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Oxfendazole Development Group Announces Enrollment of First Patient in Phase 2 Trial of Oxfendazole for Trichuris trichiura Infection
— Trichuris Trichiura infection, classified as a neglected tropical disease by the WHO and CDC, is caused by a parasitic whipworm and affects 800 million people worldwide —
Blue Bell, PA, October 2024 — The Oxfendazole Development Group, a not-for-profit organization developing the widely used veterinary deworming treatment oxfendazole for public health use, today announced the enrollment of the first patient in a Phase 2 clinical trial evaluating the safety and efficacy of this investigational medicine in people infected with the parasitic whipworm Trichuris trichiura. It is estimated that 800 million people worldwide have trichuriasis, the infection caused by Trichuris trichiura.(1)
This assessor-blind, randomized study has a planned enrollment of 249 participants and will compare the efficacy and safety of a single oral dose of either 400 mg or 800 mg of oxfendazole to the current standard of care, a single oral 400 mg dose of albendazole. The trial will be conducted in the Amazonian region of Peru, where there is a high prevalence of T. trichiura infection. Funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the (US) National Institutes of Health (contract HHSN272201300020I), the study is being carried out in collaboration with the Peruvian nonprofit Asociación Benéfica Prisma, the University of Iowa, the University of Virginia, and the Oxfendazole Development Group. This is the first Phase 2 study (NCT04713787) to evaluate oxfendazole in people with an active parasitic infection, following successful Phase 1 studies of single (SAD) and multiple ascending doses (MAD) of oxfendazole in healthy volunteers.
“Trichuriasis is a neglected tropical disease that can cause severe abdominal pain and other serious consequences, especially in vulnerable populations in developing parts of the world. We are committed to finding better treatments for this common infection,” said Dr. John Horton, President of the Oxfendazole Development Group. “Based on early studies, we see great promise in oxfendazole as a potential treatment option for those infected by Trichuris trichiura. We are thankful to the NIAID, the Asociación Benéfica Prisma, and study investigators in Peru and the United States for their partnership in advancing this clinical program.”
Oxfendazole has the potential to be more efficacious against human worm infections than are some currently approved medicines, due to the higher plasma levels it achieves. It is hoped that oxfendazole will provide improved treatment of several parasitic worm diseases prevalent in under-resourced areas of the world.
About Trichuris trichiura
Trichuris trichiura is the third most common roundworm of humans; it is estimated that 800 million people are infected by Trichuris trichiura globally. Infections are most commonly caused by the ingestion of infective eggs that are found in soil and are frequent in parts of the world with tropical weather and poor sanitation. Those infected can experience severe gastrointestinal issues, such as abdominal pain, diarrhea and constipation, and some children with heavy infections develop anemia, resulting in stunting of growth and physical and mental impairment. (1)
About the Oxfendazole Development Group
The Oxfendazole Development Group is a U.S.-based 501(c)(3) nonprofit organization committed to improving treatment options for some neglected tropical diseases through its development of the potentially life-changing medicine oxfendazole. Its work is supported by AstralCodexTen, Open Philanthropy and generous individual donors. For more information, visit www.oxfendazoledevelopmentgroup.org.
For further information, please reach out to us via our web site: https://oxfendazoledevelopmentgroup.org/contact-2/
Most recent publications:
Human Phase I SAD study: the results of the Phase I Single Ascending Dose (SAD) study of oxfendazole are now published. See the safety profile and pharmacokinetics of oxfendazole in healthy volunteers: publication Phase I SAD study
Human Phase I MAD study: the results of the Phase I Multiple Ascending Dose (MAD) study of oxfendazole are now published. See the safety profile and pharmacokinetics of oxfendazole following its multiple dose administration in healthy volunteers: Oxfendazole MAD study 2020
Population pharmacokinetic-pharmacodynamic model of oxfendazole in healthy adults: POP PK/PD model of oxfendazole in healthy adults, created using data from the MAD and food effect clinical studies.pop PK/PD pub
Preclinical review: Our review of the evidence of oxfendazole’s safety and efficacy against both gut and tissue dwelling parasitic worms in animals, as well as more recent safety and pharmacokinetic data, supporting oxfendazole’s investigation for use as an anthelmintic in humans. Read our review: oxfendazole expert review
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