Radioactive materials play an ever-present role in today’s world – from cancer therapies and other medical applications, to food sterilizers and household smoke detectors, to space travel, nuclear energy, and defense. If these materials are accidentally inhaled, ingested, or absorbed into the body, they can pose a serious to life-threatening health risk.
The global threat level for a nuclear or radiological disaster is arguably as high as it has ever been. Political instability and conflicts around the world have renewed fears of nuclear weapons use or damage to reactors and nuclear facilities. Nuclear power is seeing a resurgence as both nations and industry look to meet the growing energy demands of AI and society at large.
There is currently no useful treatment for people exposed to radioactive elements like plutonium, uranium, or americium – the actinides of highest concern following a nuclear reactor accident, detonation, or intentional dispersal device (a “dirty bomb”). The only FDA-approved countermeasure for such contamination – DTPA – must be administered by IV injection, and is no longer manufactured.
As an orally-dosed therapeutic, HOPO-101 is designed to be self-administered without trained medical personnel. It has been developed for disaster preparedness programs such as the U.S. Strategic National Stockpile or rescEU, and could be rapidly distributed in a mass casualty/contamination scenario. It has shown best-in-class nonclinical efficacy for both the prevention and treatment of plutonium and americium contamination.
In addition to government stockpile programs aimed at protecting civilian populations, potential military applications include planning and readiness for deployment of a tactical nuclear weapon, exposure to depleted uranium munitions and other heavy metals on the battlefield, and personnel health protection aboard nuclear-powered warships and submarines. Prospective non-government partners include utility companies that operate nuclear power plants, the nuclear medicine ecosystem, and mining, construction, and other industries whose workers may be exposed to radioactive materials.
One in three children worldwide – over 800 million – are currently living with lead (Pb) poisoning, including roughly 500,000 children aged 1-5 across the U.S. Over 1.5 million deaths per year globally are attributed to Pb exposure according to the WHO. Virtually every American born between 1966 and 1970 had Pb poisoning in childhood, both impacting early development and placing them at significantly elevated risk of cardiovascular disease and its comorbidities.
Even today, Pb is still found in paint, plumbing, car batteries, food products, household goods, and even small-engine aviation fuel, both in the U.S. and worldwide. Like many heavy metals, the toxic effects of Pb poisoning are cumulative, lifelong, and often difficult to detect. Despite an estimated $1 trillion in annual healthcare costs, an economic impact approaching 4% of GDP in Africa, and a global burden of disease larger than malaria and HIV combined, solutions for Pb poisoning have seen little innovation in the past decades.
Due to limitations in safety and efficacy, existing chelation therapies are only advised in cases of severe to critical Pb poisoning, leaving over 99% of patients without a treatment option. Children are particularly vulnerable, both from their frequent hand-to-mouth behavior around Pb-contaminated dust or dirt, and because growing bodies naturally absorb 4-5 times more Pb than adults. Childhood Pb poisoning impairs brain development, leading to decreased cognition and attention span, and difficulty with self-control and violent behavior.
The correlation between blood Pb level (BLL) and intellectual development disorder in children is firmly established. However, because existing chelation therapies are insufficiently safe and effective to justify long-term treatment of children with intermediate but not critical Pb poisoning, the beneficial effects of a safer treatment have not been well-studied. The safety profile of HOPO-101 supports a chronic dosing regimen that has the best possible chance to fully clear Pb from the body and achieve a permanent reduction in BLL in both children and adults.
Pb exposure also occurs during pregnancy, with the same health consequences. Pb is primarily deposited long-term in the bones, and when calcium from the mother is mobilized to provide nutrients in utero, Pb is also released into circulation, crossing the placental barrier and impacting development even before a child is born. If shown to be safe in reproductive toxicology studies, HOPO-101 could intercept the Pb, minimizing exposure and preventing the impact of Pb poisoning for future generations.
Virtually all heavy metals are detrimental to human health if internalized within the body. A select group are of particular concern given their presence in the food and water supply, the environment in general, and even certain medicines. These include arsenic, mercury, cadmium, gadolinium, and others.
Despite a near-ubiquitous presence in today’s environment and their well-known toxicity, there are limited treatments available for people exposed to heavy metals. For example, arsenic and cadmium are found in rice, grains, and other vegetables, mercury in fish, and gadolinium in commonly-used MRI contrast agents. Existing chelation therapies used to treat these exposures require intravenous administration, are themselves moderately toxic, and can be very harsh on the body.
In many cases, heavy metal toxicity arises from chronic, low-level exposure rather than a single poisoning event. As these metals deposit within the body over time, they become more difficult for chelating agents to access, in which case a sustained, chronic treatment is likely most effective. As an oral therapeutic with a promising safety profile, HOPO-101 has the potential to serve to serve as a short- or long-term treatment for reducing metal burden in the body.
HOPO-101 is a clinical-stage drug candidate being studied for its ability to selectively bind and promote the rapid clearance of a range of heavy metals from the body. It is uniquely designed to effectively remove harmful metals while largely sparing the essential metal ions that are crucial for maintaining normal, healthy function of the body.
HOPO-101 and all related products described on this site are STRICTLY INVESTIGATIONAL and have not been shown to be safe OR effective in any clinical trials. The statements made herein are based solely on studies carried out in animals and reflect the best good faith scientific assessment of the company and its management and scientific personnel. None of these statements have been evaluated by the FDA, and HOPO-101 is not FDA-approved for any use or indication. Additional studies are necessary before any definitive conclusions can be made.