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Chimerix First-Quarter Financials Non-event; Expanding Brincidofovir Into AdV Infections

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By on BioPharma, Financial

The recently initiated brincidofovir program in treatment of AdV infection and the potential initiation of a third study evaluating brincidofovir in the treatment of solid organ transplants (SOTs), namely in renal transplants, by year end 2014, have increased the need for capital beyond the levels originally projected at the time of the initial public offering. Thus, we anticipate the company will likely choose to opportunistically raise additional capital ahead of the preliminary data readout of SUPPRESS, expected in mid-2015.

In March, the company initiated a pilot study investigating the use of brincidofovir for the treatment of AdV infection in immune-compromised adult and pediatric patients. The pilot study was designed in agreement with the Food and Drug Administration (FDA) to provide patients access to brincidofovir and gain understanding of brincidofovir safety and efficacy profile in the setting, while discussions regarding the protocol design of a Phase III study in the setting continued with the agency; the company stated that data from the pilot study will be used to inform the company and regulators regarding the appropriate design of a pivotal study. We anticipate the finalization of the protocol during second half 2014.

The pilot study is a multicenter study investigating the safety and efficacy of brincidofovir in the treatment of early versus late AdV infection. Although the company originally set an expected enrollment of 20 subjects in the study, Chimerix commented on the call that the number of subjects eligible for enrollment would be left open. The company clarified that both adults and children with AdV would be eligible. Subjects will be tested for AdV infection detected during asymptomatic AdV viremia or during symptomatic AdV infection. All will be treated for 12 weeks, with adults receiving 100 mg of brincidofovir bi-weekly (BIW) and children up to 12 years of age receiving weight-based doses of 2 mg/kg BIW, not to exceed a total dose of 200 mg/week. The primary endpoint of the study is overall mortality at week 24. Preliminary results of the study are expected during second half 2014.

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