Fresh Tracks Therapeutics Profile
Fresh Tracks Therapeutics, Inc. operates as a clinical-stage pharmaceutical company. The company striving to transform patient lives through the development of innovative and differentiated prescription therapeutics.
The company's pipeline intends to disrupt existing treatment paradigms and features several new chemical entities that inhibit novel targets with first-in-class potential for autoimmune, inflammatory, and other debilitating diseases. The company's strategy is to align this experience and clear vision to explore beyond the limitations of therapies by identifying, pursuing, and developing next-generation therapeutics that can be groundbreaking in their ability to help millions of people struggling with autoimmune, inflammatory, and other debilitating diseases.
Research and Development Programs
FRTX-02: A Potential First-in-Class Oral DYRK1A Inhibitor for the Treatment of Autoimmune and Inflammatory Diseases
FRTX-02, a novel, potent, highly selective, and orally bioavailable potential first-in-class, small molecule DYRK1A inhibitor that aims to restore immune balance in patients whose immune systems have become dysregulated. FRTX-02 has the potential to be a first-in-class therapy for the treatment of a wide array of debilitating autoimmune and inflammatory diseases.
FRTX-02 is the company's lead development-stage program and has demonstrated promising results in various preclinical models, including of atopic dermatitis (AD) and rheumatoid arthritis. In these models, FRTX-02 showed encouraging decreases in disease severity and reduction of pro-inflammatory cytokines compared to standard-of-care agents, such as Janus kinase (JAK) inhibitors and anti-tumor necrosis factor (TNF) biologics.
In May 2022, the company initiated a first-in-human Phase 1 clinical trial for FRTX-02 (FRTX-02-101) in Canada, which marks the first time an oral DYRK1A inhibitor intended for patients with autoimmune diseases has been administered in humans. FRTX-02-101 is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of FRTX-02 capsules in both healthy subjects and patients with AD. Parts 1A and 1B of the Phase 1 clinical trial were completed in the fourth quarter of 2022, and in March 2023, the company reported positive topline results. Part 2 of the study is planned to compare once-daily oral doses of FRTX-02 to placebo in subjects with moderate-to-severe AD and include an exploratory evaluation of efficacy. Part 2 is expected to enroll approximately 40 patients at up to 12 study centers.
FRTX-02 is covered by a composition of matter patent issued in the U.S., Japan, China, and other key countries through at least 2038, subject to patent term extensions and adjustments that may be available depending on how this early-stage asset is developed, as well as a pending Patent Cooperation Treaty (PCT) application, and other foreign and U.S. applications for FRTX-02, as of December 31, 2022.
FRTX-10: A covalent Stimulator of Interferon Genes (STING) inhibitor candidate for the Potential Treatment of Autoimmune, Inflammatory, and Rare Genetic Diseases
In February 2022, the company acquired exclusive, worldwide rights to research, develop, and commercialize a portfolio of novel, preclinical-stage oral Stimulator of Interferon Genes (STING) inhibitors. STING is a well-known mediator of innate immune responses.
STING is a key component of the cyclic GMP-AMP synthase (cGAS)-STING pathway, which plays an important role in the activation of innate immunity. cGAS acts as a DNA sensor, detecting DNA from sources, such as invading bacteria, viruses, and cellular debris that can arise from aging and tissue damage.
FRTX-10, the company's lead early-stage STING inhibitor candidate, is a novel, potent, and orally bioavailable covalent STING inhibitor that specifically targets the palmitoylation site of STING.
For FRTX-10, as of December 31, 2022, the company has two pending PCT applications and pending applications in the U.S., Japan, Europe, and other key countries. The company possesses an exclusive license directed to a library of compounds targeting/inhibiting STING, pharmaceutical compositions containing the same, and methods of their use, which are being evaluated.
Next-Generation Kinase Inhibitors: A Cutting-Edge Platform with the Potential to Produce Treatments for Autoimmune, Inflammatory, and Other Debilitating Diseases
In August 2021, the company acquired exclusive global rights to a cutting-edge platform of next-generation kinase inhibitors. This library of new chemical entities includes next-generation DYRK1 inhibitors, as well as other molecules that specifically inhibit Leucine-Rich Repeat Kinase 2 (LRRK2), CDC2-like kinase (CLK), and TTK protein kinase (TTK), also known as Monopolar spindle 1 (Mps1) kinases. A number of these drug candidates have the potential to penetrate the blood-brain barrier, presenting an opportunity to address neuroinflammatory conditions of high unmet need, such as Down Syndrome, Alzheimer's Disease, and Parkinson's Disease, while other peripherally acting novel LRRK2, TTK, and CLK kinase inhibitors could be developed in additional therapeutic areas within autoimmunity, inflammation, and oncology.
FRTX-02 (Phase 1 Part A and B) Clinical Trial Results
The Phase 1 clinical trial of FRTX-02 is a two-part, randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of FRTX-02 capsules in both healthy subjects and patients with atopic dermatitis (AD). Part 1A of the study was a single ascending dose (SAD) assessment, which enrolled a total of 56 healthy subjects across seven cohorts (single oral dose of 10 to 600 mg FRTX-02 or placebo). Part 1B of the study was a multiple ascending dose (MAD) assessment, which enrolled a total of 33 healthy subjects across three cohorts (75, 150, and 300 mg FRTX-02 or placebo, once-daily for 14 days). Part 2 of the study is planned to compare once-daily oral doses of FRTX-02 to placebo in subjects with moderate-to-severe AD and include an exploratory evaluation of efficacy.
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).
Pharmacokinetics (PK)
A dose-proportional increase in exposure was observed through all SAD and MAD cohorts. The PK data support once-daily oral dosing with FRTX-02.
Pharmacodynamics (PD)
As part of an exploratory PD assessment, ex vivo lipopolysaccharide (LPS)-stimulated cytokine assays were conducted. FRTX-02 demonstrated a reduction in disease-relevant proinflammatory cytokines in whole blood, suggesting initial support for the FRTX-02 mechanism of action.
License and Development Agreement with Voronoi
In August 2021, the company entered into a license and development agreement (the Voronoi License Agreement) with Voronoi Inc. (Voronoi), pursuant to which the company acquired exclusive, worldwide rights to research, develop, and commercialize FRTX-02 and other next-generation kinase inhibitors.
Exclusive License and Development Agreement with Carna
In February 2022, the company entered into an exclusive license agreement (the Carna License Agreement) with Carna Biosciences, Inc. (Carna), pursuant to which the company acquired exclusive, worldwide rights to research, develop, and commercialize Carna's portfolio of novel STING inhibitors.
Research and Development
For the year ended December 31, 2022, the company's research and development expenses were $14.0 million.
History
The company was founded in 2009. The company was formerly known as Brickell Biotech, Inc. and changed its name to Fresh Tracks Therapeutics, Inc. in September 2022.
