SAN DIEGO, CA (March 25, 2021) Hillhurst Biopharmaceuticals, Inc., a biopharmaceutical company focused on developing therapies enabling the chronic therapeutic use of low dose carbon monoxide (CO), today announced the award of a Phase 1 Small Business Technology Transfer (STTR) grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of approximately $300,000 to fund further pre-clinical development of Hillhurst’s lead candidate, HBI-002, an oral therapeutic for the treatment of ulcerative colitis, among other indications. This novel technology targets a protective cellular metabolic pathway (heme oxygenase) known to modulate inflammatory processes and cell death programs, and to promote tissue repair. Other formulations of low dose carbon monoxide have been demonstrated to mitigate ulcerative colitis in preclinical studies, though these other formulations are neither commercially nor clinically viable. Hillhurst is collaborating on this pre-clinical project with Leo Otterbein, Ph.D., staff scientist at Beth Israel Deaconess Medical Center and Professor of Surgery at Harvard Medical School, whose lab will test HBI-002 in in vivo ulcerative colitis models in mice. The Company anticipates initiating a Phase 1 clinical study in healthy volunteers within the next year.

“With this award, Hillhurst will explore the therapeutic potential of low dose carbon monoxide delivered with HBI-002 to address this important medical need in ulcerative colitis,” said Andrew Gomperts, Hillhurst’s Chief Executive Officer. “Hillhurst is grateful to the NIDDK for this competitive grant. We believe the promise of our novel approach of oral delivery of low dose carbon monoxide is further validated by this award.”

Ulcerative Colitis (UC) is a chronic inflammatory disorder of the large intestine that is estimated to impact over half a million adults in the United States, leading to morbidity, heightened risk of cancer, and mortality. Existing drugs show variable efficacy and do not halt disease progression, and some are associated with increased risk of infection and cancer. Currently there are no effective means by which to interfere and dampen inflammation and re-establish immune tolerance, which is a major therapeutic goal for treating UC. Thus, there is a significant unmet clinical need for new therapies.

Dr. Otterbein is a paid consultant for and has ownership interest in the Company.

The content in this release is the sole responsibility of Hillhurst and does not necessarily represent the official views or imply endorsement of the National Institutes of Health.

About HBI-002
Hillhurst’s lead product, HBI-002, is an IND-ready oral drug product of low dose carbon monoxide, enabling acute and chronic use within and outside of the hospital setting for patients suffering from conditions associated with inflammation and cell death. A Phase 1 clinical study with HBI-002 is planned within the next year.

About Hillhurst
Hillhurst is a near-clinical stage company focused on hematologic and inflammatory disorders. It has generated compelling preclinical efficacy data with its lead product HBI-002. Hillhurst has developed a novel platform that enables oral delivery of low dose carbon monoxide (CO), which mimics the protection afforded by the cytoprotective heme oxygenase enzyme.

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

Media Contact:   Andrew Gomperts   President and CEO   hillhurstpress@hillhurstbio.com