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Oxfendazole Development Group receives ACX Grant through the Center for Effective Altruism

The Oxfendazole Development Group (ODG), the nonprofit company focused entirely on the development of the veterinary deworming medicine oxfendazole for use against parasitic worms in humans, announces the receipt of funding from the ACX Grants Program through the Centre for Effective Altruism to further its oxfendazole development program.

Oxfendazole, an orally bioavailable small molecule medicine, has been used for decades as a deworming treatment in animals, including those raised for human foodstuffs (dairy products or meat). Data from oxfendazole’s effectiveness in animals suggest that oxfendazole may have greater effect against certain parasitic worms such as Trichuris species that are poorly treated by medicines presently available for human use.

Parasitic worms called soil transmitted helminths (STH) are a major health problem, infecting 24% of the world’s population, mostly in economically disadvantaged regions of the world. To mitigate against the adverse sequelae of these parasitic infections, including anemia, low birth weight, stunted growth, and cognitive impairment, deworming efforts are the focus of several major charitable groups, and effective altruism organizations such as GiveWell show that charitable contributions to deworming programs are among the most effective uses of charitable donations. However, the currently used deworming medicine albendazole cures only about 35% of Trichuris trichiura infected persons, leaving the remaining 65% still wormy, impelling the work to develop oxfendazole for human use.

Through a collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, oxfendazole has successfully progressed through two Phase I studies in healthy human subjects, single ascending and multiple ascending dose studies. Presently, the first study of oxfendazole in human patients infected with the parasitic worm Trichuris trichiura is nearing initiation in Peru.

The Oxfendazole Development Group has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the investigation of oxfendazole for the treatment of trichuriasis, a designation made in recognition of the seriousness of infection with the parasitic worm Trichuris trichiura, as well as the unmet medical need arising from the poor efficacy of currently approved treatments for this parasite. The Oxfendazole Development Group is pleased to have received this opportunity to work more closely with the FDA to accelerate oxfendazole’s development for human use, an effort furthered by the present funding by the ACX Grants Program.

 

The FDA grants Fast Track Designation to ODG’s investigation of oxfendazole for the treatment of trichuriasis

The Oxfendazole Development Group has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the investigation of oxfendazole for the treatment of trichuriasis.  This designation is made in recognition of the seriousness of infection with the parasitic worm Trichuris trichiura,1 as well as the unmet medical need arising from the poor efficacy of currently approved treatments for this parasite.2

Presently approved as a deworming medicine in animals, oxfendazole is being investigated as an improved deworming medicine for some human parasitic worms. Fast Track Designation conveys several benefits to our development program including more frequent meetings with the FDA, more frequent written communication from the FDA, and eligibility for Rolling Review, Accelerated Approval and Priority Review, if relevant criteria are met.

The Oxfendazole Development Group is pleased to have received this opportunity to work more closely with the FDA to accelerate oxfendazole’s development for human use.

  1. Stephenson L, Holland C, Cooper EJP. The public health significance of Trichuris trichiura. 2000;121(S1):S73-S95.
  2. Keiser J, Utzinger J. Efficacy of current drugs against soil-transmitted helminth infections: systematic review and meta-analysis. JAMA. 2008;299(16):1937-1948.

New 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