Hillhurst gets $6.3M funding for HBI-002 clinical study
14-day study to test safety, effects of low-dose, liquid carbon monoxide
Hillhurst Biopharmaceuticals said it’s been awarded $6.3 million to fund a Phase 2a clinical study to test the efficacy of HBI-002, its low-dose liquid formulation of carbon monoxide, in preserving dopaminergic neurons, those that are lost to Parkinson’s disease, with the goal of slowing or stopping disease progression.
The study is scheduled to launch in early 2025, and will involve 36 people diagnosed with Parkinson’s, according to Hillhurst. Over the course of 14 days, researchers will look at HBI-002’s safety, its pharmacokinetics — how it moves into, through, and out of the body — and its effects on certain biomarkers.
The funding consists of a $2 million grant from The Michael J. Fox Foundation for Parkinson’s Research and $4.3 million from the Farmer Family Foundation together with Massachusetts General Hospital.
“The study represents an important step in advancing groundbreaking therapies for neurodegenerative diseases, with support from patient advocacy and research funding organizations like The Michael J. Fox Foundation and the Farmer Family Foundation,” Hillhurst said in a company press release.
Protecting brain cells
Evidence has shown that small amounts of carbon monoxide (CO) may help protect brain cells in Parkinson’s. Preclinical studies have found that low doses of CO could help prevent brain cell damage. And studies have shown that people who smoke cigarettes seem to have a lower risk of developing Parkinson’s.
Researchers believe CO, a component of cigarette smoke, may play a protective role. Data suggest that low doses of CO could help protect the brain in Parkinson’s, a neurodegenerative disease marked by motor symptoms caused by the loss of dopaminergic neurons. Dopaminergic neurons are nerve cells that produce dopamine, a chemical involved in motor control.
HBI-002 contains a low dose of carbon monoxide in a liquid to be taken by mouth, rather than inhaled as a gas. In a rat model of Parkinson’s, HBI-002 outperformed a placebo at preserving dopaminergic neurons and resulted in more dopamine being released into the striatum, a brain region involved in motor control.
In a Phase 1 clinical study (NCT03926819) sponsored by Hillhurst, HBI-002 was found to be safe and to show appropriate pharmacokinetics in healthy adults. The company has also announced plans to test daily doses of HBI-002 to treat sickle cell disease in a small Phase 2 clinical study (NCT06144749).
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