NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has approved Klisyri® (tirbanibulin), a first-in-class topical microtubule inhibitor developed by Almirall (Athenex), for the treatment of actinic keratosis (AK) of the face or scalp. The approval marks a significant advancement in dermatologic care, offering a short, 5-day treatment course with proven efficacy and minimal adverse events. Rachel Hastings, Managing Partner at DelRicht Research, applauded the leadership of Dr. Sarah Jackson in the pivotal trial.

Dr. Sarah Jackson, Principal Investigator at Audubon Dermatology in New Orleans, played a key role in the clinical trials that supported FDA approval through her continued partnership with DelRicht Research. With multiple studies conducted since 2016, Dr. Jackson’s leadership has helped bring innovative skin health therapies to patients across the Gulf South.

Rachel Hastings on A New Era for AK Treatment

Actinic keratosis is a chronic, precancerous skin condition caused by long-term sun exposure and affects as many as 1 in 4 adults. If left untreated, it can progress into squamous cell carcinoma. Klisyri® delivers a convenient, once-daily topical treatment over 5 days, the shortest regimen available to date for AK, with a favorable safety profile and no study withdrawals due to adverse events.

“Shorter treatment durations mean better adherence and less disruption to patients’ daily lives,” said Rachel Hastings, Managing Partner at DelRicht Research. “We’re incredibly proud of Dr. Jackson’s involvement in helping bring this breakthrough option to patients who need it.”

“Shorter treatment durations mean better adherence and less disruption to patients’ daily lives. We’re incredibly proud of Dr. Jackson’s involvement in helping bring this breakthrough option to patients who need it.”

— Rachel Hastings, Managing Partner at DelRicht Research

Robust Clinical Results Across a Large U.S. Study Population

The FDA’s decision was supported by data from two pivotal Phase III trials involving 702 patients across 62 U.S. sites. Patients treated with Klisyri® achieved significantly higher rates of complete clearance of AK lesions compared to placebo (44% and 54% in the two studies, respectively), with a strong tolerability profile.

“Being part of this trial gave our dermatology team the opportunity to offer cutting-edge care to patients right here in New Orleans,” said Dr. Jackson. “It’s exciting to now see Klisyri available as a safe and practical treatment option that fits into real-world routines.”

“Being part of this trial gave our dermatology team the opportunity to offer cutting-edge care to patients right here in New Orleans. It’s exciting to now see Klisyri available as a safe and practical treatment option that fits into real-world routines.”

— Dr. Sarah Jackson, Principal Investigator at DelRicht Research

Expanding Patient Access Through Clinical Research

With the approval and upcoming U.S. launch of Klisyri®, patients will soon have access to a simplified and effective treatment for one of the most common dermatologic conditions. The work of engaged investigators like Dr. Jackson ensures that novel therapies make their way from clinical trials to community practices.

DelRicht Research is honored to have supported this milestone through site-level execution that brings next-generation therapies to the patients who need them most.

Read the full press release from Almirall (Athenex).