The study found that 88% of participants receiving lenacapavir (n=21/24) experienced at least a 0.5 log10 reduction in HIV-1 viral load by the end of 14 days of functional monotherapy as compared with 17% of those receiving placebo (n=2/12).
Lenacapavir is being developed as a component of a long-acting regimen in combination with other antiretroviral agents for the treatment of HIV-1 infection.
If approved, lenacapavir would be the first HIV capsid inhibitor available for the treatment of HIV-1 infection.
In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced patients with multidrug resistance in combination with other antiretroviral drugs.
In CAPELLA, 36 adults with multi-class HIV drug resistance and a detectable viral load while on a failing regimen were randomized 2: 1 to receive oral lenacapavir or placebo for 14 days, in addition to continuing their failing regimen (functional monotherapy).
Of the 24 people randomized to the lenacapavir group, the median baseline viral load was 4.2 log10 copies/mL and 67% had a CD4 count of less than 200 cells/uL.
A statistically significant greater proportion of participants receiving lenacapavir met the primary endpoint of a viral load reduction of at least 0.5 log10 copies/mL from baseline compared with those receiving placebo at the end of the 14-day functional monotherapy period (88% vs. 17%, p
Tyra Biosciences doses first patient in TYRA-300 Phase 2 study for bladder cancer
argenx advances ARGX-119 to registrational study for congenital myasthenic syndromes
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
Hikma Pharmaceuticals USA announces USD1bn of new US investment
UCB reports positive Phase 3 results for fenfluramine in CDKL5 deficiency disorder