Clinical Trials & Research News

GSK, Novartis to Study Genetic Diversity for Drug Development

The pharma companies intend for the $3.6M research project to determine the impact genetic diversity in Africa has on malaria and TB drug responses and inform future drug development.

Drug Development

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By Samantha McGrail

- GSK and Novartis recently announced a research collaboration to uncover potential links between genetic diversity across regions in Africa and drug response and ultimately drug development.

The project, called Project Africa Genomic Research Approach for Diversity and Optimising Therapeutics (GRADIENT), calls on African researchers to submit strong search proposals about African genetic diversity and the treatment of malaria and tuberculosis, GSK stated.

GRADIENT will leverage $3.6 million in funding over five years and include three funding mechanisms to support the initiative, including fellowships, investigator-sponsored research, and seed-funding. 

The fellowships in academic institutions will collect and analyze data on drug responses, while hypothesis-driven research will focus on understanding genetic regional variation in drug response.

Additionally, seed-funding will allow a certain number of projects to explore new research goals, but will depend on the results from the first and second mechanisms. 

“At GSK, human genetics is a core pillar of our R&D strategy. Genetic diversity is greater in Africa than in any other continental population resulting in some African patients having varying response to treatments,” Pauline Williams, senior vice president of global health pharma at GSK, 

said in the announcement. 

“We are excited to launch Project Africa GRADIENT which aims to catalyse the best science in the continent to optimise treatment responses for malaria and tuberculosis, two infectious diseases that disproportionately affect African populations,” Williams continued. 

The South African Medical Research Council (SAMRC) will administer the project and a joint steering committee will oversee the review of submitted proposals, GSK said. Priority will be given to research that will focus on collecting data from currently under-represented regions and improving inconsistent data. 

The datasets collected through the project will be released to the public to initiate change in the way researchers understand variations between treatment efficacy and patient safety. 

“The project has the potential to improve the efficacy and tolerability of current and future medicines, starting with two of the most deadly diseases, malaria and tuberculosis,” said Lutz Hegemann, MD, chief operating officer for global health at Novartis. 

“In alignment with our ongoing efforts to strengthen scientific capabilities in lower-resource settings, this project also provides opportunities for training young African scientists in the use of advanced research methodologies and mentoring on drug development,” Hegemann continued. 

GSK urged researchers at universities, science councils, and other public research organizations across Africa to express their ‘intent to submit’ through the SAMRC website.

The pharmaceutical companies expect to announce final award recipients by the end of this year.

Currently, there are no approved vaccines capable of preventing tuberculosis in adolescents and adults, who accounted for 90 percent of people who fell ill with the disease in 2019. 

One factor in the lack of treatments for chronic diseases is genetic diversity, which greatly affects drug research and development. 

According to a 2017 study, genetic diversity in cytochrome P450 (CYP) genes may contribute to high numbers of adverse drug reactions reported in Africa. 

CYPs are enzymes containing heme as a cofactor that function as monooxygenases, which incorporate one hyroxl group into substrates in different metabolic pathways. 

In the study, researchers found that there was a greater genetic diversity in CYPs found in patients from  Africa compared with other populations, including Caucasian and Asian populations, which demonstrated tight clustering compared to the widespread distribution of the African populations.

Due to the study results, researchers concluded that Africa cannot be treated as a single entity in drug research and development.