University of Louisville

Poster Title

Phase 1A Clinical Study for Q-Griffithsin Intranasal Spray for Prevention of Coronavirus

Grade Level at Time of Presentation

Senior

Major

Neuroscience

Minor

Public Health

Institution 22-23

University of Louisville

KY House District #

4

KY Senate District #

24

Department

Department of Pharmacology and Toxicology

Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly transmissible virus that causes acute respiratory disease with possible long-term complications, known as coronavirus disease 2019 (COVID-19). Griffithsin (GRFT; including the oxidation-resistant variant Q-GRFT used in this study) is an algal carbohydrate-binding protein exhibiting antiviral effects against many enveloped viruses, including all major variants of SARS- CoV-2 reported to date. Q-GRFT has been recombinantly manufactured in Nicotiana benthamiana plants, thoroughly purified, and formulated as an intranasal spray designed to be developed as a non-vaccine broad-spectrum prophylactic product for acute use. This is the first-in-human, randomized, double-blind, placebo-controlled study. The aims were to assess safety, tolerability, and pharmacokinetics of a single 3 mg dose of Q-GRFT. A total of eighteen healthy adult volunteers (aged 24-54 years; twelve Q-GRFT product, six placebo) were recruited. Mucosal and plasma Q-GRFT concentrations were measured by ELISA . Participants completed a Brief Smell Identification Test (BSIT) and a general quality of life assessment questionnaire (SF-12). The surveys showed no impact on quality of life or sense of smell in both active and placebo groups. The pharmacokinetic data indicates that Q-GRFT administered intranasally maintained quantifiable levels (>15 ng/mL) in nasal passages and the nasopharynx for up to 24 hours, while the drug substance was rapidly cleared from the oropharyngeal mucosa after 1 hour. There was no indication of systemic absorption or distribution of Q-GRFT. In vitromicroneutralization assays using nasopharyngeal swab samples suggested that Q-GRFT product significantly boosted anti-SARS-CoV-2 activity in the nasopharynx for up to 6 hours. The results support proceeding to a repeat dose trial in healthy volunteers. Commercialization of such a product provides a new means for immediate protection against SARS-CoV-2 infection, which would be beneficial for front-line healthcare workers, first responders, and other vulnerable populations with weakened immune systems.

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Phase 1A Clinical Study for Q-Griffithsin Intranasal Spray for Prevention of Coronavirus

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a highly transmissible virus that causes acute respiratory disease with possible long-term complications, known as coronavirus disease 2019 (COVID-19). Griffithsin (GRFT; including the oxidation-resistant variant Q-GRFT used in this study) is an algal carbohydrate-binding protein exhibiting antiviral effects against many enveloped viruses, including all major variants of SARS- CoV-2 reported to date. Q-GRFT has been recombinantly manufactured in Nicotiana benthamiana plants, thoroughly purified, and formulated as an intranasal spray designed to be developed as a non-vaccine broad-spectrum prophylactic product for acute use. This is the first-in-human, randomized, double-blind, placebo-controlled study. The aims were to assess safety, tolerability, and pharmacokinetics of a single 3 mg dose of Q-GRFT. A total of eighteen healthy adult volunteers (aged 24-54 years; twelve Q-GRFT product, six placebo) were recruited. Mucosal and plasma Q-GRFT concentrations were measured by ELISA . Participants completed a Brief Smell Identification Test (BSIT) and a general quality of life assessment questionnaire (SF-12). The surveys showed no impact on quality of life or sense of smell in both active and placebo groups. The pharmacokinetic data indicates that Q-GRFT administered intranasally maintained quantifiable levels (>15 ng/mL) in nasal passages and the nasopharynx for up to 24 hours, while the drug substance was rapidly cleared from the oropharyngeal mucosa after 1 hour. There was no indication of systemic absorption or distribution of Q-GRFT. In vitromicroneutralization assays using nasopharyngeal swab samples suggested that Q-GRFT product significantly boosted anti-SARS-CoV-2 activity in the nasopharynx for up to 6 hours. The results support proceeding to a repeat dose trial in healthy volunteers. Commercialization of such a product provides a new means for immediate protection against SARS-CoV-2 infection, which would be beneficial for front-line healthcare workers, first responders, and other vulnerable populations with weakened immune systems.