Press release

Interview with investigators of laquinimod eye drop study LION now available on Active Biotech’s website

Lund, Sweden, June 30, 2025 – Active Biotech (NASDAQ STOCKHOLM: ACTI) announced today that an interview with the investigators of the clinical ocular biodistribution LION study at the International Ocular Inflammation Society (IOIS) meeting, on June 25-28 in Rio de Janeiro, Brazil, is available on the company’s website. The interview highlights the background of and the results from the LION study with laquinimod eye drops.

“The potential of this type of treatment is vast. There is definitively an unmet need for effective, local delivery of therapeutic agents. Here we have a big advantage, we know that already at 1-3 times per day you see a very nice dose-dependent type of availability of laquinimod in the posterior parts of the eye. The next step would be to show therapeutic efficacy in patients,” said Principal Investigator and Professor of ophthalmology, Dr. Quan Dong Nguyen.

The interview with Principal Investigator and Professor of ophthalmology, Dr. Quan Dong Nguyen, and co-Investigator Dr. El Feky from the Byers Eye Institute, Stanford University School of Medicine, Palo Alto, CA, was conducted after a presentation by Dr. El Feky on June 27, and is available here. In the recorded interview, Active Biotech’s Chief Medical Officer Dr. Erik Vahtola also presents the background of laquinimod and details regarding the study design, patient population and study results. Dr. El Feky’s presentation is available here.

The results provide a strong rationale to initiate a phase II/III clinical program in patients with uveitis where there is a high unmet medical need for a non-steroidal treatment option. 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. Active Biotech has previously communicated the positive topline results from the LION study.

About Active Biotech

Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that develops first-in-class immunomodulatory treatments for oncology and immunology indications with a high unmet medical need and significant commercial potential. Active Biotech currently holds three projects in its portfolio, of which tasquinimod and laquinimod are wholly owned small molecule immunomodulators with a mode of action that includes modulation of myeloid immune cell function. The projects are in clinical development for hematological malignancies and inflammatory eye disorders, respectively. The company's core focus is on the development of tasquinimod in myelofibrosis, a rare blood cancer, where clinical proof-of-concept studies have been initiated. A clinical Phase Ib/IIa study in multiple myeloma is being concluded. Laquinimod is in clinical development for the treatment of non-infectious uveitis. A clinical phase I program with a topical ophthalmic formulation has been performed to support phase II development together with a partner. The third pipeline project is naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, which is in a phase Ib/II clinical program in patients with advanced solid tumors. Please visit www.activebiotech.com for more information.

About laquinimod

Laquinimod is a first-in-class immunomodulator that promotes immune tolerance and reduces the pro-inflammatory and angiogenic response by targeting of the myeloid cell compartment. Laquinimod is developed as a new treatment for inflammatory eye disorders in the first step non-infectious uveitis. Laquinimod was previously studied in patients with neurodegenerative and inflammatory diseases, including a phase III randomized study program in multiple sclerosis (MS) patients. The clinical safety and tolerability of laquinimod is well known and preclinical data in disease models support the use of laquinimod for the treatment of severe eye disorders including uveitis and eye disorders with abnormal vascularization.
For more information about the study please see clinicaltrials.gov NCT06161415.

About the LION study

A proprietary formulation of laquinimod for corneal application was developed, taking the specific physico-chemical characteristics of this agent into account, to facilitate that a clinically relevant intraocular therapeutic concentration of laquinimod can be obtained.
The study (NCT06161415) which was conducted by principal investigator Professor Dr Nguyen at the Byers Eye Institute, Stanford University, Palo Alto, CA, US, aimed to evaluate safety and tolerability and ocular biodistribution of laquinimod when administered as escalating doses of eye drops (stage 1) and a randomized, controlled comparison of two doses (stage 2) in subjects undergoing elective vitrectomy. It was decided to close the study after stage 1 based on the positive safety, tolerability and biodistribution results.