OrPro’s Cystic Fibrosis Treatment Theradux Receives US Patent

OrPro’s Cystic Fibrosis Treatment Theradux Receives US Patent

OrPro Therapeutics, Inc. a company developing Theradux (ORP-100), a new inhaled treatment designed to treat cystic fibrosis (CF) and other obstructive diseases characterized by thickened, stiff and adhesive mucus, recently announced that the U.S. Patent and Trademark Office (USPTO) has issued patent No. 9,168,290 covering the drug’s capacity to improve the viscoelastic properties of mucus secretions.

In patients with cystic fibrosis, mucus is incapable of performing its fundamental function of lung clearance, which leads to complicated inflammation and chronic infection.

Theradux is a non-systemic form of the enzyme thioredoxin, which plays a vital role in preventing the formation of excess molecular bonds within the mucus layer. In patients with cystic fibrosis, this impaired activity leads to progressive lung function impairment. The Theradux nebulized treatment works by relaxing abnormally stiffened mucus, and was developed with the aim of restoring the mucus transport and lung clearance in the majority of CF patients.

The drug was designed to be effective as a monotherapy or in combination with approved and in-development CF Transmembrane Regulator (CFTR) modifier medications in order to slow the progression to lung failure. CFTR modifier medications represent a major revolution in CF treatment because these agents target the basic defect as opposed to targeting the effects of the disease.

These new, broad claims are the first in a new United States and international patent portfolio owned by OrPro that outspreads patent coverage to nearly 2034 and complements the company’s present in-licensed patent estate surrounding thioredoxin’s capacity to alter mucus viscoelasticity. The company is the exclusive proprietor of issued and pending thioredoxin-related patents from its collaborator National Jewish Health.

“The wide scope of this patent reflects the novelty of our research findings and their importance in creating new treatment options for patients in need,” said Peter B. Heifetz, Ph.D., president and CEO of OrPro, in a press release.

OrPro recently presented results from in-vivo and in-vitro clinical studies of Theradux during the 2015 North American Cystic Fibrosis Foundation Conference.

The studies, which were financially supported by the Cystic Fibrosis Foundation and the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH/NHLBI), demonstrated that Theradux has an exclusive mucus-binding mechanism. The medication was also found to have a lack of toxicity and inflammation in pre-clinical, acute aerosol-inhalation trials. The company will present these results at the NIH/NHLBI Innovation Conference (Nov. 17, 2015) in Irvine, California.

Cystic fibrosis (CF) is an incurable, ultimately fatal inherited disorder that causes thick, sticky mucus to form in the lungs, pancreas, and other organs. In the lungs, thick mucus can damage tissue and block airways, making it difficult for patients to breathe and promoting lung infections. Although lung disease is responsible for more than 80% of CF-related deaths, CF has many other manifestations, including pancreatic insufficiency, gastrointestinal problems, endocrine disorders, and male infertility.

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