Phastar, a prominent global biometrics contract research organization (CRO), announced its commitment to providing pro bono assistance to Medicines Development for Global Health (MDGH), a non-profit organization dedicated to developing medicines for neglected diseases primarily affecting populations in low- and middle-income countries.
As part of the Phastar Cares initiative, MDGH has been granted complimentary access to Phastar's team of biometrics experts, who are actively contributing to two substantial double-blind Phase IIIb clinical studies taking place in the Democratic Republic of Congo and Cote d’Ivoire. One trial focuses on assessing the safety of moxidectin, while the other investigates repeat single dosing in comparison to ivermectin in individuals residing in regions endemic for onchocerciasis (river blindness).
Onchocerciasis is presently managed through periodic community-directed preventive treatment. Moxidectin has demonstrated significant superiority to the current treatment in both Phase II and Phase III efficacy clinical trials, with similar safety profiles for both medications.
Extensive mathematical modeling studies have examined the impact of moxidectin on eliminating onchocerciasis transmission. The data suggests that annual or biannual administration of moxidectin, as an alternative to the current standard of care, could substantially expedite transmission elimination.
In 2018, MDGH obtained FDA approval for moxidectin in a single 8 milligram dose for treating onchocerciasis in individuals aged 12 and older, with ongoing efforts to extend the indication to children as young as 4. The current double-blind Phase IIIb study, encompassing over 12,000 participants, represents a critical stride towards establishing moxidectin as a recommended intervention in line with World Health Organization guidelines.
The recent achievement of full participant recruitment has necessitated a comprehensive review of the statistical analysis plan and associated data management documents. Through the Phastar Cares pro bono initiative, Phastar's biostatistics experts meticulously assessed the statistical analysis plan vis-à-vis the protocol's primary and secondary objectives. They also developed and outlined the planned outputs to ensure alignment with both the protocol's objectives and MDGH's overarching goals.
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