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Case Study: Analytical Development for MDGH

In 2016, the not-for-profit Australian biopharmaceutical company Medicines Development for Global Health (MDGH) came to Alcami to initiate work on moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). The project utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical New Drug Application (NDA) filing timelines. Now, the two companies are exploring new opportunities to help eliminate neglected tropical diseases that affect over 2 billion of the world’s most disadvantaged people.

Client Profile

Medicines Development for Global Health (MDGH) is an independent not-for-profit biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. Based in Melbourne, Australia, the company uses all funds in excess of running costs to develop medicines and vaccines that may have limited commercial opportunity, but address important unmet medical needs.

Product Background

Moxidectin is a new medicine developed for the treatment of river blindness (onchocerciasis), an eye and skin disease caused by larvae (microfilariae) of the parasitic worm Onchocerca volvulus. The disease is endemic in sub-Saharan Africa and 16 million people are infected. The larvae cause significant morbidity, including severe itching, skin conditions, and eye damage, resulting in impaired vision and eventually permanent blindness in some sufferers. Clinical studies revealed a statistically significant superiority of moxidectin over the current standard of care, ivermectin, in controlling and eliminating microfilariae from the skin. Moxidectin is also being evaluated as a potential treatment for scabies, Strongyloides, soil-transmitted parasitic worms, and lymphatic filariasis, diseases that affect approximately 1.5 billion people.

The Relationship with Alcami

MDGH was referred to Alcami’s Wilmington, North Carolina analytical testing technology center in September 2016. Alcami initiated work on the moxidectin project the following February, developing and validating a dissolution method. The project evolved to incorporate analytical support for drug product process improvement, additional analytical support including inductively coupled plasma mass spectrometry (ICP-MS) testing, and a solubility study– all at an accelerated pace – to meet MDGH’s filing timelines for its New Drug Application (NDA). Close collaboration between the Alcami and MDGH teams led to this project’s successful on-time completion. Experts from both organizations met daily to discuss and track progress.

Challenges and Solutions

The development of a discriminating dissolution method was necessary for moxidectin to receive FDA approval, and it proved to be this collaboration’s biggest challenge. For three months, Alcami’s analytical team worked to develop a method that would discriminate for particle size, disintegrant, tablet hardness, and other key tablet attributes. The very low strength of the active pharmaceutical ingredient (API) in the tablet and the lack of ionizable functional groups on the molecule to assist aqueous solubility created unique obstacles. For these reasons, the Alcami team endeavored to find a surfactant that would aid solubility, but not cause rapid release of the API. Multiple configurations and many concentrations of four different surfactants were run, and a non-ionic surfactant was ultimately chosen to achieve a discriminating profile. Filter adsorption, API sticking, and internal standard development were among the other method issues Alcami resolved. Over 30 samples were analyzed to validate the method and prove its discriminating ability.

Where Are They Now

MDGH received FDA approval for moxidectin 8 mg per oral for the treatment of river blindness in patients aged 12 years and older on June 13, 2018, and was also awarded a priority review voucher (PRV) – an item which entitles its holder to either faster review of a subsequent new drug application (NDA), or that can be sold to further fund research and development. Alcami and MDGH look forward to exploring future collaborative opportunities, using their combined expertise to help eliminate neglected tropical diseases which affect over 2 billion of the world’s most disadvantaged people.