Bitterroot Bio has dosed the first participants in a Phase I trial investigating its candidate for the treatment of atherosclerotic cardiovascular disease.
The study involves healthy participants, who will receive subcutaneous administrations of BRB-002 – the US company’s cardio-immunology candidate.
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Atherosclerotic cardiovascular disease is a common but serious condition that involves the narrowing of arteries. The buildup of fats, cholesterol, and other substances in the vessel as plaque restricts blood flow.
There is around a 50% chance of developing atherosclerosis once over the age of 40, according to Heart Research Institute UK.
Bitterroot Bio has designed BRB-002 to inhibit the CD47 cell surface receptor which is widely expressed in vascular cells and tissues. The company, which emerged in June 2023 with a $145m Series A financing round, says that preclinical studies have demonstrated the drug’s ability to attenuate atherosclerosis in both prevention and established disease models.
The Phase I trial, being conducted in Brisbane, Australia, will evaluate the safety and tolerability of the therapy.
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By GlobalDataBitterroot Bio’s chief medical officer Craig Basson said: “The initiation of this Phase 1 trial is a vital step forward in our mission to address unmet cardiovascular needs, and marks Bitterroot’s transformation into a clinical-stage company.
“We are optimistic about the potential of BRB-002 to make a meaningful difference in the lives of patients and are committed to rigorously evaluating its safety and efficacy in the clinic.”
Also in early clinical phase in the atherosclerotic cardiovascular disease space is Silence Therapeutics. In November last year, the UK company reported positive results from a Phase I trial investigating its short interfering RNA therapy Zerlasiran.
The cardiovascular disease treatment space as a whole could undergo a major transformation with the emergence of high-profile weight loss drugs. Novo Nordisk’s blockbuster drug Wegovy, for example, may reduce cardiovascular risk by 20% for heart disease patients.
