froniglutide (PF1801) / ImmunoForge, PhaseBio Pharma - LARVOL DELTA

FROG: Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (clinicaltrials.gov) - P2 | N=39 | Recruiting | Sponsor: Immunoforge Co. Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2023 ➔ Sep 2023

Enrollment open • Trial initiation date • Dermatomyositis • Immunology • Myositis

FROG: Study Evaluating Efficacy and Safety of Froniglutide (PF1801) in Patients With Idiopathic Inflammatory Myopathy (clinicaltrials.gov) - P2 | N=39 | Not yet recruiting | Sponsor: Immunoforge Co. Ltd.

New P2 trial • Dermatomyositis • Immunology • Myositis

Amelioration of inflammatory myopathies by glucagon-like peptide-1 receptor agonist via suppressing muscle fibre necroptosis. (PubMed, J Cachexia Sarcopenia Muscle) - "GLP-1R agonist could be a novel therapy for PM that recovers muscle weakness and suppresses muscle inflammation through inhi biting muscle fibre necroptosis."

Journal • Immunology • Inflammation • Muscular Atrophy • Myositis • Targeted Protein Degradation • FASLG • HMGB1 • HMOX1 • IL6 • NQO1 • TNFA

Agonistic stimulation of Glucagon-like Peptide-1 Receptor ameliorated inflammatory myopathies through suppressing muscle fiber necroptosis (EULAR 2022) - "The inhibitory effect of PF1801 on myotube necroptosis was cancelled by compound C, an AMPK-kinase inhibitor, or MG132, a proteasome inhibitor, suggesting that PF1801 promoted ubiquitin-proteasome-mediated PGAM5 degradation through the activation of AMPK. GLP-1R agonist could be a novel therapy for PM that restores muscle strength as well as suppresses muscle inflammation through inhibiting muscle fiber necroptosis."

Myositis • Targeted Protein Degradation • FASLG • HMGB1 • HMOX1 • IL6 • NQO1 • TNFA

[VIRTUAL] Glucagon-like Peptide-1 Receptor Agonist Suppresses Muscle Fiber Necroptosis and Muscle Inflammation and Ameliorates Muscle Weakness in Experimental Polymyositis (ACR-CONVERGENCE 2021) - "GLP-1R agonist could be a novel therapy for PM that recover muscle weakness and suppress muscle inflammation through suppressing muscle fiber necroptosis."

Immunology • Inflammation • Myositis • FASLG • HMGB1 • HMOX1 • IL6 • NQO1 • TNFA

Immunoforge’s ’PF1801’ Is Designated as Orphan Drug by FDA (PRNewswire) - "Immunoforge...announced that their new drug candidate PF1801 has been designated as the FDA orphan drug for treatment of the Duchenne muscular dystrophy on January 25....Immunoforge will be granted the following benefits from the FDA: waiver of qualified clinical trials costs and FDA expedited review during clinical trials for the Duchenne muscular dystrophy, as well as 7-years of exclusive right on marketing upon market approval....Immunoforge plans to obtain approval from the US FDA for phase 2 clinical trials of the Duchenne muscular dystrophy and promote clinical trials in the second half of 2021..."

New P2 trial • Orphan drug • Duchenne Muscular Dystrophy