AMTX-100 CF3 / Amytrx Therap - LARVOL DELTA

Anti-inflammatory control of human skin keratinocytes by targeting nuclear transport checkpoint. (PubMed, Skin Health Dis) - P1/2 | "The control of inflammatory response in human KCs by NTCI is attributed to the inhibition of nuclear import of proinflammatory TFs. The protection of human KCs by NTCI, adds new perspectives to the completed Phase two clinical trial of the NTCI (AMTX-100 CF) for AD (NCT04313400)."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Oncology • Psoriasis • CXCL8 • IL1B • IL6 • STAT3 • TNFA • TSLP

Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=91 | Completed | Sponsor: Amytrx Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

AMTX-100, a Nuclear Transport Inhibitor, Attenuates Inflammatory Cytokine Production in vitro and Following UV Mediated Skin Inflammation in a Mouse Model of Cutaneous Lupus Erythematosus in vivo (ACR Convergence 2023) - "We conclude that AMTX-100 reduces Type I IFN and NF-kB-dependent inflammatory cytokines from DNA activated human monocytes in vitro . While AMTX-100 had a modest inhibitory effect on NET formation in response to PMA and ionophore stimulation, it did not attenuate NET formation induced by ICs in vitro. When tested in vivo using the lupus-relevant UV skin exposure, we observed a dose-dependent inhibition of several NF-kB-dependent cytokines as well as ISGs."

Preclinical • Atopic Dermatitis • Cutaneous Lupus Erythematosus • Dermatitis • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Oncology • IFIT1 • IL1B • IL6 • STAT1

Amytrx Therapeutics' AMTX-100 Phase 1 Clinical Trial Data Presented at Revolutionizing Atopic Dermatitis Conference (PRNewswire) - "Amytrx Therapeutics...announced that their abstract from the Revolutionizing Atopic Dermatitis (RAD) Conference has been published in the British Journal of Dermatology. The abstract, featured at the RAD Conference earlier this year in Washington, DC highlights exciting data that demonstrates the promising safety, tolerability, and efficacy outcomes observed with AMTX-100 in a Phase 1 clinical trial in adults with mild to moderate atopic dermatitis."

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Amytrx Therapeutics Announces Open Enrollment for Phase 2b Clinical Trial of AMTX-100 CF3, a Promising Anti-Inflammatory Peptide Therapeutic for Atopic Dermatitis (PRNewswire) - "Amytrx Therapeutics...is pleased to announce the open enrollment for its highly anticipated Phase 2b clinical trial of a topical formulation of AMTX-100 CF3, a groundbreaking anti-inflammatory peptide therapeutic designed to treat patients suffering from mild to moderate atopic dermatitis....The trial's primary endpoints include improvement in disease severity, reduction in symptoms, and assessment of treatment safety."

Trial status • Atopic Dermatitis • Dermatology • Immunology

Patients with Mild to Moderate Atopic Dermatitis: A first-in-human, Open- label, Dose-escalating, Non-Randomized Clinical Trial with AMTX-100 (RAD 2023) - "The findings for this Phase I portion of an Adaptive Phase I/II protocol provides support for safety, tolerability, and efficacy of AMTX-100 CF 1.1% in adult patients with mild to moderate AD. AMTX-100 CF 1.1% has advanced into Phase II study including safety, efficacy, gene expression (skin and blood), and proteomics (blood) measurements throughout the study"

Clinical • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • FGF • FGF4 • IL13 • IL17A • IL22 • IL23A • IL33 • IL4 • IL5 • TSLP

Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=85 | Recruiting | Sponsor: Amytrx Therapeutics, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=85 | Active, not recruiting | Sponsor: Amytrx Therapeutics, Inc. | N=145 ➔ 85

Enrollment change • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Genomic control of inflammation in experimental atopic dermatitis. (PubMed, Sci Rep) - P1/2 | "Consequently, NTCI suppressed skin infiltration by inflammatory cells (eosinophils, macrophages, and CD4 + T lymphocytes), and reduced MC903-evoked proliferation of Ki-67-positive cells. Thus, we highlight the mechanism of action and the potential utility of topical NTCI for treatment of AD undergoing Phase 1/2 clinical trial (AMTX-100 CF, NCT04313400)."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Oncology • CD4 • CSF2 • CXCL8 • IFNG • IL13 • IL1B • IL33 • IL4 • IL6 • TSLP

What's New in Topicals for Atopic Dermatitis? (PubMed, Am J Clin Dermatol) - "First-line therapy for acute management of AD includes topical therapies such as corticosteroids, calcineurin inhibitors, and, more recently, the phosphodiesterase inhibitor crisaborole...This review summarizes selected therapeutic topical agents in later phases of development that target various aspects in the pathogenesis of AD such as Janus kinase inhibition (ruxolitinib and delgocitinib), phosphodiesterase-4 inhibition (roflumilast and difamilast), aryl hydrocarbon modulation (tapinarof), and modulation of the microbiome. We also review novel targeted therapies that are in early phase clinical trials, including AMTX-100, BEN-2293, and PRN473. Preliminary findings on efficacy and tolerability of most of these agents are promising, but further studies are warranted to evaluate the long-term safety and efficacy of these novel agents against the current standard of care."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2 | N=145 | Active, not recruiting | Sponsor: Amytrx Therapeutics, Inc. | Trial completion date: Jan 2023 ➔ Jan 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=145; Active, not recruiting; Sponsor: Amytrx Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Amytrx Therapeutics Emerges from Stealth to Develop Novel Therapies for Inflammatory Diseases with Lead Program AMTX-100 Currently in Clinical Development for Dermatologic Indications (PRNewswire) - "FDA acceptance of topical AMTX-100 IND application for mild to moderate atopic dermatitis (eczema); Phase 1/2b clinical trial underway..."

New P1/2 trial • Atopic Dermatitis

Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis (clinicaltrials.gov) - P1/2; N=145; Recruiting; Sponsor: Amytrx Therapeutics, Inc.

Clinical • New P1/2 trial