Laquinimod

The poster presentation, titled Safety, Tolerability and Distribution of Topical Laquinimod Eye Drops, an Innovative Immunomodulator Targeting Aryl Hydrocarbon Receptor: The LION Study, emphasizes, among other findings, that topical laquinimod was well tolerated with no toxicity or drug related adverse events at doses resulting in therapeutically relevant concentrations of laquinimod in the posterior parts of the eye. “These results support further investigation of laquinimod’s therapeutic potential in inflammatory eye diseases. There is unmet need for effective, steroid-sparing topical anti-inflammatory agents with favorable safety profiles that can reach the posterior segment”, said Dr. Dalia Mohammed El Feky, a Visiting Scholar at the Byers Eye Institute, Stanford University School of Medicine, Palo Alto, CA. The results from the LION study show that daily dose levels of either 0.6, 1.2 mg and 1.8 mg resulted in dose related intraocular concentrations of laquinimod, which reached a therapeutically relevant level in both the vitreous humor and anterior chamber. Patients scheduled to undergo pars plana vitrectomy for various indications were administered laquinimod daily as eye drops during a 14-day preoperative period. Laquinimod administered as eye drops at the chosen daily dose levels was safe and well tolerated for the period of administration studied, and no dose-limiting toxicities were reported in any of the subjects. “Laquinimod, has a distinct immunomodulatory mechanism compared to conventional immunosuppressants. Its effects go beyond simple suppression, as it promotes a durable shift from an autoimmune-prone landscape to a self-tolerant, balanced state and enhances neuronal protection and repair mechanisms in addition to its anti-inflammatory properties. Given these unique immunological and neuroprotective effects along with its ability to reach the posterior segment, laquinimod holds a significant promise for investigation in patients with uveitis as well as patients with macular edema secondary to inflammation (MESI)” said Quan Đông Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine and Pediatrics at the Byers Eye Institute and the Stanford University School of Medicine (Palo Alto, USA) and Principal Investigator of the LION Study. Previously this year, on June 27, the top-line results from the LION study were discussed by Dr. El Feky as an oral presentation at the 2025 International Ocular Inflammation Society (IOIS) Congress, the largest scientific meeting in the field of uveitis and ocular inflammation in the world, in Rio de Janeiro, Brazil. Active Biotech’s focus for the laquinimod program is now directed towards identifying the best development partner for the continued clinical development of laquinimod in eye disorders. The abstract is available online on https://aao.apprisor.org/apsSession.cfm?id=PO718

SECOND QUARTER IN BRIEF Active Biotech reported positive top-line results from the LION study on ocular absorption and distribution of laquinimod in the eye (May 5) Active Biotech announced that a patent for tasquinimod in myelofibrosis was granted in Europe (May 21) Active Biotech reported study results with tasquinimod in heavily pre-treated patients with relapsed refractory multiple myeloma (May 23) Active Biotech announced that results from tasquinimod study in heavily pretreated patients with relapsed refractory multiple myeloma was presented at ASCO 2025 and that the results were available on Active Biotech’s website (June 9) Active Biotech published an interview with investigators of laquinimod eye drop study LION on the website (June 30) EVENTS AFTER THE END OF THE PERIOD Active Biotech provided status update of its development programs (July 8) FINANCIAL SUMMARY The report is also available at www.activebiotech.com