FRTX-02 / Voronoi, Fresh Tracks Therap - LARVOL DELTA

A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=89 | Terminated | Sponsor: Fresh Tracks Therapeutics, Inc. | N=129 ➔ 89 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2023 ➔ Feb 2023; Business Decision

Enrollment change • Trial primary completion date • Trial termination • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Fresh Tracks Therapeutics Announces Positive Topline Results from Single and Multiple Ascending Dose Parts of Phase 1 Study of Oral DYRK1A Inhibitor FRTX-02 (BioSpace) - P1 | N=129 | NCT05382819 | Sponsor: Fresh Tracks Therapeutics, Inc. | "FRTX-02 was generally safe and well-tolerated in all seven SAD cohorts and in the 75 mg and 150 mg MAD cohorts, with no discontinuations due to Treatment-Emergent Adverse Events ('TEAEs')....A dose-proportional increase in exposure was observed through all SAD and MAD cohorts. PK data from the 75 mg and 150 mg MAD cohorts achieved maximum plasma concentrations (Cmax) and area under the concentration-time curve (AUC) values at or above the pharmacologically active exposure levels observed across multiple nonclinical autoimmune and inflammatory disease models....FRTX-02 demonstrated a reduction in disease-relevant proinflammatory cytokines in whole blood, suggesting initial support for the FRTX-02 mechanism of action."

P1 data • PK/PD data • Atopic Dermatitis • Immunology • Inflammatory Bowel Disease • Psoriasis • Rheumatoid Arthritis

FRTX-02, a selective and potent inhibitor of DYRK1A, modulates inflammatory pathways in mouse models of psoriasis and atopic dermatitis. (PubMed, J Transl Autoimmun) - "Finally, in mouse models of psoriasis and atopic dermatitis, both oral and topical formulations of FRTX-02 reduced inflammation and disease biomarkers in a dose-dependent manner. These results support further studies of DYRK1A inhibitors, including FRTX-02, as potential therapies for chronic inflammatory and autoimmune conditions."

Journal • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • CD4 • IRAK4 • MYD88 • NF-κβ

Fresh Tracks Therapeutics Announces Publication of Preclinical Data for FRTX-02, a Potential First-in-Class Oral DYRK1A Inhibitor, in the Peer-Reviewed Journal of Translational Autoimmunity (GlobeNewswire) - “Fresh Tracks Therapeutics, Inc…announced publication of data from preclinical studies of FRTX-02, a potential first-in-class, orally bioavailable DYRK1A inhibitor, in the Journal of Translational Autoimmunity. The paper shows FRTX-02 to be a potent and selective inhibitor of DYRK1A with the potential to restore immune homeostasis by regulating adaptive and innate immune system responses in models of various autoimmune and inflammatory diseases….‘FRTX-02, to our knowledge, is the first and only clinical-stage, oral DYRK1A inhibitor being developed for patients with autoimmune diseases, and we look forward to reporting topline results from Part 1 (SAD and MAD) of the current Phase 1 study with FRTX-02 by the end of this quarter.’”

P1 data • Preclinical • Atopic Dermatitis • Immunology • Psoriasis • Rheumatoid Arthritis

A Safety, Tolerability and Preliminary Efficacy Study of BBI-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis (clinicaltrials.gov) - P1 | N=129 | Recruiting | Sponsor: Brickell Biotech, Inc.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Brickell Biotech Acquires Exclusive Rights to Phase 1-Ready DYRK1A Inhibitor Program and Novel Platform Targeting Autoimmune and Inflammatory Diseases (GlobeNewswire) - “Expect to initiate Phase 1 clinical study of lead DYRK1A inhibitor program, BBI-02, a potential first-in-class oral treatment for autoimmune and inflammatory diseases, in 2022. Acquisition includes rights to platform of DYRK1A inhibitors with potential to create next generation kinase inhibitors (NCEs) targeting neuroinflammatory and other autoimmune diseases. Brickell Biotech, Inc…announced it has entered into a definitive agreement with Voronoi Inc…that grants Brickell exclusive, worldwide rights to research, develop and commercialize novel therapeutics generated from a proprietary DYRK1A inhibitor platform….The initial lead program that Brickell will be advancing is BBI-02, a Phase 1-ready, highly selective and orally bioavailable DYRK1A inhibitor that has demonstrated compelling results in various preclinical models, including of atopic dermatitis and rheumatoid arthritis.”

M&A • New P1 trial • Atopic Dermatitis • Dermatology • Immunology • Rheumatoid Arthritis