First, the good news: Fresh Track’s atopic dermatitis treatment has strolled through a phase 1 study, a notable success for the first oral DYRK1A inhibitor to enter the clinic for an autoimmune condition.
The not-so-good news? To take the therapy forward, the biotech is considering anything from a licensing deal all the way through to the total sale of the company.
If Fresh Tracks does decide to accept an offer to be acquired or merge with another biopharma, it could mark a surprisingly short lifespan for the rebranded company, which traded as Brickell Biotech until as recently as September.
Today’s topline results came from the single ascending dose and multiple ascending dose parts of the phase 1 trial, which included a total of 89 people both with and without atopic dermatitis. The company touted the results as showing that FRTX-02 is a “generally safe and well-tolerated, once-daily oral treatment for a broad range of autoimmune and inflammatory diseases.”
With part one of the trial completed, Fresh Tracks intends to progress to part two, which will compare efficacy of once-daily oral doses of FRTX-02 to placebo in subjects with moderate-to-severe atopic dermatitis.
“These topline SAD and MAD data reinforce our enthusiasm for the continued development of FRTX-02 as a potential first-in-class therapy,” said CEO Andy Sklawer, who took on the role a week ago. “However, to fully unlock the potential of the company’s pipeline considering our current capital resources, we have determined it is prudent for us to initiate a comprehensive review of strategic options with the goal of maximizing shareholder value as we look to advance the clinical development of FRTX-02 and progress our earlier-stage assets.”
The company has signed up MTS Health Partners to help scope out options, which could range from “financing, sale or licensing of assets, acquisition, merger, business combination, or other strategic transaction or series of related transactions,” Fresh Tracks said.
The company has yet to release its latest earnings report but had $11.3 million on hand in cash and equivalents at the end of September, which was expected to last for at least 12 months.
The protein kinase known as dual-specificity tyrosine phosphorylation-regulated kinase 1 A has traditionally been considered a so-called “undruggable” target. Brickell picked up the rights to South Korean drug discovery company Voronoi's DYRK1A inhibitor platform, including FRTX-02, in 2021.
The aim of FRTX-02 is to restore immune balance by modulating both adaptive and innate immune responses in patients with autoimmune and inflammatory diseases. While Fresh Tracks was the first to enter the clinic with an oral DYRK1A inhibitor to treat autoimmune disease, these drugs are being studied in everything from Alzheimer’s to diabetes.