MDGH Update - June 2022

June 23, 2022

Welcome to our Q2 2022 Newsletter, highlighting the latest activities for Medicines Development for Global Health.

Mark Sullivan Joining the Panel at the Kigali Summit on Malaria and Neglected Tropical Diseases

Mark Sullivan AO, Founder and Managing Director of Medicines Development for Global Health, will attend the Kigali Summit on Malaria and Neglected Tropical Diseases in Kigali, Rwanda on 23 June 2022. The Summit, convened by RBM Partnership to End Malaria and Uniting to Combat Neglected Tropical Diseases, will take place alongside the 26th Commonwealth Heads of Government Meeting and is hosted by the Government of Rwanda. Mark will participate in a panel discussion on the morning of Thursday 23 June with the topic “Access to Innovation”.

Included among the speakers will be His Excellency Paul Kagame, President of the Republic of Rwanda, Ms Melinda French Gates, Co-Chair, Bill and Melinda Gates Foundation and Dr Tedros Ghebreyesus Adhanom, Director-General, World Health Organization.

The Kigali Summit is the culmination of efforts to follow up on the goals of Neglected Tropical Diseases elimination originally outlined in the London Declaration of 2012 and updated with targets set out in the World Health Organization’s Neglected Tropical Diseases Roadmap (2021-2030). The Summit will highlight the actions needed to end malaria and Neglected Tropical Diseases – integration, innovation, new tools, financing, and regional coordination. It will also be the venue to formally recognise the Kigali Declaration on Malaria and Neglected Tropical Diseases set by a wide range of stakeholders, through their signed commitments to the Declaration. Medicines Development for Global Health is a signatory to the Kigali Declaration.

Medicines Development for Global Health Inc Receives 501(c)(3) Public Charity Status Designation in the United States

Medicines Development for Global Health’s objective to develop and deliver medicines to those who need them requires the support of a broad community and a presence in key locations. Medicines Development for Global Health Inc, headquartered in New Jersey in association with its US-based team, was established to achieve a significant presence in the United States. The company has now been designated 501(c)(3) public charity which will facilitate discussions with supporters and like-minded organisations in the United States and in the Americas more generally.

Medicines Development for Global Health Welcomes David McGregor as a New Board Member

David McGregor, new Board Member of Medicines Development for Global Health.

Medicines Development for Global Health is pleased to announce David McGregor as new member of its Australia board of directors. David has been a partner with EY since 2000, serving clients in the media, technology, and telecommunications sectors. David was the EY Asia Pacific Technology, Media, and Telecommunications leader responsible for coordinating with global leadership to launch new initiatives and services and growing the revenue from $65m to $100m in four years. David has experience in working with high growth companies, as they raise funding, build their processes to scale, evolve their risk management practices, and has IPO experience with iCar Asia Ltd, Touchcorp Ltd and Afterpay Ltd. David has worked with EY in the United Kingdom, United States, Papua New Guinea, and Australia.

David has a BSc in Mathematics and Accountancy (University of Dundee) and is a member of the Institute of Chartered Accountants of Scotland and Australia/New Zealand.

CC-11050 Update

The development efforts in leprosy type 2 reaction with CC-11050 continue with significant progress on the preparation for further clinical development. A meeting with the United States Food and Drug Administration is being scheduled to review the clinical trial design.

In addition, the company is refining manufacture of the improved formulation of CC-11050. “The benefit of the improved formulation is that it is better absorbed in the gut, making adherence easier,” according to Lydia Iannazzo, PhD, PMP, Principal Development Manager for CC-11050. Dr. Iannazzo adds “Medicines Development for Global Health is making good progress with regards to the manufacture of a new batch of study drug, development of the clinical study design looking at the effects of CC-11050 in patients with leprosy type 2 reaction and providing continued support to the leprosy type 2 reaction and tuberculosis investigator-led studies.”

Leprosy type 2 reaction is a debilitating, but treatable, inflammatory skin manifestation of leprosy. According to the World Health Organization, more than 200,000 new cases of leprosy, in 118 countries, were detected in 2019. [Image credit: Towards Zero Leprosy (Hansen's Disease) Strategy 2021-2030, New Delhi: World Health Organization, Regional Office for South-East Asia; 2017. Licence: CC BY-NCSA 3.0 IGO]

Medicines Development for Global Health Announces Closing of the Impact Investment to Support CC-11050 Development

Medicines Development for Global Health today announced the successful closing of a AU$2.05 million (US$1.4M) impact investment financing round to support the development of CC-11050 for leprosy type 2 reaction. Fourteen Australian family trusts and private foundations participated in this initial financing round for the project.

The proceeds from the financing have been critical to the leprosy type 2 reaction clinical program, including:

- Supporting part 2 of the Phase 2 clinical trial in Nepal in leprosy type 2 reaction using the original formulation;

- Preparing for and manufacturing the improved formulation of CC‑11050;

- Preparing for interactions with the regulators;

- Modelling of dose-response data;

- Defining the overall scope of the program;

- Leveraging grant applications to global health funding bodies.

The company greatly values the wonderful contribution of the family trusts and foundations towards a better treatment for this debilitating disease.