Hillhurst Biopharmaceuticals Receives Study May Proceed Letter From US FDA to Initiate Phase 1 Clinical Trial of HBI-002
SAN DIEGO, April 27, 2021 /PRNewswire/ -- Hillhurst Biopharmaceuticals Inc. ("Hillhurst"), a clinical-stage biopharmaceutical company focused on developing oral therapies enabling the therapeutic use of low dose carbon monoxide (CO), today announced that the company has received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) permitting the company to begin its Phase 1 trial for HBI-002, an oral CO therapeutic for the treatment of sickle cell disease (SCD). This research is supported by a competitive Phase 2 SBIR grant from the National Heart, Lung, and Blood Institute (NHLBI).
"We are very pleased that Hillhurst's first IND has been favorably reviewed," said Edward Gomperts, MD, company co-founder and emeritus professor at the University of Southern California. "This represents a major milestone as our lead product candidate, HBI-002, advances into the clinic. We look forward to embarking on our next chapter as a clinical-stage company, harnessing our platform to evaluate the therapeutic potential of low dose carbon monoxide to prevent vaso-occlusive crises and transform the lives of patients with sickle cell disease."
The Phase 1 clinical trial is a multi-part study, incorporating both single and multiple dose cohorts to assess the safety, tolerability and pharmacokinetics of HBI-002 in healthy subjects, and is expected to begin in mid-2021.
There is substantial literature, both clinical and preclinical, supporting a potential therapeutic role for low dose CO treatment of SCD that has a unique dual mechanism of action: reduction of inflammation and cell death and blocking the polymerization of hemoglobin.
About Sickle Cell Disease
To learn more about Hillhurst, please visit www.hillhurstbio.com.
SOURCE Hillhurst Biopharmaceuticals, Inc.