Press release

European Patent Office has granted Active Biotech’s patent application for eye drop formulation of laquinimod

Lund, October 23 2024 – Active Biotech (NASDAQ STOCKHOLM: ACTI) today announced that the European Patent Office (EPO) has granted Active Biotech’s patent application covering a proprietary developed eye drop formulation of laquinimod.

The patent “Laquinimod formulation for ocular use”, published on October 23, 2024 under European patent number 4312986, provides protection and market exclusivity until 2042.

“The now granted patent is important for the continued development of laquinimod in eye diseases. The eye drop formulation of laquinimod has been documented to be safe in healthy subjects and initial results from patients undergoing eye surgery show that laquinimod is distributed to the posterior parts of the eye, which makes us very enthusiastic for the continued clinical development”, says Helén Tuvesson, CEO

An innovative formulation of laquinimod for corneal application was developed and optimised to facilitate trans-corneal-scleral passage of laquinimod for use in the treatment of inflammatory eye disorders.

The eye drop formulation has been tested in a phase I study and documented to be safe without any serious adverse effects in healthy subjects treated for up to 21 days. We also recently reported initial data from an ongoing phase I biodistribution study in patients undergoing eye-surgery at Byers Eye Institute, Stanford University in US, which demonstrate that use of laquinimod eye-drops leads to therapeutically relevant intra-ocular concentrations. This study is recruiting towards completion in 2024, and activities are now being increased to find a partner for the planned clinical phase II/III development of laquinimod in inflammatory eye disorders.

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 has been initiated. Also ongoing is a clinical Phase Ib/IIa study in multiple myeloma. Laquinimod is in clinical development for the treatment of non-infectious uveitis. A clinical phase I program with a topical ophthalmic formulation is ongoing 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.