regdanvimab inhalation (IN-006) / Inhalon, Celltrion - LARVOL DELTA

A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in healthy volunteers. (PubMed, EBioMedicine) - P1 | "IN-006 was well-tolerated and achieved concentrations in the respiratory tract orders of magnitude above the IC50 range typical of antiviral mAbs. These data support further development of nebulized delivery of antiviral mAbs for respiratory infectious disease."

Clinical • Journal • P1 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Stable nebulization and muco-trapping properties of regdanvimab/IN-006 support its development as a potent, dose-saving inhaled therapy for COVID-19. (PubMed, Bioeng Transl Med) - "Finally, nebulized delivery of IN-006 resulted in 100-fold greater mAb levels in the lungs of rats compared to serum, in marked contrast to intravenously dosed mAbs. These results not only support our current efforts to evaluate the safety and efficacy of IN-006 in clinical trials, but more broadly substantiate nebulized delivery of human antiviral mAbs as a new paradigm in treating SARS-CoV-2 and other respiratory pathologies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Serbia’s Zdravlje to make Celltrion COVID-19 treatment available in Serbia [Google translation] (SeeNews) - "Serbian drug maker Zdravlje has signed an agreement with Celltrion Healthcare Hungary to make regdanvimab...available for patients in Serbia and the Western Balkans...Global Phase III clinical trial showed regdanvimab significantly reduced the risk of COVID-19 related hospitalisation or death by 72% in patients at a high-risk of progressing to severe COVID-19 and 70% for all patients."

Licensing / partnership • Novel Coronavirus Disease

Inhalon Doses First Patient in Phase 1 Study of Inhaled IN-006 to Treat COVID-19 (PRNewswire) - "Inhalon Biopharma...announced that the first patient has been dosed in a Phase 1 safety and tolerability study of IN-006 in healthy volunteers. IN-006 is an inhaled, muco-trapping formulation of regdanvimab."

Trial status • Infectious Disease • Novel Coronavirus Disease

A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of an Inhaled Antibody in Healthy Volunteers (ANZCTR) - P1; N=24; Not yet recruiting; Sponsor: Inhalon Biopharma, Inc.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease

Celltrion begins developing inhaled version of Regkirona in Australia (Korea Biomedical Review) - "Celltrion said that it has received approval from the Therapeutic Goods Administration (TGA) of Australia to conduct a phase 1 clinical trial plan for the inhalational formulation of Regkirona, a Covid-19 treatment. Inhalon Biopharma...will administer the treatment to 24 healthy subjects in the first phase of the clinical trial, followed by a phase 2 clinical trial for efficacy evaluation within this year."

New P1 trial • New P2 trial • Infectious Disease • Novel Coronavirus Disease

Inhalon Collaborates with Celltrion, Inc. to Develop Nebulized Form of Regdanvimab to Treat COVID-19 Patients at Home (PRNewswire) - "Topline Results Expected in 2022....Inhalon Biopharma, Inc....announced it is partnering with Celltrion, Inc. to develop IN-006, an inhaled form of regdanvimab, for treating patients with COVID-19....Inhalon has announced plans to complete a Phase 1 safety and tolerability study of nebulized regdanvimab in healthy volunteers by the end of the year. The study is funded by a $7 million contract from the U.S. Army Medical Research & Development Command."

Licensing / partnership • P1 data • Trial completion • Infectious Disease • Novel Coronavirus Disease

Inhalon Biopharma Receives $7 Million from USAMRDC to Study Inhaled “Muco-trapping“ Antibody for the Treatment of COVID-19 (PRNewswire) - "Human Studies to Start mid-2021....Inhalon Biopharma...announced that it has been awarded a $7 million contract by the U.S. Army Medical Research & Development Command (USAMRDC) to conduct a placebo-controlled Phase 1/2a study of IN-006 in COVID-19 outpatients....Initial results of this study are expected in 2022."

Financing • New P1/2 trial • P1/2 data • Infectious Disease • Novel Coronavirus Disease