Constant Therapeutics has initiated a Phase II clinical study of TXA127, a treatment aimed at aiding in ischemic stroke recovery.
The first patient has now been dosed, marking a significant step in the development of this potential new therapy.
TXA127 is the company’s lead peptide product and a pharmaceutical formulation of the human peptide angiotensin-(1‐7).
The trial is a randomised, placebo-controlled, double-blind study, incorporating a hybrid, decentralised approach.
It is designed to evaluate the efficacy and safety of TXA127 in subjects aged 18 to 85 years old, six to 24 months following a stroke event.
The company plans to enrol 50 patients, with each participant receiving treatment for three months.
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The study is being carried out at Sheba Medical Center in Israel, in partnership with Sabar Health for home visits.
Apart from ischemic stroke recovery, TXA127 is being developed for Duchenne Muscular Dystrophy (DMD)-associated cardiomyopathy.
The compound demonstrated therapeutic activity in various animal models for diseases such as ischemic stroke, DMD, limb‐girdle muscular dystrophy (LGMD), congenital muscular dystrophy (MDC1A), Marfan Syndrome, and Epidermolysis Bullosa.
Constant Therapeutics CEO Rick Franklin said: “There are no drugs available to treat chronic stroke, but the design and logistics of clinical trials in these patients is particularly difficult.
“We are fortunate to have been able to put together the infrastructure needed, with the participation of Sabar Health and Sheba Medical Center.
“This unique combination will allow us to test TXA127 for this important unmet medical need.”
The company develops therapies that target the Alternative Renin-Angiotensin System.
In 2021, Constant announced that TXA127 entered the US National Institutes of Health (NIH)-funded clinical trial for Covid-19 at 60 US sites.