Infectious diseases

Progress

Treating schistosomiasis in children under six

Around 10% of the approximately 220 million people worldwide with schistosomiasis are younger than six years old. These children cannot be treated with praziquantel, the standard therapy for the parasitic disease. This is something we intend to change. Since July 2012, we have been working with partners from industry and research institutes on the development of a pediatric formulation of praziquantel. As part of these efforts, in 2015 we successfully completed two Phase I bioavailability studies in healthy subjects in South Africa, as well as a taste study in children in Tanzania.

In 2016, the Pediatric Praziquantel Consortium initiated a Phase II study in Ivory Coast; the trial aims to assess the efficacy and safety of two different formulations for orodispersible tablets in schistosomiasis-infected children under the age of six. At the same time, we are preparing the Phase III study.

In recognition of all these efforts, the consortium was awarded a prestigious research grant from the Japanese Global Health Innovation Technology Fund in both 2015 and 2016, which followed the one awarded in 2014.

Accurately diagnosing malaria

In many African countries such as Zimbabwe and Uganda, the rate of co-infection with HIV and malaria is very high. In HIV-infected patients who develop a fever, it is therefore very important to establish whether they also have malaria. Current systems, however, are not accurate enough, which often leads to other febrile illnesses being wrongly diagnosed as malaria.

In 2015, we started expanding our Muse^® Auto CD4/CD4% diagnostic kit, which until then had been used for monitoring the treatment of HIV patients in Sub-Saharan Africa and other developing regions. With this system, medical professionals can obtain information on the course of an HIV infection. The advantage is that blood samples no longer need be sent to clinics in the cities. The new Muse^® malaria diagnostic kit can measure the presence and type of malaria parasite as well as a co-infection with HIV. The system is expected to be launched in 2019.

Promising antimalarial compound

In developing antimalarial compounds, we are collaborating with Medicines for Malaria Ventures (MMV). Since current treatments are increasingly succumbing to drug resistance, MMV is focusing on the development of new compounds.

In March 2015, we obtained the rights to an investigational antimalarial compound from MMV. The compound potentially represents a novel mechanism of action and is intended to be developed for both the treatment and prevention of malaria in young children. This R&D project completed its preclinical phase in 2016 and is preparing for Phase I to start in 2017.

Building capacities in health systems

In addition to financing fellowships in Zimbabwe and Kenya, in 2016 we launched a partnership with the University of Namibia that is sponsoring two PhD fellows in their research. In support of Governmental Malaria Control Programs, these scientists are studying the spread of an extremely widespread malaria pathogen found in Namibia, Botswana and Zambia and are also working to characterize parasite subtypes in the populations in these African countries.

Moreover, we also co-sponsor several international fellowship programs for postdoctoral researchers from developing and emerging countries. In addition to receiving training on clinical aspects including clinical trial practices and clinical management, these research fellows are given the opportunity to work for a period of up to 24 months in leading pharmaceutical companies (including our company). On returning to their home countries and academic institutions, they then have the key resources needed to lead and implement their research in line with international regulatory requirements and standards.

Deepening the dialogue on malaria and schistosomiasis

In 2015 and 2016, we stepped up the dialogue on infectious diseases with important stakeholders and experts. Among other achievements, we gained a new partner for the Pediatric Praziquantel Consortium, namely the Schistosomiasis Control Initiative (SCI), which is part of Imperial College London in the United Kingdom. SCI works closely with health ministries in African countries and supports the consortium in efforts such as developing the access and delivery plan for our new pediatric drug for children under six.

Furthermore, in November 2015, we joined forces with the University of Cape Town (South Africa) to co-develop R&D platforms for identifying new lead programs for the treatment of malaria, with the potential for expansion to other tropical diseases. As part of the collaboration, research has been conducted using Merck KGaA, Darmstadt, Germany’s compound library.

Moreover, we took part in the following international conferences and events:

• Workshop entitled “Schistosomiasis in women and its impact on HIV” in Magaliesburg, South Africa in January 2015
• The International Schistosomiasis Conference on schistosomiasis elimination strategies in San Salvador, Brazil in August 2015
• The 9^th European Congress on Tropical Medicine and International Health held in Basel, Switzerland in September 2015
• The American Society of Tropical Medicine and Hygiene (ASTMH) conferences in 2015 and 2016 in the United States
• The Better Medicines for Children Conference hosted by the European Medicines Agency (EMA) in London (UK) in October 2016
• The African Society for Laboratory Medicines (ASLM) conference held in Cape Town, South Africa in December 2016