Medicines Development for Global Health Inc

MDGH exists to accelerate elimination of NTDs wherever possible.

Our objective is to have a significant impact on the treatment of these diseases. Consistent with the vision of the organization, we will achieve this by developing a portfolio of medicines that address important unmet medical needs in treating neglected diseases, including novel and generic medicines (repurposing high-pedigree medicines for new indications or the application of formulation expertise to pediatric formulations and/or combination therapies that results in improved patient outcomes).

Neglected diseases are endemic in low- and middle-income countries, and they are devastating. They affect not just the individual, but also the communities and countries in which the diseases are prevalent. Many people outside of the global public health community are unaware of just how devastating many of these diseases are and how difficult it is to get effective, available, and affordable medicines to those who are suffering and at risk. At MDGH, we are working to amend this issue.

The health needs of communities’ influence – but are not the sole driver of – research and development leading to new medicines. The process of developing medicines is long, high-risk, and expensive, and is predicated on a return of investment through sales of a successfully developed product. So, what happens when diseases affect those who cannot afford to pay? Research is constrained, the more costly development stage is moribund, and the supply of novel medicines dries up.

At MDGH, we choose not to neglect those who cannot afford to pay. We believe that developing new and improved treatments for neglected diseases will make a lasting difference on the health, social, educational, and economic well-being of affected communities.

MDGH achieved US FDA approval for its medicine, moxidectin, as a treatment for river blindness and have now made great strides toward implementing community-directed treatment (direct distribution of medicine to endemic communities by local community distributor volunteers). In addition to river blindness, MDGH is evaluating moxidectin as a potential new treatment option for lymphatic filariasis as well as for scabies infestations.

MDGH recently licensed another medicine, dovramilast, from Amgen. We will be evaluating the potential for dovramilast as a potential new treatment option for people suffering from leprosy Type 2 reaction. We will also be evaluating dovramilast as an adjunct to multi-drug therapies for TB.

With these two medicines, MDGH is targeting seven different diseases that collectively have a global prevalence of nearly two billion cases.

At MDGH, we believe every person, regardless of who they are and where they live, should have access to the best medicines.

NTDs have a significant impact on the lives of one in every five people on the planet.

The WHO’s 2021–2030 road map for NTDs is an ambitious manifesto whose goal is the elimination of NTDs and ending tuberculosis as a public health problem. Our efforts at MDGH align with parts of almost all of WHO’s Sustainable Development Goals (SDGs,) and are central to SDG 3:
- ‘Ensure healthy lives and promote well-being for all at all ages’ and specifically targets SDG 3.3:
- ‘By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases.’

Going beyond diseases

The long-term impact of our efforts goes far beyond improving health within a community. Studies consistently show that improving the health of a community, in turn, results in improvements in the social, educational, and economic well-being of that community.

What MDGH does

MDGH applies its expertise in regulatory science to the development and delivery of new and improved prescription medicines.

The MDGH development model is resource-efficient and cost-effective and is intended to reduce the time and expense of bringing medicines through development to delivery into affected communities. It is built on identifying and integrating the necessary expertise from each part of the development pathway at the time that expertise is needed. We undertake product development under the strictest of global regulatory standards to achieve and maintain regulatory approval, and we work with partners to ensure the delivery of medicines to those who need them most.

Like a traditional pharmaceutical company, MDGH develops medicines through the various phases of clinical trials with the ultimate goal of achieving stringent regulatory authority approval (from the US Food & Drug Administration or the EU European Medicines Agency). However, in our model, where we combine the strongest elements of product development partnerships and the traditional biopharmaceutical industry, MDGH can focus on developing and delivering medicines to those most in need while maintaining independence as a not-for-profit organization.

While we engage academia and industry partners in our work, we do not require a pharmaceutical company partner because we can undertake all phases of clinical trial product development in-house. Additionally, because we have no sales force or distribution network, we engage with external partners to achieve access for our approved medicines (rather than delivering our medicines directly to affected communities).

Project Team structure and philosophy

The Project Team sits at the heart of the execution of MDGH’s development programs, in accordance with pharmaceutical industry standards. Each project has an appointed Project Leader and, if warranted by the stage and complexity of the program, a Project Manager. Project Leadership within each project team is responsible for setting the strategy and ensuring the execution of the agreed workplan in accordance with the associated working practice.

Essential functions and their roles

In addition to the Development leads, the following functions are also considered critical to the efficient operations and are staffed by MDGH personnel:

• Quality Control
• Manufacturing
• Regulatory Affairs
• Clinical Operations
• Corporate Operations

Additional support for workplan executions is derived from external partners and collaborators, supervised by the Project Leaders.

• River Blindness
- 2018, received US FDA approval for moxidectin for river blindness for people aged 12 years and older. Now generating the additional data required to carry out community-directed treatment in endemic areas, through targeting WHO endorsement for use in river blindness treatment programs.
- Working on local regulatory approval in African countries and the evaluation of pilot implementation studies in several river blindness-endemic countries.
- Pediatric formulation studies are underway to determine the best format for use in children under four years of age and others unable to swallow tablets. Pediatric sNDA to be filed by Q4 2024
- Cutting-edge moxidectin pharmacokinetic modelling program in breastfeeding and pregnant women, to better estimate the impact of treating this group with moxidectin.
- Conducting a modelling study to determine how moxidectin could reduce time to elimination of this disease.

• Lymphatic Filariasis
- Current participating in comparative Phase 2/3 clinical trials in Côte d’Ivoire to evaluate the safety and efficacy of moxidectin in combination with albendazole and diethylcarbamazine (DEC) versus the current standard of care of albendazole, ivermectin and DEC.
- Collaborating with the Death to Onchocerciasis and Lymphatic Filariasis (DOLF) project run by Washington University, St. Louis, USA, with the Regional Hospital of Agboville (Côte d'Ivoire) and Case Western Reserve University (USA).

• Scabies
- Moxidectin was recently evaluated as a potential treatment for scabies in a Phase 2 dose-finding clinical trial sponsored by MDGH in France, Austria, and Australia. Data from this study will be used to inform dose and design of the next clinical study, a Phase 2b dose confirmatory study. The multinational Phase 2b trial began in 2023 in Latin America and North America.

• Leprosy
- We are evaluating an improved treatment for leprosy Type 2 reaction, an immune-mediated and severe complication of leprosy, which can affect people with active leprosy infection, as well as those who have been effectively cured with multidrug therapy, even many years later. Leprosy Mission Nepal received approval to commence Step 2 of investigational safety and efficacy study in patients with leprosy Type 2 reaction.

• TB
MDGH are supporting investigatory efforts on a more effective treatment for one of the leading causes of infectious deaths worldwide. The investigation of the potential for dovramilast in the treatment of tuberculosis in a Phase 2b clinical trial is sponsored by the Aurum Institute, having completed proof of concept in a Phase 2a study sponsored by the Aurum Institute and funded by the Bill and Melinda Gates Foundation.

• Strongyloidiasis
- We are collaborating on clinical trials for a new treatment for this sometimes-fatal common infection.

• Soil-transmitted Helminths
We are evaluating a new treatment for this common infection that affects the world’s poorest communities.