The two public-private partnerships are intended to accelerate the development of dispersible paediatric human immunodeficiency virus medicines
Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. (Credit: C. Goldsmith from Wikimedia Commons)
Gilead Sciences has announced its partnership with Clinton Health Access Initiative (CHAI) and Penta ID network to enhance treatment and adherence rates in children with human immunodeficiency virus (HIV) in low and middle-income nations.
The two public-private partnerships are intended to accelerate the development of dispersible paediatric HIV medicines.
The first partnership with CHAI is expected to expedite the development of an investigational dispersible paediatric formulation which has emtricitabine and tenofovir alafenamide (F/TAF).
Penta’s partnership has a goal to develop investigational paediatric formulations of TAF and sofosbuvir (SOF) in order to remove bitterness.
Both collaboration deals aim to accelerate the development, regulatory approval, and commercialisation of a dispersible, fixed-dose combination treatment to treat children with HIV who weigh at least three kg and live in low- and middle-income countries. The F/TAF products from Gilead will be a part of this regimen.
According to the terms of the contract, Gilead will transfer technology for a dispersible formulation of F/TAF together with supporting pharmacokinetic (PK) data.
Penta will create the PK modelling and clinical studies for the investigational combination formulation and CHAI, with assistance from the global health agency Unitaid, will oversee the global access strategy in partnership with two generic manufacturers.
Gilead Sciences HIV clinical development vice president Jared Baeten said: “By developing medicine formulations that meet the needs of children, and by improving palatability, through these partnerships, we have the ability to potentially increase adherence rates in children.
“This collaboration, along with the recent launch of Gilead’s Pediatric Centre of Excellence in Dublin, reflects our deep commitment to the discovery and development of urgently needed treatment options for children living with HIV and other viral infections across the world.”
Additionally, Gilead is working with the Monell Chemical Senses Centre, the Translational Cell Models division of Eurofins, and CHAI to find bitter blockers for paediatric versions of the TAF and SOF drugs.
Upon confirmation of candidate bitter blockers, the partners will collaborate to ensure that these medicines advance to product development and launch if approved.