US-based clinical stage biotherapeutics company Noveome has begun its Phase II clinical trial of ST266 to treat allergic conjunctivitis.
ST266 is a secretome, otherwise known as a rich, complex solution of molecules released from proprietary cells. The ST266 secretome contains many biologically active molecules present in physiological concentrations.
As a mixture of biomolecules, this secretome is important during biologic processes that are available at sufficiently low levels to avoid negative effects.
The Phase II multi-centre, double-blind, randomised, placebo-controlled study is being conducted to test the efficacy, safety and tolerability of ST266 ophthalmic drops to treat the signs and symptoms of allergic conjunctivitis.
The trial will be conducted based on Ora’s Conjunctival Allergen Challenge (Ora-CAC) Model, approved by the US Food and Drug Administration (FDA) as the standard methodology for evaluation of the efficacy of products for allergic conjunctivitis.
Allergic conjunctivitis is a commonly occurring allergic condition caused by exposure to an allergen such as dust, pollen and mould, which cause mast cell degranulation and the release of histamine.
It leads to symptoms such as ocular itching and redness, chemosis and blepharitis.
A late phase reaction triggered by the ailment occurs when mast cells synthesise and release a variety of pro-inflammatory mediators, which increase vascular permeability and necessitate treatment with steroids.
The study is primarily focused on measuring ocular itching and conjunctival redness over time, following an allergen challenge.
Noveome chief medical officer Kenneth Mandell said: “There is a need to develop new treatment options that are better tolerated and more effective than conventional allergy therapies.
“By restoring paracrine signalling between cells to help reduce inflammation, ST266 holds promise as a new approach to treating allergic conjunctivitis and other forms of ocular inflammation.”
