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Laboratory-based investigation of the efficacy and cell and molecular protective effects of fosamprenavir and its prodrug, amprenavir, in models of the human aerodigestive tract.

In vivo efficacy study of fosamprenavir in an LPR mouse model

• Johnston N, Samuels TL, Goetz CJ, Arnold LA, Smith BC, Seabloom D, Wuertz B, Ondrey F, Wiedmann TS, Vuksanovic N, Silvaggi NR, MacKinnon AC, Miller J, Bock J, Blumin JH. Oral and Inhaled Fosamprenavir Reverses Pepsin-Induced Damage in a Laryngopharyngeal Reflux Mouse Model. Laryngoscope. 2023 Jan;133 Suppl 1(Suppl 1):S1-S11. doi: 10.1002/lary.30242. Epub 2022 Jun 9. PMID: 35678265; PMCID: PMC9732152.

Protection against epithelial barrier disruption and downstream cancer-associated effects of weakly acidified pepsin in an in vitro model

• Samuels TL, Blaine-Sauer S, Yan K, Johnston N. Amprenavir inhibits pepsin-mediated laryngeal epithelial disruption and E-cadherin cleavage in vitro. Laryngoscope Investig Otolaryngol. 2023 Jun 22;8(4):953-962. doi: 10.1002/lio2.1102. PMID: 37621274; PMCID: PMC10446255.

Evaluation of a repurposing strategy, using FDA-approved HIV-1 protease inhibitor, fosamprenavir (commercial tablets) for symptoms of LPR.

• Phase II Proof of Concept Study: A 12-Week Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy of Oral Fosamprenavir for Laryngopharyngeal Reflux.

Protection against epithelial barrier disruption and downstream cancer-associated effects of weakly acidified pepsin encountered during proton pump inhibitor (PPI) recalcitrant GERD

• Blaine-Sauer S, Samuels TL, Yan K, Johnston N. The Protease Inhibitor Amprenavir Protects against Pepsin-Induced Esophageal Epithelial Barrier Disruption and Cancer-Associated Changes. Int J Mol Sci. 2023 Apr 5;24(7):6765. doi: 10.3390/ijms24076765. PMID: 37047737; PMCID: PMC10095080.

Protection against global transcriptomic changes caused by weakly acidified pepsin mimicking PPI-recalcitrant GERD

• Ergun P, Samuels TL, Mathison AJ, Liu T, Jin VX, Johnston N. Amprenavir Mitigates Pepsin-Induced Transcriptomic Changes in Normal and Precancerous Esophageal Cells. Int J Mol Sci. 2025 Jun 26;26(13):6182. doi: 10.3390/ijms26136182. PMID: 40649959; PMCID: PMC12250232.

Esophageal mucoadhesion and conversion of a novel fosamprenavir-sodium alginate formulation in an ex vivo porcine model (study underway)

Evaluation of the efficacy of a novel fosamprenavir-sodium alginate formulation designed for superior esophageal mucoadhesion and local esophageal delivery.

• Phase II Proof of Concept Study: Randomized, Double-blind, Placebo-Controlled
  
  Trial of Fosamprenavir-Sodium Alginate Administered Orally for 8 Weeks to Patients with Proton Pump Inhibitor Refractory Gastroesophageal Reflux Disease. Estimated Start: Sept 2026

Laboratory-based investigation of cell and molecular protective effects of fosamprenavir and its prodrug, amprenavir, in models of the human aerodigestive tract.

In vivo efficacy study of inhaled fosamprenavir in an LPR mouse model

• Johnston N, Samuels TL, Goetz CJ, Arnold LA, Smith BC, Seabloom D, Wuertz B, Ondrey F, Wiedmann TS, Vuksanovic N, Silvaggi NR, MacKinnon AC, Miller J, Bock J, Blumin JH. Oral and Inhaled Fosamprenavir Reverses Pepsin-Induced Damage in a Laryngopharyngeal Reflux Mouse Model. Laryngoscope. 2023 Jan;133 Suppl 1(Suppl 1):S1-S11. doi: 10.1002/lary.30242. Epub 2022 Jun 9. PMID: 35678265; PMCID: PMC9732152.

Pre-GLP safety testing of inhaled fosamprenavir and design of a laryngopharyngeal dry powder inhaler

• Lesnick A, Samuels TL, Seabloom D, Wuertz B, Ojha A, Seelig D, Ondrey F, Wiedmann TS, Hogan C, Torii E, Ouyang H, Yan K, Garcia GJM, Bock JM, Johnston N. Inhaled fosamprenavir for laryngopharyngeal reflux: Toxicology and fluid dynamics modeling. Laryngoscope Investig Otolaryngol. 2024 Jan 24;9(1):e1219. doi: 10.1002/lio2.1219. PMID: 38362183; PMCID: PMC10866582.
• Dey S, Jadcherla A, Johnston N, Bock JM, Garcia GJM. Optimizing dry powder inhaler for laryngopharyngeal reflux: Effects of particle size and breathing technique. Journal of Aerosol Science 2025 189, 106641.

GLP toxicologic assessment (to be completed late 2025)

Evaluation of the safety and efficacy a novel inhaled fosamprenavir formulation that offers targeted laryngopharyngeal delivery for reduced dosing.

• Phase I Safety/Efficacy Study