across various therapeutic areas, including eye care, dermatology, and infectious disease prevention [7][8] - The company is advancing its pipeline with TP-05 for Lyme disease prevention and TP-04 for ocular rosacea, both currently in Phase 2 trials [8] Clinical Trial Details - The Calliope trial is a randomized, double-blind, placebo-controlled study involving approximately 700 healthy adults at risk for Lyme disease, with enrollment expected to complete during the 2026 tick season and topline results anticipated in the first half of 2027 [2][3] - The trial design is based on previous successful studies, including a Phase 2a proof-of-concept study that demonstrated over 90% tick mortality within 24 hours of TP-05 administration [4] Lyme Disease Context - Lyme disease is the most common vector-borne disease in the U.S., with over 35 million Americans at moderate to high risk and approximately 300,000 to 400,000 diagnosed annually [3][6] - There are currently no FDA-approved pharmacological prophylactic options for Lyme disease, highlighting the need for innovative preventive measures [3][6] Scientific and Public Health Implications - The shift from treating Lyme disease post-infection to a preventive approach could significantly impact public health, especially as climate change expands the geographic range of ticks [3][6] - New prophylactic options like TP-05 could address the increasing burden of tick-borne illnesses and reduce the risk of serious long-term complications associated with Lyme disease [3][6]
Tarsus to Report Third Quarter 2025 Financial Results on Tuesday, November 4, 2025
Globenewswire· 2025-10-28 21:00
Core Viewpoint - Tarsus Pharmaceuticals, Inc. is set to report its third quarter 2025 financial results and provide a corporate update through a live webcast on November 4, 2025 [1] Company Overview - Tarsus Pharmaceuticals, Inc. focuses on revolutionizing treatment for patients, particularly in eye care, by applying proven science and new technology [2] - The company is advancing its pipeline to address diseases with high unmet needs across various therapeutic categories, including eye care and infectious disease prevention [2] - XDEMVY® (lotilaner ophthalmic solution) 0.25% is FDA approved for treating Demodex blepharitis in the United States [2] - Tarsus is developing TP-04 as an ophthalmic gel for potential treatment of Ocular Rosacea and TP-05 as an oral tablet for potential prevention of Lyme disease, both currently in Phase 2 [2]
Tarsus to Report Second Quarter 2025 Financial Results on Wednesday, August 6, 2025
Globenewswire· 2025-07-30 21:00
Company Overview - Tarsus Pharmaceuticals, Inc. focuses on revolutionizing treatment for patients, particularly in eye care, by applying proven science and new technology [2] - The company is advancing its pipeline to address diseases with high unmet needs across various therapeutic categories, including eye care and infectious disease prevention [2] Product Development - Tarsus has FDA approval for XDEMVY® (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis [2] - The company is developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease [2] Upcoming Events - Tarsus Pharmaceuticals will host a live webcast on August 6, 2025, at 1:30 p.m. PT / 4:30 p.m. ET to report its second quarter 2025 financial results and provide a corporate update [1]
Elanco Sells Royalty and Milestone Rights for Lotilaner in Human Health to Blackstone; Accelerates Debt Paydown
Prnewswire· 2025-05-05 10:27
Core Insights - Elanco Animal Health announced the sale of future tiered royalties and commercial milestones related to XDEMVY for $295 million in cash, aimed at accelerating debt reduction and achieving a net leverage ratio of 3.9x to 4.3x adjusted EBITDA by the end of 2025 [1][3] - The transaction is expected to reduce interest expenses by approximately $10 million, offset by the sale of about $10 million in royalties based on Elanco's initial 2025 guidance [1] Company Overview - Elanco Animal Health is a global leader in animal health, dedicated to innovating and delivering products and services to prevent and treat diseases in farm animals and pets, with a 70-year heritage in the industry [7] - The company is focused on high-impact innovation and aims to enhance its core business sales growth in 2025 [3] Product Development - Lotilaner was exclusively licensed to Tarsus Pharmaceuticals in 2019 for human health applications, and in 2023, XDEMVY became the first lotilaner-based product approved for human use, specifically for treating Demodex blepharitis [2] - Elanco retains rights to all royalty payments on net sales outside the U.S. and any future human applications of lotilaner beyond ophthalmic solutions [4] Strategic Partnerships - The collaboration with Blackstone Life Sciences and Blackstone Credit & Insurance is recognized as a significant investment to support Elanco's goals and the potential impact of XDEMVY on patients [3][9]
Elanco Sells Royalty and Milestone Rights for Lotilaner in Human Health to Blackstone; Accelerates Debt Paydown
Prnewswire· 2025-05-05 10:27
Core Insights - Elanco Animal Health announced the sale of future tiered royalties and commercial milestones related to XDEMVY for $295 million in cash, aimed at accelerating debt reduction and achieving a net leverage ratio of 3.9x to 4.3x adjusted EBITDA by the end of 2025 [1][3] - The agreement includes royalties from U.S. net sales of XDEMVY from April 2025 through August 2033, while Elanco retains rights to royalties from sales outside the U.S. and future human applications of lotilaner beyond ophthalmic solutions [4] Company Overview - Elanco is a global leader in animal health, dedicated to innovating products and services for disease prevention and treatment in farm animals and pets, with a 70-year heritage in the industry [7] - The company is focused on high-impact innovation and aims to enhance core business sales growth in 2025, leveraging the cash from the royalty sale to support its deleveraging goals [3] Product Development - Lotilaner was exclusively licensed to Tarsus Pharmaceuticals in 2019 for human health applications, and in 2023, XDEMVY became the first lotilaner-based product approved for human use, specifically for treating Demodex blepharitis [2][4] - The collaboration between Elanco and Tarsus has led to the rapid adoption and commercial success of XDEMVY, addressing a significant health need for patients suffering from a common eyelid disease [3]
Tarsus to Report First Quarter 2025 Financial Results on Thursday, May 1, 2025
GlobeNewswire News Room· 2025-04-24 21:00
Company Overview - Tarsus Pharmaceuticals, Inc. focuses on revolutionizing treatment for patients, particularly in eye care, by applying proven science and new technology [2] - The company is advancing its pipeline to address diseases with high unmet needs across various therapeutic categories, including eye care and infectious disease prevention [2] Product Development - Tarsus has FDA approval for XDEMVY® (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis [2] - The company is developing TP-04 for the potential treatment of Ocular Rosacea and TP-05 as an oral tablet for the potential prevention of Lyme disease [2] Upcoming Events - Tarsus Pharmaceuticals will host a live webcast on May 1, 2025, at 1:30 p.m. PT / 4:30 p.m. ET to report its first quarter 2025 financial results and provide a corporate update [1]