AER002 / Aerium Therap - LARVOL DELTA

outSMART-LC: Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19) (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Michael Peluso, MD | Trial primary completion date: Jul 2025 ➔ Jul 2024

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

HPLC-MS/MS-based quantification of human monoclonal antibodies targeting SARS-CoV-2 in the presence of endogenous SARS-CoV-2 antibodies in human serum. (PubMed, Anal Bioanal Chem) - "To eliminate interference from endogenous anti-spike protein antibodies, an HPLC-MS/MS assay was developed to quantify the investigational monoclonal antibodies (AER001 and AER002) by targeting signature peptides spanning the monoclonal antibodies' CDR regions. In summary, the presented results show that ammonium sulphate precipitation and HPLC-MS/MS allow accurate and precise quantification of monoclonals in clinical studies. The developed methods demonstrate that HPLC-MS/MS can reliably quantify human monoclonal antibodies even when endogenous antibodies with overlapping specificities are present and are crucial for the clinical testing of two investigational COVID-19 monoclonals."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A First-in-Human Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics, and Neutralization Profile of Two Investigational Long-Acting Anti-SARS-CoV-2 Monoclonal Antibodies. (PubMed, Infect Dis Ther) - "AER001 and AER002 showed an acceptable safety profile and extended half-life. High serum neutralization activity was observed against D614G and Omicron BA.1 compared to the placebo group. These data support that LS-modified mAbs can achieve durability, safety, potency, and upper airway tissue penetration and will guide the development of the next generation of mAbs for COVID-19 prevention and treatment."

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

outSMART-LC: Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19) (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Michael Peluso, MD | Recruiting ➔ Active, not recruiting

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

outSMART-LC: Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Michael Peluso, MD | Enrolling by invitation ➔ Recruiting

Enrollment status • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

outSMART-LC: Anti-SARS-CoV-2 Monoclonal Antibodies for Long COVID (COVID-19) (clinicaltrials.gov) - P2 | N=30 | Enrolling by invitation | Sponsor: Michael Peluso, MD | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases