enuzovimab (HFB30132A) / HiFiBiO, Pharm-Sintez, Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry, Pharmsynthez - LARVOL DELTA

Population pharmacokinetics and pharmacodynamics of HFB30132A, a monoclonal antibody against SARS-CoV-2, in healthy Chinese and US subjects. (PubMed, Int J Antimicrob Agents) - P1 | "These findings are useful for drug development in the future. Clinical trial registration: ClinicalTrial.gov NCT04590430, NCT05275660."

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

Safety, tolerability, pharmacokinetics, and immunogenicity of an anti-SARS-CoV-2 monoclonal antibody HFB30132A after single dose intravenous administration in healthy Chinese subjects: a phase 1, randomized, double-blind, placebo-controlled study. (PubMed, Front Pharmacol) - P1 | "Our data support further clinical development of HFB30132A. Clinical Trial Registration: https://clinicaltrials.gov, identifier: NCT05275660."

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

Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: HiFiBiO Therapeutics | Active, not recruiting ➔ Completed | Trial primary completion date: Apr 2021 ➔ Jul 2021

Trial completion • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Chinese Healthy Adults (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: HiFiBiO Therapeutics

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Pharmsynthez and IBCh RAS to Develop HiFiBiO Therapeutics Against Covid-19 [Google translation] (Vademecum) - "Rusnano portfolio company Pharmsynthez and Institute of Bioorganic Chemistry named after academicians M.M. Shemyakin and Yu.A. Ovchinnikov (IBCh RAS) signed an agreement with the biopharmaceutical company HiFiBio Therapeutics to launch the monoclonal antibody HFB30132A, developed against COVID-19, on the Russian market. Pharmsynthez will continue research in Russia, and the production of the drug will be organized on the basis of the IBCh RAS....In Russia, a randomized, double-blind, placebo-controlled study of the drug will be conducted by Pharmsynthez. The company will also receive exclusive rights to organize the production of the drug and bring it to the domestic market. The monoclonal antibody will be produced at the facilities of the IBCh RAS."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

HiFiBiO Therapeutics Announces Publication in Nature Communications on its SARS-CoV-2 Neutralizing Monoclonal Antibody (Businesswire) - "HiFiBiO Therapeutics...announced a publication in Nature Communications with its collaborators at Xinhua Hospital and Nankai University on the preclinical data for its SARS-CoV-2 neutralizing monoclonal antibody, HFB30132A1 (P4A1-2A in the manuscript)....As part of this study, scientists were able to demonstrate the engineered antibody’s optimized pharmacokinetic and safety profile by showing how a single administration of HFB30132A into rhesus monkeys infected with the SARS-CoV-2 virus results in complete viral clearance."

Preclinical • Infectious Disease • Novel Coronavirus Disease

Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: HiFiBiO Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

HiFiBiO Therapeutics Inks Partnership with Pharmsynthez and IBCh for the Clinical Development and Commercialization of its SARS-CoV-2 Neutralizing Antibody in Russia (Businesswire) - "HiFiBiO Therapeutics...aannounced a partnership with Russian pharmaceutical company, Pharmsynthez PJSC (MOEX: LIFE), and Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS (IBCh). The partnership aims to advance HFB30132A...through clinical development and commercial sale in Russia, pending approval from the Ministry of Health of the Russian Federation. An IND has been submitted to the Ministry of Health and clinical sites have been selected for a Phase I/II study....Company is currently dosing the second cohort of healthy volunteers in a Phase I ascending dose study..."

IND • Licensing / partnership • Trial status • Infectious Disease • Novel Coronavirus Disease

HiFiBiO Therapeutics Completes First Cohort of a Phase I Study of its SARS-CoV-2 Neutralizing Antibody for the Treatment and Prevention of COVID-19 (Businesswire) - "...primary data readout is expected in late 2020; HiFiBiO Therapeutics...today announced the successful completion of the first cohort of the Phase I study....A total of three cohorts will be dosed and evaluated....All available safety, tolerability, and PK data for each cohort will be reviewed and evaluated by the Dose Escalation Committee. The second cohort will be dosed after the first cohort data is reviewed and the antibody is determined to be safe. To date, no adverse events have been observed....Later this year, the Phase II/III study is planned to enroll high-risk adults with asymptomatic or mild to moderate COVID-19..."

New P2/3 trial • P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: HiFiBiO Therapeutics

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

AVL Bio, Covid-19 antibody treatment approved in US clinical trial [Google translation] (Maekyung Media Group) - "ABL901 (HFB30132A), a COVID-19 antibody treatment...received approval for Phase 1 clinical trials....Under the approval, the two companies will begin the first patient administration in the United States early next week. In phase 1 clinical trial, which focuses on safety confirmation, toxic reactions are confirmed by conducting a single ascending dose (SAD) in 24 healthy subjects in the United States. AVL Bio and Hi-Fi Bio plan to start phase 2/3 of global clinical trials, including the US, immediately after completing phase 1 clinical trials within one month. Clinical results are expected to come out in the first half of next year, and are being developed with the aim of commercialization in the summer."

P1 data • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

HiFiBiO Therapeutics Announces a Global Strategic Partnership With ABL Bio for the Co-Development of a SARS-CoV-2 Neutralizing Antibody (Businesswire) - "HiFiBiO Therapeutics...today announced a partnership agreement with South Korea-based ABL Bio to advance HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment of COVID-19 patients....The company...is planning a US Phase I single-IV administration ascending dose study....This Phase I study will be followed by global late-stage clinical trials in COVID-19 patients in late 2020."

Licensing / partnership • New P1 trial • Infectious Disease • Novel Coronavirus Disease

HiFiBiO submits IND application for SARS-CoV-2 neutralising antibody to treat Covid-19 patients (Pharmaceutical Business Review (PBR)) - "HiFiBiO Therapeutics...announced today the submission of an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) for a novel SARS-CoV-2 neutralizing antibody for the treatment of Covid-19 patients. The highly differentiated antibody, HFB30132A, has been rapidly identified, engineered, and evaluated in multiple preclinical studies. A Phase I single-IV administration ascending dose study will assess the safety, tolerability, and pharmacokinetics of HFB30132A in healthy volunteers."

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