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Safety and ocular biodistribution support development of laquinimod eye drops for inflammatory eye disorders

Lund, May 30 2023 – Active Biotech (NASDAQ Stockholm:ACTI) announces today that data from the recently completed phase I study with the eye drop formulation of laquinimod, a small molecule immunomodulator in development for ocular inflammation, will be presented in a poster session at the International Ocular Inflammation Society (IOIS) 2023 Meeting in Berlin, 6-9 September, 2023. The poster presents results of safety and tolerability in the phase I randomized, placebo-controlled, double-masked, subsequent-group study with laquinimod eye drops in healthy subjects. Furthermore, the intraocular biodistribution of laquinimod eye drops in the rabbit will be presented.

The clinical study (NCT05187403) which was conducted at the Medical University of Vienna, Department of Clinical Pharmacology, included 54 healthy subjects who received single doses (0.23mg – 1.2mg) or multiple doses (0.3mg – 0.6mg for 14 or 21 days) of laquinimod eye drops in one eye and placebo in the other eye. Laquinimod was demonstrated to be safe and tolerable; no serious adverse events were reported, and ocular assessments did not reveal any tolerability concerns.

In the biodistribution study in rabbit, laquinimod was detected in the cornea and retina/choroid of the rabbit eye following administration of laquinimod eye drops.

The abstract is available online at IOIS web page.

Details on the presentation:

  • Abstract Title: Topical ocular laquinimod in development for inflammatory eye disorders
  • Poster Nr / ID: 144
  • Poster Session: 1 - P 101-164
  • Presentation Date: Thursday September 7, 2023

For further information, please contact:

Helén Tuvesson, CEO, +46 46 19 21 56, helen.tuvesson@activebiotech.com
Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com

About Active Biotech

Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: The wholly owned small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is in a clinical phase I study with a topical ophthalmic formulation, to be followed by phase II-study for treatment of non-infectious uveitis. Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, 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.

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Safety and ocular biodistribution support development of laquinimod eye drops for inflammatory eye disorders

Datum 2023-05-30, kl 11:30
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Safety and ocular biodistribution support development of laquinimod eye drops for inflammatory eye disorders
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