HOPO 14-1

BERKELEY, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) -- HOPO Therapeutics, Inc. announced today that it has been awarded a contract valued at up to $226 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. The funds will be used to advance development of the drug candidate HOPO-101 through registrational studies as a medical countermeasure against radiological threats, including planned submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The initial award of approximately $9.4 million will fund toxicology and pharmacology studies, manufacturing activities, and nonclinical research in other types of heavy metal poisoning, with approximately $216 million in additional funding available for later-stage development upon agreement between BARDA and HOPO. The ongoing Phase 1 clinical study of HOPO-101 (NCT05628961), as well as earlier nonclinical work, has been funded by the National Institute of Allergy and Infectious Diseases. There are no approved oral therapies to treat individuals exposed to radioactive heavy metals like plutonium, americium, and curium. In the event of a radiological or nuclear disaster, treatment with a decorporation agent – a drug designed to bind and accelerate the clearance of heavy metals from the body – is the only practical means to mitigate the risk of radiation poisoning. HOPO Therapeutics is developing decorporation agents that can be taken orally, with the aim of providing rapid access to treatment for an exposed population. This BARDA funding will also be used to study HOPO-101 as a possible treatment for lead poisoning. As recently highlighted by several leading global health organizations including the U.S. Agency for International Development (USAID), lead poisoning kills an estimated 1.5 million people each year, more than malaria and HIV combined. Most of these deaths, and the over 800 million children currently suffering from lead poisoning, are in low- and middle-income communities. “We are thrilled to partner with BARDA on the development of a new oral decorporation agent for radiological threat preparedness,” said Dr. Julian Rees, HOPO’s Chief Executive Officer and co-founder. “We believe that HOPO-101 can fill an important gap in the world’s ability to respond to a nuclear or radiological disaster, a scenario made ever more likely by ongoing conflicts around the world, and that it could also help to address one of the most significant unmet needs in global health. Nonclinical studies indicate that HOPO-101 would be a substantial improvement over the existing standard of care, and we are delighted to have BARDA’s support in exploring its dual-use capability as both a medical countermeasure and a potential treatment for lead poisoning in adults and children.” Funding for this award was received under contract through BARDA’s Broad Agency Announcement. This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50124C00062. About HOPO Therapeutics HOPO Therapeutics is a privately-held, clinical-stage pharmaceutical company developing treatments for heavy metal poisoning and pioneering novel methods for directed radioisotope delivery. Leveraging world-class expertise in the chemistry and biochemistry of heavy metals and technology licensed from Lawrence Berkeley National Laboratory, HOPO’s mission is to safeguard all people throughout the world from the harmful effects of heavy metal contamination while utilizing the power of metals in medicine to cure disease and improve lives. For more information, please visit www.hopotx.com.

HOPO Therapeutics scored a government contract for up to $226 million to develop an oral countermeasure against radiological threats and heavy metal poisoning. The funding from the Biomedical Advanced Research and Development Authority (BARDA) will go toward investigating HOPO-101 in registrational studies, including a planned submission to the FDA, as a treatment for radiological threats as well as studies in other heavy metals like lead. According to the company, HOPO-101 would be the first oral treatment for people exposed to radioactive heavy metals like plutonium, americium and curium. In the event of a radiological or nuclear disaster, the company said treatment with a drug like HOPO-101 is the only “practical means to mitigate the risk of radiation poisoning.” The drug works as a chelating agent; it binds to heavy metals and then can be excreted by the body. The current standard of care for radioactive poisoning is a slow IV infusion treatment. “The job of the chelating agent is really to vastly accelerate how quickly the body will clear these heavy metals,” HOPO CEO and co-founder Julian Rees said in an interview. In a disaster scenario, the standard of care is “extremely burdensome,” he noted. While HOPO-101 is already in a Phase 1 trial in healthy volunteers that is separately funded by the National Institute of Allergy and Infectious Diseases, BARDA’s funding is expected to get the drug through early-stage and pivotal studies in heavy metal poisoning. The pivotal studies will be done in animal models instead of humans, though HOPO will also go through the pharmacology and safety studies in healthy volunteers. The initial award is $9.4 million. “The specific targets of what we will look at and what we believe we can address — this is something that that initial tranche of funding is designed to help us tackle — is to really understand what is the full scope of capability of this product, particularly on the non-radioactive side,” Rees told Endpoints News . That will include investigating whether the pill could also work in poisonings with lead, mercury, cadmium and arsenic, all of which are heavy metals that are already in the environment. “Many of them don’t have good treatments, so that’s part of what that initial award is designed to address,” Rees added.