Hillhurst Biopharmaceuticals, Inc.

SAN DIEGO, Dec. 20, 2023 /PRNewswire/ -- Hillhurst Biopharmaceuticals, Inc. ("Hillhurst"), a clinical stage biopharmaceutical company focused on developing liquid drug products containing therapeutic gases, announced today the completion of a financing that, together with non-dilutive sources, funds Phase 2a clinical studies in sickle cell disease and in a second clinical indication. The financing was led by Friedman Bioventure Fund with participation from new and existing investors. "The Hillhurst team has uncovered novel means of delivery that enable new uses of known therapeutic gases, overcoming challenges associated with inhaled delivery," said Andrew Gomperts, chief executive officer of Hillhurst Bio. "These funds will allow us to bring our lead drug product into patients in therapeutic areas with substantial unmet medical needs, with readouts expected in 2024." The planned Phase 2a clinical trial in subjects with sickle cell disease is an ascending multiple dose study with 14 days of daily dosing to assess the safety, tolerability, pharmacokinetics, and proof of concept efficacy of HBI-002. There is substantial literature, both clinical and preclinical, supporting a potential therapeutic role for low dose CO treatment of SCD. This treatment has a unique dual mechanism of action, including reduction of inflammation and cell death, as well as blocking the polymerization of sickle hemoglobin. About Sickle Cell Disease Sickle cell disease is a rare genetic disorder that causes severe vaso-occlusive pain crises and is associated with serious clinical consequences including stroke, heart disease, 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 Bio'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. About Hillhurst Biopharmaceuticals Hillhurst Bio is a clinical stage company focused on its proprietary GLASS™ 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. To learn more about Hillhurst Bio, please visit . SOURCE Hillhurst Biopharmaceuticals, Inc.

SAN DIEGO, Nov. 7, 2023 /PRNewswire/ -- Hillhurst Biopharmaceuticals, Inc. ("Hillhurst"), a clinical-stage biopharmaceutical company focused on developing liquid drug products containing therapeutic gases, today announced the award of an up to $5 million HEAL (Helping to End Addiction Long-term®) Initiative grant from the National Institutes of Health. The NIH HEAL Initiative funds research to find scientific solutions to the opioid public health crisis. The initial $2 million award will fund the preclinical development, and, if awarded, an additional $3 million will fund the clinical development through a Phase 1 clinical study of HBI-201, an oral nitrous oxide therapeutic candidate for patients with sickle cell disease (SCD). HBI-201 is targeted for the treatment of acute pain associated with vaso-occlusive crises (VOC) in SCD. Hillhurst is collaborating on the preclinical portion of this project with Don Simone, Ph.D, and John Belcher, Ph.D., both Professors at the University of Minnesota, whose labs will test HBI-201 in mouse models of SCD pain. "With this award, the NIH HEAL Initiative enables further development of HBI-201with the objective of addressing a significant unmet need for non-opioid pain medications for patients with sickle cell disease," said Andrew Gomperts, Hillhurst's Chief Executive Officer. "We believe our novel approach of oral delivery of the analgesic nitrous oxide, approved for use by inhalation, holds great promise for these patients." About Sickle Cell Disease Sickle cell disease is a genetic disorder that is characterized by recurrent, unpredictable acute pain episodes associated with VOCs. Opioids are one of the primary means of symptomatic management of acute SCD pain, but have substantial drawbacks such as hyperalgesia, tolerance, and potential dependence. About HBI-201 Hillhurst's product, HBI-201, is an oral drug product candidate of nitrous oxide (N2O), with an administration route designed to enable the home use of N2O for patients suffering from pain associated with VOCs in SCD. The analgesic properties of N2O are well known, and N2O is an FDA-designated medical gas that is used for its analgesic, among other, properties. Other potential disease targets are conditions associated with acute pain. About Hillhurst Hillhurst is a clinical stage company focused on its proprietary GLASS™ 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 acute pain, sickle cell disease, and Parkinson's disease. This research is supported by the NIH under grant number 1UG3NS127943-01, 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 . View original content: SOURCE Hillhurst Biopharmaceuticals, Inc.

SAN DIEGO, Sept. 20, 2023 /PRNewswire/ -- 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™ 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 .