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All Studies   Meta Analysis    Recent:   

A randomized, double-blind, Phase 1 study of IN-006, an inhaled antibody treatment for COVID-19

Aug 2022  
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35th treatment shown to reduce risk in March 2022
 
*, now known with p = 0.0000009 from 7 studies, recognized in 27 countries. Efficacy is variant dependent.
Lower risk for hospitalization, progression, and recovery.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,800+ studies for 60+ treatments. c19early.org
Phase 1 study of 23 healthy adults showing inhaled regdanvimab (IN-006) was well tolerated after single doses of 30mg and 90mg and 7 daily 90mg doses. High concentrations were achieved in nasal fluids and serum, over 1000 times the inhibitory concentration against SARS-CoV-2 for over 24 hours.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for omicron BA.2, BA.4, BA.5 Haars, ХВВ.1.9.1, XBB.1.9.3, XBB.1.5.24, XBB.1.16, XBB.2.9, BQ.1.1.45, CL.1, and CH.1.1 Pochtovyi.
Moench et al., 21 Aug 2022, Double Blind Randomized Controlled Trial, placebo-controlled, preprint, 17 authors, trial ACTRN12621001235897. Contact: moench@inhalon.com, lai@inhalon.com.
This PaperRegdanvimabAll
A randomized, double-blind, Phase 1 study of IN-006, an inhaled antibody treatment for COVID-19
Thomas R Moench, Lakshmi Botta, Brian Farrer, Jason D Lickliter, Hyunah Kang, Yoona Park, Cheolmin Kim, Marshall Hoke, Miles Brennan, Morgan D Mcsweeney, Zachary Richardson, John B Whelan, Jong Moon Cho, Soo Young Lee, Frances Faurot, Jeff Hutchins, Samuel K Lai
doi:10.1101/2022.08.17.22278748
Rationale: Although COVID-19 is predominantly a respiratory tract infection, current antibody treatments are administered by systemic dosing. We hypothesize that inhaled delivery of a mucotrapping monoclonal antibody would provide a more effective and convenient treatment for COVID-19. Objective: We investigated the safety, tolerability, and pharmacokinetics of IN-006, a reformulation of regdanvimab, an approved intravenous treatment for COVID-19, for nebulized delivery by a handheld nebulizer. Methods: A Phase 1 study was conducted in healthy volunteers. Study staff and participants were blinded to treatment assignment, except for pharmacy staff preparing the study drug. The primary outcomes were safety and tolerability. Exploratory outcomes were pharmacokinetic measurements of IN-006 in nasal fluid and serum. Results: Twenty-three participants were enrolled and randomized across two single dose and one multiple dose cohorts. There were no serious adverse events (SAEs). All enrolled participants completed the study without treatment interruption or discontinuation. All treatment-emergent adverse events were transient, non-dose dependent, and were graded mild to moderate in severity. Nebulization was well tolerated and completed in a mean of 6 minutes in the high dose group. Mean nasal fluid concentrations of IN-006 in the multiple dose cohort were 921 µg/g of nasal fluid at 30 minutes after dosing and 5.8 µg/g at 22 hours. Mean serum levels in the multiple dose cohort peaked at 0.55 µg/mL at 3 days after the final dose. Conclusions IN-006 was well-tolerated and achieved concentrations in the respiratory tract orders of magnitude above its inhibitory concentration. These data support further clinical development of
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