Noveome Biotherapeutics, Inc., a clinical-stage company and leader in the field of paracrine signaling, today announced the initiation of a Phase 2 clinical trial of ST266, the company’s novel secretome, to treat patients with allergic conjunctivitis, an ocular inflammation condition caused by exposure to an allergen. ST266, the company's lead product, harnesses the power of paracrine signaling and has been found to help promote cellular homeostasis, modulate inflammation and regenerate damaged cells. Paracrine signaling is the dynamic communication between nearby cells to induce a coordinated change in cell behavior.
“Allergic conjunctivitis continues to be one of the most common disorders for patients with allergies in the U.S. and across the globe. There is a need to develop new treatment options that are better tolerated and more effective than conventional allergy therapies,” said Kenneth J. Mandell, M.D., Ph.D., Chief Medical Officer of Noveome. “By restoring paracrine signaling between cells to help reduce inflammation, ST266 holds promise as a new approach to treating allergic conjunctivitis and other forms of ocular inflammation.”
The Phase 2 multi-center, double-blind, randomized, placebo-controlled trial will assess the efficacy, safety and tolerability of ST266 ophthalmic drops for the treatment of the signs and symptoms of allergic conjunctivitis. The trial will be conducted using Ora, Inc.’s Conjunctival Allergen Challenge (Ora-CAC®) Model, which is accepted by the U.S. Food and Drug Administration (FDA) as the standard methodology for evaluation of the efficacy of products for allergic conjunctivitis. The primary endpoint of the study will measure ocular itching and conjunctival redness over time following an allergen challenge. For additional information on this clinical trial, please visit www.clinicaltrials.gov, Identifier NCT02978183.
“Based on previous clinical safety data for ST266 in ophthalmology and positive data in validated preclinical models of ocular inflammation and allergy, the initiation of our second Phase 2 clinical trial is a logical and important step in Noveome’s development as we advance our ophthalmology program forward,” said A. Clarke Atwell, Chief Executive Officer and President of Noveome. “We remain committed to our greater goal of unlocking the potential of paracrine signaling to treat a wide variety of medical conditions.”
Earlier this year, Noveome announced positive top-line data from Phase 1 trials of ST266 for the treatment of ocular and oral health conditions. All studies showed that ST266 was well tolerated and no drug-related adverse events were reported.
Allergic conjunctivitis is one of the most common allergic conditions in the world with 22 million patients seeking treatment options in the U.S. alone. The condition is caused by exposure to an allergen like dust, pollen and mold which causes mast cell degranulation and the release of histamine. Early phase reaction symptoms typically occur within minutes of exposure to an allergen and include ocular itching and redness, chemosis and blepharitis. A late phase reaction occurs when mast cells synthesize and release a variety of pro-inflammatory mediators, which increase vascular permeability and requires treatment with steroids.
ST266 is a novel secretome – a rich, complex solution of molecules secreted from proprietary cells. Instead of a single drug and target, the ST266 secretome contains many biologically active molecules, present in physiological concentrations. This secretome is a mixture of biomolecules necessary at critical points in biologic processes that are available at sufficiently low levels to avoid negative effects. In multiple preclinical studies, ST266 has demonstrated the following unique attributes, which can be applied across a wide range of disease indications to improve patient outcomes: modulates inflammation, speeds impaired wound healing, promotes bone restoration, restores nerve function and regenerates cells. In addition, Phase I trials have demonstrated the robust safety of ST266 when administered as ophthalmic, dermal, and oral formulations.
Noveome is a Pittsburgh, PA-based, clinical stage biotherapeutics company leveraging the science of paracrine signaling to restore cellular communication in impaired tissue and disease processes. Our paracrine therapeutic approach has the potential to create safe and effective products across a wide range of disease indications to improve patient outcomes. For more information on Noveome visit www.noveome.com.
Noveome Biotherapeutics, Inc.
A. Clarke Atwell, 412-402-9914
Chief Executive Officer & President
Media MacDougall Biomedical Communications
Joe Rayne, 781-235-3060