As part of the Phastar Cares scheme, MDGH has pro bono access to the company’s biometrics experts as it conducts two large double-blind phase 3b clinical studies at sites in the Democratic Republic of Congo and Cote d’Ivoire. One trial is evaluating the safety of moxidectin and the second is evaluating repeat single dosing compared with ivermectin in individuals living in onchocerciasis (river blindness) endemic areas.
Graham Clark, CEO at Phastar, said: “We have the expertise and the resources to make a meaningful difference and to deliver on our mission to improve human health. As a B Corp organization, we strive to be a force for good, and one of our strategic objectives is to lead the CRO industry in corporate social responsibility.
“The Phastar Cares Scheme, which offers free access to our statisticians, data scientists, data managers, and programmers, is an important part of that commitment. We are proud to be in a position to help MDGH on their mission to eradicate onchocerciasis.”
Onchocerciasis is currently controlled through annual or biannual preventive community-directed treatment. Moxidectin has been shown to be significantly superior to the current treatment in phase 2 and phase 3 efficacy clinical trials, with both medicines having similar safety profiles.
Impact of moxidectin
The impact of moxidectin on onchocerciasis transmission elimination has been extensively studied in mathematical models and the data suggests annual or biannual administration of moxidectin, as an alternative to the current standard of care, could significantly accelerate transmission elimination.
MDGH received FDA approval for moxidectin in 2018 as a single 8mg dose for the treatment of onchocerciasis in people 12 years of age and older with efforts underway to expand the indication to children as young as 4 years.
The current double-blind phase 3b study of more than 12,000 participants is an important step in progressing moxidectin for onchocerciasis to achieve World Health Organization guideline inclusion.
Once recruitment was completed, a substantial review of the statistical analysis plan along with associated documents for data management, was needed.
Phastar’s biostatistics experts, through the Phastar Cares pro bono scheme, reviewed the statistical analysis plan against the protocol's primary and secondary objectives and developed and drafted planned outputs to ensure they meet the stated objectives of the protocol and MDGH’s objectives.
Medicines for neglected diseases
Mark Sullivan, founder and managing director of MDGH, said: “Developing medicines for neglected diseases for disadvantaged communities is an expensive and complicated process. The support of the Phastar Cares scheme is such a wonderful way for us to access Phastar’s expertise and we greatly appreciate their extraordinarily generous and helpful contribution.
“More than 200 million people live in areas of Africa which are endemic for onchocerciasis, a serious, debilitating and stigmatizing neglected infectious disease. Moxidectin is the first new medicine registered for the treatment of onchocerciasis in more than 20 years. The data resulting from MDGH’s current study is critical to enabling the World Health Organization (WHO) to decide on moxidectin’s role in the treatment guidelines on which many countries rely.”
Phastar Cares is a pro bono scheme allowing charities to access Phastar’s biometrics experts at no cost.