NGM621 IV / NGM Biopharma - LARVOL DELTA

A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19 (clinicaltrials.gov) - P1/2 | N=16 | Terminated | Sponsor: NGM Biopharmaceuticals, Inc | N=48 ➔ 16 | Trial completion date: Sep 2021 ➔ Mar 2021 | Recruiting ➔ Terminated; Due to the rapidly changing therapeutic landscape in the COVID-19 space and an assessment of unmet medical need, Part 2 of the study was cancelled (per protocol Section 4.3). Meanwhile, Part 1 of the study was completed.

Enrollment change • Trial completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 1 trial shows NGM621 for GA is well tolerated by study participants (Ophthalmology Times) - P1, N= 15; NCT04014777; Sponsor: NGM Biopharmaceuticals, Inc; "The phase 1 study of NGM621 (NGM Biopharmaceuticals), a novel, humanized, monoclonal IgG1 antibody, showed promising results that support the continued clinical development of the drug to treat geographic atrophy (GA). The drug was well tolerated without development of serious adverse effects, according to Charles C. Wykoff, MD, PhD....'Overactivation of the complement cascade has been implicated repeatedly in GA pathogenesis,' he explained. 'C3 represents the central point of convergence for the 3 activation pathways in the eye: the classical, lectin, and alternative pathways.'"

Media quote • P1 data

A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19 (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: NGM Biopharmaceuticals, Inc; Not yet recruiting ➔ Recruiting

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

NGM Bio to Present Safety and Pharmacokinetics Data from Phase 1 Study of NGM621 in Patients with Geographic Atrophy at American Academy of Ophthalmology (AAO) 2020 Virtual (GlobeNewswire) - "NGM Biopharmaceuticals, Inc...announced that data from its Phase 1 study of NGM621, a potent anti-complement C3 antibody, will be featured in a poster presentation at the American Academy of Ophthalmology (AAO) 2020 Virtual....Inhibition of Complement Component 3 in GA With NGM621: Phase 1 Dose-Escalation Study Results...Charles C. Wykoff, M.D..."

A Phase 1/2 Study to Assess the Safety, Tolerability and Pharmacokinetics of NGM621 in Healthy Subjects, and to Assess the Safety, PK and Efficacy in Subjects With Moderate to Severe ARDS Caused by COVID-19 (clinicaltrials.gov) - P1/2; N=48; Not yet recruiting; Sponsor: NGM Biopharmaceuticals, Inc

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease