SAN DIEGO, CA (November 7, 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 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.
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.
Hillhurst is a clinical stage company focused on its proprietary GLASSTM 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 www.hillhurstbio.com.