Kenya Medical Research Institute

AI in precision medicine can enhance healthcare outcomes in Africa by tailoring treatments to individual patient characteristics, but ethical challenges like data privacy, algorithmic bias, and informed consent must be addressed to ensure trust and equitable access.

The ACHIEVE study, funded by CEPI with $10.3M, aims to estimate chikungunya cases in Kenya and Tanzania, starting spring 2025. Led by Oxford's Centre for Tropical Medicine, it seeks to improve understanding of the disease's burden and inform vaccine development and deployment strategies.

KEMRI researchers urge Kenya's Pharmacy and Poisons Board to approve Cabotegravir and Lenacapavir, injectable drugs with high efficacy in preventing HIV. Cabotegravir, requiring injections every eight weeks, and Lenacapavir, every six months, have shown significant prevention rates, approved by the FDA and EMA. Despite Cabotegravir's registration in Kenya, Lenacapavir's application is pending, and both drugs are costly, posing accessibility challenges. KEMRI appeals for faster approvals to reduce HIV infections in Kenya.

Pharmaceutical companies conduct most clinical trials in countries where they plan to market products, often neglecting low and middle-income countries (LMICs), particularly in sub-Saharan Africa. This exclusion limits access to life-saving treatments and therapies for patients in these regions. The Access to Medicine Foundation report highlights a gap in product registration in Africa, with 43% of innovative products approved in the past five years not registered in any African countries. The report calls for pharmaceutical companies to prioritize equitable access and work with local partners to build research capabilities in LMICs.

The Institute for Resilient Health Systems (IRHS) was launched at LSTM’s 125th Anniversary Scientific Symposium to create resilient health systems worldwide by building a global network of researchers. IRHS aims to support health systems in anticipating and coping with uncertainties, focusing on factors that enable systems to prepare and respond to shocks while maintaining function. It will initially operate at LSTM, MLW, KEMRI, and CeSHHAR, with plans for phased geographic expansion.

Tonix Pharmaceuticals submitted an NDA to the FDA for TNX-102 SL for fibromyalgia, based on two Phase 3 studies. The FDA granted Fast Track Designation in July 2024. Tonix expects an FDA decision on NDA acceptance in December 2024 and a PDUFA date in 2025. If approved, TNX-102 SL would be the first new drug for fibromyalgia in over 15 years. Additionally, Tonix presented data on a potential mpox vaccine, TNX-801, and secured a DoD contract for $34 million to develop a broad-spectrum antiviral drug.

Tonix Pharmaceuticals submitted an NDA to FDA for TNX-102 SL for fibromyalgia, based on two successful Phase 3 studies. The drug received Fast Track Designation in July 2024, with an FDA decision expected in December 2024. If approved in 2025, it would be the first new fibromyalgia drug in over 15 years. The company reported Q3 2024 financial results with $28.2 million in cash, $2.8 million in product revenue, and a net loss of $14.2 million. Tonix also secured a DoD contract worth up to $34 million for antiviral drug development.

KEMRI researchers urge Kenya's Pharmacy and Poisons Board to approve Cabotegravir and Lenacapavir, injectable drugs with high HIV prevention efficacy. Cabotegravir, requiring injections every 8 weeks, and Lenacapavir, every 6 months, have shown remarkable prevention rates but face high costs and regulatory delays.

Tonix Pharmaceuticals collaborates with Kenya Medical Research Institute to test TNX-801 vaccine for mpox safety, tolerability, and immunogenicity in a Phase I clinical study.