GSK stops development of brecanavir
On 18 December, GlaxoSmithKline (GSK) announced that, due to insurmountable issues regarding formulation, the clinical development programme for the investigational HIV protease inhibitor brecanavir has been discontinued. Brecanavir had reached Phase II development.
The company said that they had been unable to develop a viable oral dosage formulation that achieved the drug levels required to treat multi-drug resistant HIV. GSK investigated several formulations of brecanavir. Ultimately, they could not overcome the limitations of the brecanavir molecule which made consistent delivery of target drug levels unachievable.
Clinical trial investigators and their Institutional Review Boards (IRBs) are being notified of the situation and directed to transition their patients to marketed antiretrovirals or appropriate treatments available through expanded access programmes. GSK will work with their clinical trial investigators to identify and implement alternative treatment arrangements for individual trial patients.
Source: GSK press release GSK Discontinues Clinical Development of Investigational Protease Inhibitor Brecanavir (640385), 18.12.06