NGM621 Intravitreal / NGM Biopharma - LARVOL DELTA

CATALINA: A Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) - P2 | N=320 | Completed | Sponsor: NGM Biopharmaceuticals, Inc | Active, not recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Aug 2022 | Trial primary completion date: Dec 2022 ➔ Aug 2022

Trial completion • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Safety and Efficacy of NGM621, An Anti-Complement C3 Antibody for Treatment of Geographic Atrophy: Results from the Phase II CATALINA Study (Macula 2023) - P2 | "The CATALINA trial did not meet its primary endpoint but did demonstrate an acceptable safety profile with no evidence of increased CNV conversion. Complex lesions, coupled with potential methodology limitations with FAF grading, may have impacted interpretation. Correction of these factors may demonstrate signs of efficacy, warranting further analyses, which are ongoing."

Clinical • P2 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Immunology • Inflammation

Geographic Atrophy: Targeting the Complement Pathway (Retina Today) - "To date, no treatments are approved to reverse, prevent, or reduce the rate of geographic atrophy (GA) progression-an area of urgent unmet medical need as the population ages. A leading contributor to the pathogenesis of GA is complement system-mediated inflammation and retinal cell degeneration. Genome-wide association studies identified polymorphisms in a number of complement proteins among patients with AMD. In addition, patients with GA had alterations in complement cascade components both systemically and within the eye. Active research is underway to find a treatment for GA, and most studies focus on the complement cascade."

Inhibition of Complement C3 in Geographic Atrophy with NGM621: Phase 1 Dose-Escalation Study Results. (PubMed, Am J Ophthalmol) - "In this small, open-labelled, 12-week phase 1 study, NGM621 was safe and tolerable when administered intravitreally up to 15 mg."

Journal • P1 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

CATALINA: A Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) - P2; N=320; Active, not recruiting; Sponsor: NGM Biopharmaceuticals, Inc; Recruiting ➔ Active, not recruiting; N=240 ➔ 320

Clinical • Enrollment change • Enrollment closed • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

[VIRTUAL] Inhibition of complement C3 in geographic atrophy with NGM621: Phase 1 study results (ARVO 2021) - P1, P2 | "In this Phase 1 dose-escalation study, NGM621 up to 15 mg was well tolerated and had a favorable PK/PD profile in patients with GA. NGM621 is being further studied in GA in the ongoing Phase 2 CATALINA study (NCT04465955)."

P1 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders

NGM621 for geographic atrophy well tolerated in phase 1 study (Healio) - P1, N=15; NCT04014777; Sponsor: NGM Biopharmaceuticals, Inc; '"NGM621 was well tolerated up to 15 mg dosed twice in this phase 1 study with no safety signals, supporting the continued clinical development of NGM621,' Charles C. Wykoff, MD, PhD, said at the virtual Angiogenesis, Exudation, and Degeneration meeting....The novel monoclonal antibody potently inhibits C3 and prevents downstream activation of the complement cascade. The primary objective of the study was to evaluate the safety and tolerability of single and multiple intravitreal injections of NGM621 (NGM Biopharmaceuticals) in patients with geographic atrophy secondary to AMD. Additionally, researchers attempted to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of the antibody, Wykoff said."

Media quote

NGM Bio Presents Phase 1 Safety and Pharmacokinetics Data for NGM621, an Anti-Complement C3 Antibody, in Patients with Geographic Atrophy at the American Academy of Ophthalmology 2020 Virtual - P1, N=15; NCT04014777; Sponsor: NGM Biopharmaceuticals, Inc; "NGM Biopharmaceuticals...announced that findings from its Phase 1 clinical study of NGM621, an anti-complement C3 antibody, in patients with geographic atrophy (GA) were presented today at the American Academy of Ophthalmology 2020 Virtual....'The findings from this first-in-human study of NGM621 in patients with geographic atrophy give us important insights regarding the potential of this therapeutic to address this progressive and devastating disease,' said Dr. Wykoff. 'The favorable safety and tolerability profile seen in this study, combined with the potential for every other month dosing suggest NGM621 may be valuable as a complement C3 inhibitor to treat geographic atrophy. I look forward to continuing to advance our clinical understanding of NGM621 in the ongoing, double-masked Phase 2 CATALINA study.'"

Media quote • P1 data

[VIRTUAL] PO397: Inhibition of Complement Component 3 in GA With NGM621: Phase 1 Dose-Escalation Study Results (AAO 2020) - "Conclusion NGM621 up to 15 mg was well tolerated in this Phase 1 dose escalation study. NGM621 will be further studied in a Phase 2b study of GA."

P1 data • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Ophthalmology

Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) - P1; N=15; Completed; Sponsor: NGM Biopharmaceuticals, Inc; Active, not recruiting ➔ Completed; N=24 ➔ 15; Trial completion date: Dec 2020 ➔ May 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

NGM Bio Announces Initiation of Phase 2 CATALINA Study of NGM621 in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) (GlobeNewswire) - P2, N=240; CATALINA (NCT04465955); Sponsor: NGM Biopharmaceuticals, Inc; '''As a retina specialist who manages patients with GA, I see first-hand the progressive and eventually devastating impact this disease can have on patients’ quality of life. The insidious loss of vision leads to difficulty with everyday tasks and social isolation, in many cases robbing patients of their independence and ability to do things they enjoy. Often these patients live in fear of going blind, knowing that currently nothing can be done to slow their disease progression,' said Charles C. Wykoff, M.D...'Complement inhibition continues to be a promising approach to slowing GA progression. I am pleased to see NGM621 move into a rigorous Phase 2 study and am encouraged by the data to date with this antibody that blocks C3 activation. I look forward to seeing how NGM621’s C3 inhibition translates into clinical.'"

Media quote • P2 data

CATALINA: A Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) - P2; N=240; Recruiting; Sponsor: NGM Biopharmaceuticals, Inc

Clinical • New P2 trial • Age-related Macular Degeneration • Complement-mediated Rare Disorders • Dry Age-related Macular Degeneration • Gene Therapies • Ophthalmology • Retinal Disorders

NGM621 is a Potent Inhibitory Anti-Complement C3 Antibody in Development for Treatment of Geographic Atrophy (ARVO 2020) - "Furthermore, using an ocular complement activation model in cynomolgus monkeys, NGM621 demonstrated in vivo efficacy consistent with these in vitro properties. NGM621 is currently being evaluated in a Phase 1 clinical trial for safety and tolerability in patients with GA."

Study of NGM621 in Participants With Geographic Atrophy (clinicaltrials.gov) - P1; N=24; Active, not recruiting; Sponsor: NGM Biopharmaceuticals, Inc; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed