Positive study findings for N6LS, an investigational, broadly neutralising antibody (bNAb), could indicate a potential new approach for the treatment of HIV.
ViiV Healthcare, a specialist HIV company owned by GSK, Pfizer and Shionogi, presented positive findings from its Phase IIa proof-of-concept study of N6LS at the 30th HIV Glasgow Conference.
The drug is being studied at two dosing levels – a high dose and ten-fold lower dose (40mg/kg and ~4mg/kg (280mg), respectively), in adults living with HIV.
The POC study showed that a single infusion of N6LS demonstrated strong antiviral efficacy at both doses while also being well-tolerated by study participants.
N6LS is a bNAb that works by binding to a specific site (gp120) on the surface of HIV that prevents its entry into immune system cells (CD4+ T-cells). By blocking HIV’s entry into human CD4+ cells, the virus is unable to replicate, and the HIV transmission process may be prevented.
N6LS was evaluated as monotherapy in the BANNER study, which included 14 treatment-naïve adults living with HIV. Virologic response to the bNAb was seen in 13 of the 14 participants.
When administered at 40mg/kg, N6LS led to a decline in viral load consistent with other bNAbs. The viral load decline and duration of response observed in the 4mg/kg dose exceeded efficacy reported by other bNAbs at similarly low doses.
Pedro Cahn, Scientific Director, Fundación Huésped, Professor of Infectious Diseases, Buenos Aires University Medical School, and Investigator for the Banner Study, said: “As we investigate bNAbs as an entirely new approach to HIV science, it’s particularly exciting to see that this bNAb exceeded the efficacy reported by other bNAbs at certain low-dosing levels. We look forward to studying this promising medicine further.”
ViiV Healthcare expects to begin a phase IIb study of N6LS in combination with other anti-retrovirals in 2023.