What inspired you to found Tarsus, and what is the company's one-of-a-kind contribution to the life sciences sector?
My co-founding partner, Michael Ackermann, PhD, and I really wanted to take an unmet-need driven approach to innovation. We also both recognized eyecare as a critical space because vision is our most valued sense - and while many diseases of the eye have been served already, eyelid diseases are still an open and new frontier. That’s where the name Tarsus comes from, it means the eyelid, and we are focused on serving patients with eyelid diseases. We started with a highly prevalent eyelid disease that impacts ~25 million eye care patients in the U.S. called Demodex blepharitis. This disease is caused by an infestation of the Demodex mite, the most common ectoparasite found on humans. We saw a significant opportunity in this disease as there are no current FDA approved treatments, and there is a large unmet patient need. After a very thorough process, we identified lotilaner, a best-in-class antiparasitic that actually evolved from Eli Lilly's animal health division and reformulated it for human use. We are now on the path to developing the first novel drug for Demodex blepharitis.
You recently made an important announcement regarding your candidate, TP-03. How far have you progressed?
From the start, we knew there was a significant patient need (and eye care provider demand) for a treatment for Demodex blepharitis, so our goal was to move as quickly as possible. We licensed the drug in 2019 and we have a PDUFA target action date of August 25, 2023. Over this time period, we’ve evaluated TP-03 in two pivotal trials involving more than 800 patients. These trials have shown that TP-03 results in a complete resolution of Demodex blepharitis, which is highly encouraging. Pending FDA approval, we are excited to commercialize the drug later this year because there is a significant unmet need, a strong data set, and highly motivated patients who want to improve their ocular health.
Can this breakthrough be applied to other diseases? What else do you have in your pipeline?
We have a diverse pipeline, connected by two important elements: first, we want to address and prevent diseases that really have no solution today and second, diseases that have a parasitic target. The goal is to take the lotilaner molecule and apply it to other parasitic diseases that we think go unserved.
For example, we are conducting Phase 2a trial, studying TP-03 for the treatment of Meibomian Gland Disease (MGD), another very common eyelid disease that occurs when the glands do not produce enough lipids, or the lipids are of poor quality. Approximately 2/3 of the estimated 34 million Dry Eye patients in the U.S. also suffer from MGD. Demodex mites are thought to be key drivers in the disease process. In parallel, we have initiated a Lyme disease prevention program, which we are extremely excited about. We realized that lotilaner in an oral tablet form could offer an intuitive and powerful preventative option for this disease. It is important to note that there is currently no FDA-approved pharmacological option for preventing Lyme disease; our TP-05 oral tablet, a systemic formulation of lotilaner, has great potential. We are also currently in a Phase 2a trial for TP-05. Finally, we have a topical gel that’s in development, TP-04, to potentially treat papulopustular rosacea, which is also connected to Demodex mites on the skin.
Your peers have observed that financial markets have been relatively harsh on life sciences over the past year. What has been your strategy to fund your efforts?
For us, it is not just about the amount of money we raise, but also about who we bring on as an investor, who is best suited for the next leg of our journey and beyond. We aim to attract investors that see our developments as novel drugs that offer profound impact and complete resolution for patients, and can imagine Tarsus as one of those companies that goes from a small company to commercial success in a short timeframe.
What are the next milestones you have in sight?
Our three main objectives are to successfully launch TP-03 for Demodex blepharitis, accelerate our pipeline to potentially get more novel treatments to patients as quickly as possible, and to transform our company into a leading eye care organization.
Our biggest commitment is to the patients.
If and when TP-03 receives FDA approval, we will focus our efforts on ensuring the drug is affordable and easy to access. The first step in this process is to educate eye care providers on how to diagnose and screen for this disease. Equally important is our ongoing discussions with payors. We are working very hard on raising awareness of the disease and the potential benefits of our therapy to key stakeholders who will ultimately help diagnose and provide access to patients. We are also committed to educating consumers about this disease's visual symptoms, which can significantly help people recognize it, and encourage them to seek treatment.
Finally, we want to transform the company, with the goal of having multiple products on the market in the next three to five years, and a more diverse pipeline where we have drugs beyond lotilaner. Tarsus is taking an unconventional approach and we want our drugs to reach patients as quickly and efficiently as possible.
