Leronlimab (CytoDyn) is a humanized monoclonal antibody directed against C-C chemokine receptor 5 (CCR5), which is a co-receptor required for the attachment and entry of CCR5-tropic HIV-1 viruses into host cells. Leronlimab blocks the interaction between CCR5 and the viral gp120 protein, thus preventing HIV from attaching to and entering host cells. Importantly, leronlimab does not antagonize the normal physiological function of CCR5 in mediating immune responses, which is expected to reduce the potential for off-target effects. CytoDyn filed a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) in March 2019 for the treatment of multidrug-resistant HIV-1 infections in combination with optimized background therapy. The drug is also being investigated as a maintenance monotherapy in HIV-1 patients who have achieved stable virologic suppression with their current treatment regimen. Separately, leronlimab is in Phase II development for the treatment of graft versus host disease.
Following its anticipated approval in Q4 2019, leronlimab is poised to achieve rapid uptake in the US salvage setting because of the high unmet need and relative lack of competition in this segment. While the multidrug-resistant population is very small because of the availability of a plethora of highly effective regimens for patients in earlier lines of therapy, CytoDyn is expected to price leronlimab at a similar price to its main rival, Trogarzo (ibalizumab; Theratechnologies/TaiMed Biologics), which commands an exceptionally high annual list price of approximately $118,000 per patient. Thus, leronlimab’s anticipated premium pricing will allow CytoDyn to generate substantial revenues from a small patient pool. While EU countries would be unlikely to tolerate such a high premium over existing oral treatments, it should be noted that leronlimab’s pivotal studies did not include any EU study sites, therefore additional studies would likely be required for EU approval.
4 Drug Overview
5 Product Profiles
5 leronlimab : HIV
LIST OF FIGURES
9 Figure 13: Datamonitor Healthcare’s drug assessment summary of Delstrigo for HIV
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of leronlimab for HIV
11 Figure 14: Delstrigo sales for HIV across the US and five major EU markets, by country, 2018–27
13 Figure 15: Datamonitor Healthcare’s drug assessment summary of Descovy for HIV
LIST OF TABLES
6 Table 1: Leronlimab drug profile
8 Table 2: Late-phase trials of leronlimab for HIV
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