Development of AWZ1066S, a Small Molecule Anti-Wolbachia Candidate Macrofilaricide Drug
Status:
Not yet recruiting
Trial end date:
2022-07-31
Target enrollment:
Participant gender:
Summary
Lymphatic filariasis and onchocerciasis are a group of neglected tropical diseases caused by
the transmission of worm larvae (microfilaria) by biting insects. Once a human is infected,
the larvae mature into adult worms that release huge numbers of larvae into the lymphatics
for 5-15 years. The larvae cause tissue damage resulting in the disabling diseases of
elephantiasis (gross leg and scrotal swelling) and river blindness. These diseases affect 160
million people and are acknowledged major public health problems in the tropics. Current
treatments mainly target the larvae but not the adult worms that live for years, meaning that
repeated courses of treatment over many years are needed. These repeated courses are usually
delivered at population level in the form of mass drug administration programmes.
For the adult worms to be able to grow, reproduce and infect more humans they are dependent
on a bacterium which lives inside them. This bacterium (Wolbachia) is not naturally found in
humans. Some drugs are able to target Wolbachia, however they are unsuitable for mass drug
administration programmes because they have to be given for 4-6 weeks and cannot be used in
children or pregnant women.
AWZ1066S is a novel drug developed in Liverpool that has been shown in experimental models to
target Wolbachia and indirectly kill the adult parasitic worms after a 7 day course. After
extensive safety testing in animals we are conducting a Phase 1, first in human study, to
assess the safety, tolerability and pharmacokinetics of ascending single and multiple oral
doses of AWZ1066S in healthy volunteers. The study is a single centre study, will last
approximately 1 year and will take place in a dedicated Phase 1 trial unit. Depending on
which group they are enrolled into, participants will take either one dose, two doses or
seven doses and their involvement will last between 38 and 45 days. Participants will be
closely monitored for adverse effects.
Phase:
Phase 1
Details
Lead Sponsor:
Liverpool School of Tropical Medicine
Collaborators:
Covance Eisai Limited Liverpool University Hospitals NHS Foundation Trust Subiaco Associates Limited Sylexis Limited