TITUSVILLE, N.J., March 30, 2017 – Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced today the discontinuation of the development of an orally bioavailable formulation of flubendazole, which was being investigated as a treatment for onchocerciasis. The decision was made because data from studies in animals raised safety concerns at high doses or with prolonged exposure to the oral formulation.
“Despite our decision to not proceed with clinical trials of the oral flubendazole formulation, we are proud that Johnson & Johnson was able to fulfill its commitment in the 2012 London Declaration on Neglected Tropical Diseases to pursue the development of flubendazole for onchocerciasis,” said Wim Parys, Head of Research & Development, Global Public Health, Johnson & Johnson. “We will continue to support ongoing efforts to find improved treatment and diagnostics solutions by sharing preclinical data with partners so that others can leverage this research.”
The current recommended treatment for onchocerciasis, also known as river blindness, is ivermectin. This treatment kills only the larvae, which successfully alleviates the cutaneous symptoms of onchocerciasis, but it does not kill adult worms. Following a period of temporary sterility, the adult worms may resume production of larvae, which cause symptoms to return, requiring repeated treatment every 6-12 months.
Addressing the limitations of the current treatment regimen was the catalyst for exploring other potential treatment options targeting the adult worms, such as flubendazole. Following the demonstration of 100% efficacy against adult worms in animal models when given subcutaneously, Janssen scientists focused on developing an oral formulation of flubendazole and assessing its potential to achieve similar efficacy. Janssen tested several oral formulations of the compound and evaluated its final formulation for toxicological, pharmacokinetic and efficacy properties in several animal models. After careful analysis of a robust preclinical data package, Janssen determined that no oral or parenteral regimen could be selected that would provide efficacy against onchocerciasis in humans at safe exposure levels.
Onchocerciasis is a neglected tropical disease (NTD) caused by the parasitic worm species Onchocerca volvulus, which spreads through bites from infected black flies. The presence of larvae in the skin causes several symptoms, including intolerable itching. Larvae can migrate to the eye and cause decreased vision and blindness. Adult worms live in nodules in the skin, can survive for 10-15 years and produce thousands of larvae per day.
Flubendazole, originally discovered and developed by researcher Dr. Paul Janssen and his team, was first approved for human use in 1980 to treat soil transmitted helminths, also known as intestinal worms. Unlike the formulation studied for the treatment of onchocerciasis, the formulations used to treat soil transmitted helminths are not systemically absorbed and thus remain largely in the gut and are generally safe.
For more information on Johnson & Johnson’s work in eradicating NTDs, visit www.janssen.com/global-public-health/neglected-tropical-diseases.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at Twitter.com/JanssenGlobal.
About Johnson & Johnson
Caring for the world one person at a time inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people. Our approximately 126,400 employees at more than 230 Johnson & Johnson operating companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
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