remlarsen (MRG-201) / Viridian Therap - LARVOL DELTA

Epigenetic regulation of angiogenesis and its therapeutics. (PubMed, Genomics Inform) - "In recent years, epigenetic drugs, such as DNA methyltransferase inhibitors (e.g., azacitidine, decitabine), histone deacetylase inhibitors (e.g., vorinostat, romidepsin), and BET inhibitors (e.g., JQ1), have emerged as promising therapeutic strategies for targeting abnormal angiogenesis...Additionally, miRNA modulators, such as MRG-110 and MRG-201, provide precise regulation of angiogenesis-related pathways, demonstrating significant therapeutic potential in preclinical models. This review underscores the intricate interplay between epigenetic regulation and angiogenesis, highlighting key mechanisms and therapeutic applications. Advancing our understanding of these processes will enable the development of more effective and targeted epigenetic therapies for angiogenesis-related diseases, paving the way for innovative clinical interventions."

Journal • Review • Atherosclerosis • Cardiovascular • Diabetic Retinopathy • Gene Therapies • Oncology • Retinal Disorders

A lung targeted miR-29 mimic as a therapy for pulmonary fibrosis. (PubMed, EBioMedicine) - "Collectively, our results provide support for the development of the peptide-conjugated MRG-229 mimic as a potential therapy in humans with IPF."

Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • MIR29A • PDGFB • TGFB1

Efficacy, Safety, and Tolerability of Remlarsen (MRG-201) Following Intradermal Injection in Subjects With a History of Keloids (clinicaltrials.gov) - P2; N=14; Completed; Sponsor: miRagen Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Fibrosis

"3/n Rusty Montgomery @rmontonio of MiRagen: The Mir-29 mimic Remlarsen has hit fibrosis targets in a phase 1 trial of Keloid formation - a phase II trial is happening #AntiKeloid #CureScarring" (@KaminskiMed)

P1 data • P2 data • Fibrosis • Immunology

A microRNA-29 mimic (remlarsen) represses extracellular matrix expression and fibroplasia in the skin. (PubMed, J Invest Dermatol) - "miR-29 mimics prevent pulmonary fibrosis in mouse models but have not previously been tested in the skin. Biomarker expression translated to clinical proof-of-mechanism; in a double-blinded, placebo-randomized, within-subject controlled clinical trial of single and multiple ascending doses of remlarsen in normal healthy volunteers, remlarsen repressed collagen expression and the development of fibroplasia in incisional skin wounds. These results suggest that remlarsen may be an effective therapeutic to prevent formation of a fibrotic scar (hypertrophic scar or keloid) or to prevent cutaneous fibrosis, such as scleroderma."

Biomarker • Journal

Miragen reports first quarter 2020 financial results and provides corporate update (Miragen Therapeutics Press Release) - "Idiopathic Pulmonary Fibrosis (MRG-229): miRagen expects to report additional preclinical safety and efficacy data for MRG-229 during the second quarter of 2020....Cutaneous and Ocular Fibrosis (Remlarsen): The Company is currently working to complete its analysis of the one-year primary endpoint data for its Phase 2 clinical trial of remlarsen. Due to the potential impact of the COVID-19 pandemic on clinical sites, the Company cannot accurately predict when it will report the final topline data from this clinical trial, which was previously expected to be released in the second half of 2020."

P2 data • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

"Any thoughts on Miragen mRNA program as possible Covid19 solutions??? mRG201" (@thebigcheese77)

Potential IPF therapy remlarsen mimicking RNA molecule effective in mouse model (Pulmonary Fibrosis News) - "Naftali Kaminski, MD...commented that, coupled with prior observations in IPF patients, these results 'support the role of microRNA-29 in pathologic fibrosis, as well as the use of microRNA-29 replacements as potential therapeutics in pulmonary fibrosis.' 'I am very excited about the potential role of miRagen's microRNA-29 mimics, which is being facilitated by our collaboration through the NIH-[National Heart, Lung, and Blood Institute] funded CADET program,' added Kaminski..."

Media quote

Efficacy, Safety, and Tolerability of MRG-201 Following Intradermal Injection in Subjects With a History of Keloids (clinicaltrials.gov) - P2; N=14; Active, not recruiting; Sponsor: miRagen Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Aug 2019 ➔ Apr 2020; Trial primary completion date: Aug 2019 ➔ Apr 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

Remlarsen: Patent expiry related to compositions of matter and methods of use in US in September 2035 (Miragen Therapeutics) - Annual Report 2018

Patent