SAN DIEGO, CA (September 20, 2023) Hillhurst Biopharmaceuticals, Inc. (“Hillhurst”), a clinical-stage biopharmaceutical company focused on developing liquid drug products containing therapeutic gases, today announced the award of an approximately $3 million Phase 2b SBIR grant from the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.  This award, along with matching funds, will fund the company through a Phase 2a clinical study of HBI-002, an oral low dose carbon monoxide therapeutic candidate in patients with sickle cell disease (SCD). HBI-002 is targeted for the treatment of SCD.  Hillhurst anticipates initiating this study in Q1 2024.

“With this award, the NHLBI enables advancing HBI-002 into a population of individuals with sickle cell disease with the objective of addressing a significant unmet need,” said Andrew Gomperts, Hillhurst’s Chief Executive Officer.  “We believe our novel approach of targeting dual mechanisms to prevent vaso-occlusive crises, including reducing both sickling and inflammation, holds great promise.”

About Sickle Cell Disease

Sickle cell disease is a genetic disorder that causes severe vaso-occlusive pain crises and is associated with serious clinical consequences including stroke, heart disease, and kidney disease as well as premature death.  The average life expectancy of SCD patients in the US is only 45 years, reflecting the substantial unmet medical need.

About HBI-002

Hillhurst’s lead product, HBI-002, is an oral drug product candidate of low dose CO, with an administration route designed to enable chronic use in a home setting for patients suffering from sickle cell disease. Other potential disease targets are conditions associated with inflammation and cell death such as Parkinson’s disease.  A Phase 1 clinical study with HBI-002 in healthy subjects under IND has been successfully completed.

About Hillhurst

Hillhurst is a clinical stage company focused on its proprietary GLASS^TM platform, which enables novel drug products based on therapeutic gases that, up until now, have been limited by inhaled delivery, including a unique pipeline of novel liquid therapeutic candidates intended to treat patients with sickle cell disease, Parkinson’s disease, and acute pain.

This research is supported by the NHLBI under grant number 2R44HL131065-05, and its content is solely the responsibility of the authors and does not necessarily represent the official views of NIH.

To learn more about Hillhurst, please visit www.hillhurstbio.com.

CONTACT: Andrew Gomperts, President and CEO, hillhurstpress@hillhurstbio.com