Despite the high prevalence of LPR, socioeconomic cost and burden on quality of life, there is currently no effective medical therapy. Pepsin, detected in the airway of patients with LPR and now known to cause inflammation and promote disease independent of gastric acid, is a key therapeutic target. Our cutting-edge research demonstrates fosamprenavir binds to and inhibits pepsin, preventing pepsin-mediated inflammation and tissue damage. Using an innovative delivery approach, N-Zyme Biomedical aims to provide local inhaled delivery of a low dose of fosamprenavir direct to the throat providing the first safe, effective and efficient treatment for the millions of people that suffer from LPR, addressing a significant unmet clinical need.» What is LPR?
Oral systemic administration of Fosamprenavir, the drug used to treat HIV, prevented pepsin-mediated laryngeal injury in an LPR model. Local inhalation treatment was effective at a much lower dose. It binds to pepsin and inhibits its enzymatic activity.
This award comes with a grant that will go towards the drug reformulation process.
Our Phase III Clinical trial to assess the efficacy of fosamprenavir for the treatment of LPR has been given the green light to begin by the Center for Drug Evaluation and Research in the FDA and the Medical College of Wisconsin IRB.
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