FM101 / Future Medicine - LARVOL DELTA

A3AR antagonism mitigates metabolic dysfunction-associated steatotic liver disease by exploiting monocyte-derived Kupffer cell necroptosis and inflammation resolution. (PubMed, Metabolism) - "This study demonstrated that inhibiting A3AR via FM101 or genetic deletion alleviates MASLD by inducing mitochondrial dysfunction and subsequent necroptosis in MoKCs, establishing FM101 as a promising therapeutic strategy for MASLD."

Journal • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • ARRB1

FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis (clinicaltrials.gov) - P2a | N=60 | Recruiting | Sponsor: Future Medicine | Trial completion date: Jul 2022 ➔ Aug 2023 | Trial primary completion date: May 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Future Medicine Co., Ltd. (BIO 2022) - "Future Medicine is a clinical-stage Korean biotech company mainly developing small molecules that have promising drug profiles in three different disease areas 1) Inflammation/Fibrosis Our leading program, FM101, is an anti-inflammatory/Fibrotic agent that targets the A3AR pathway...Our strategy of oncology program development aims to solve unmet medical needs by implementing multifaceted approaches such as Immune (A2AAR), Metabolism (MDH1/2), Targeted (IRAK4/PIM1), and Mitotic (GSG2) driven-tumor pathway 3) Autoimmune disease Rheumatoid arthritis is our indication of interest. We have a competitive IRAK4 program that is preclinical-ready."

Fibrosis • Glaucoma • Hepatology • Immunology • Inflammation • Inflammatory Arthritis • Non-alcoholic Steatohepatitis • Oncology • Ophthalmology • Rheumatoid Arthritis • Rheumatology • IRAK4 • PIM1

FM101 Safety, Tolerability, Efficacy Study in the Patients With Ocular Hypertension (clinicaltrials.gov) - P1/2; N=64; Recruiting; Sponsor: Future Medicine; Trial completion date: Mar 2022 ➔ Jun 2023; Trial primary completion date: Dec 2021 ➔ Jan 2023

Clinical • Trial completion date • Trial primary completion date • Glaucoma

FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis (clinicaltrials.gov) - P2a; N=60; Recruiting; Sponsor: Future Medicine; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • MRI

FM101 Efficacy Study in Adults With Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis (clinicaltrials.gov) - P2a; N=60; Not yet recruiting; Sponsor: Future Medicine

Clinical • New P2a trial • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • MRI

[VIRTUAL] Integrated Efficacy of FMX101 4% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: Analyses of Efficacy in Clinically Relevant Subgroups of Patients (FCDC 2020) - "Abstract not available."

Clinical • Acne Vulgaris • Dermatology

Efficacy and Safety of a Novel Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: A Phase 3 Study. (PubMed, J Am Acad Dermatol) - "FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate to severe AV."

Clinical • Journal • P3 data • Acne Vulgaris • Dermatology

Formulation and Profile of FMX101 4% Minocycline Topical Foam for the Treatment of Acne Vulgaris. (PubMed, J Clin Aesthet Dermatol) - "FMX101 4% appeared to be safe, effective, and well tolerated for the treatment of non-nodular inflammatory lesions in moderate-to-severe acne vulgaris. In conclusion, the topical formulation of minocycline in FMX101 4% represents a unique treatment for acne vulgaris and a viable alternative to oral administration."

Journal • Acne Vulgaris • Dermatology