Australian biotech touts a positive mid-stage data readout — with old Shire drug

07 Feb 2023
endpts.com
Clinical ResultPhase 2Phase 1AcquisitionGene Therapy
A quiet biotech is reporting some positive data in a rare fibrotic disease. Certa Therapeutics — based in Melbourne, Australia — reported Monday that a Phase II trial showed “significant improvements across multiple efficacy measures” in patients with scleroderma, such as a systemic sclerosis index and skin scores. The main goal of the study, per Certa, was to examine the pharmacokinetics, pharmacodynamic effects and safety of FT011 in patients with scleroderma, a rare autoimmune disease that can cause inflammation in the skin and other parts of the body, like the lungs. Also known as crest syndrome, it has been associated with chronic hardening and tightness of the skin. But Certa also tracked a number of efficacy measures to see if the drug works. The trial recruited 30 adults that were randomly assigned to either a placebo group or one of two dose groups: 200mg or 400mg orally daily for 12 weeks. After those 12 weeks, Certa saw “clinically meaningful improvement in 60 percent of patients” treated with the 400mg dose of the therapy in a Phase II study, adding that it saw a p-value of p=0.019 versus placebo. Investigators also looked at a metric called a CRISS score, which predicts a patient’s chances from 0 to 1 of improvement based on five variables, including skin thickness and lung function. Three patients who were on FT011 achieved the maximum CRISS score of 1, Certa added. The biotech is running an open-label extension study for an additional nine months after the initial 12-week study. CEO Darren Kelly said in a statement that the readout “paves the way for a confirmatory global Phase III study.” A query to the Australian biotech was not immediately returned to Endpoints News . FT011 was originally developed by a company called Fibrotech, which had taken the drug through a Phase Ia study in diabetic neuropathy. Shire then acquired Fibrotech in 2014 when it bought the company for $75 million plus up to $600 million milestones — before Takeda bought out Shire in 2019. Certa, led by several former Fibrotech execs, including ex-CEO Kelly, then picked up the drug and was able to start a Phase II trial in 2021. Certa is not the only biotech that has been working on the rare disease. Cell and gene therapy biotech Castle Creek Biosciences has been working on FCX-013, a gene therapy for moderate and severe forms of scleroderma. Boehringer Ingelheim’s Ofev is also approved for interstitial lung disease associated with systemic sclerosis or scleroderma.
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