by Manasi Vaidya in New York
Revelation Biosciences is in the midst of a Series A $10–12m raise to fund the development of its Covid-19 therapeutic and diagnostic assets, with plans to close the raise by next month, said CEO James Rolke.
The company then plans to start a $50m–60m Series B raise with a YE21 close to fund the company’s various ongoing and upcoming clinical activities, he added.
The first raise will allow the company to complete the ongoing Phase I healthy volunteer study evaluating its lead therapy REVTx-99, and then initiate a Phase II trial in nonhospitalised Covid-19 patients in 2Q21, said Rolke. The company plans to file an IND to the FDA for the Phase II in January or February, he added.
The Series B will be used to fuel potential Phase III REVTx-99 development in COVID-19 as well as a Phase II influenza challenge study, Rolke added. The influenza trial is earmarked for in 2H21, he said. REVTx-99 is an intranasal immunomodulator that stimulates the innate immune response and is agnostic to any viral pathogen.
Going back to the Series A, it will also be used to fuel an emergency use authorisation (EUA) application to the FDA in early 2021 for the company’s diagnostic REVDx-501, designed to detect any respiratory viral infection, Rolke said. To use the diagnostic test, a person could swab their anterior nares and place it on an application pad to get a quick result, which would indicate if the person had any viral infection, he explained. If positive, the person could then get a confirmatory Covid-19 RT-PCR test, he added.
Revelation was founded in June 2020 with $1m in seed funding from different undisclosed sources, said Rolke. Revelation is now raising the Series A through institutional investors and high net worth individuals predominantly by itself, but has engaged an undisclosed bank to complete the round, he said, adding the same bank will be used for the Series B.
In the meantime, the Phase I REVTx-99 heathy volunteer trial (ACTRN12620001104943) is evaluating five doses between 5–100μg and has enrolled the first three cohorts as of last week, said Rolke. Each cohort is enrolling eight volunteers, with six receiving REVTx-99 and two receiving placebo, he said. The Phase I readout is expected in January, he added.
While the Phase II REVTx-99 trial protocol in Covid-19 is still being designed, Rolke said it will include two arms evaluating two different doses, with a third arm for placebo. It will enroll between 50 and 100 nonhospitalised patients in each arm. The primary endpoint will evaluate hospitalization rates, while secondary endpoints will measure biomarkers, he added. The company will most likely collaborate with an academic center treating a high volume of Covid-19 cases to conduct the study, he noted.
Since REVTx-99’s mechanism is agnostic to the virus causing the infection, Revelation plans to develop it as an early treatment and prophylactic for high-risk populations for other respiratory viruses, said Rolke. To this effect, the company plans to run a Phase II viral challenge study in influenza by contracting an academic institute that is experienced in running such studies, he added. REVTx-99 interacts with toll-like receptor 4 leading to the stimulation of protective cytokines like Type I and Type II interferons.
Manasi Vaidya is an Associate Editor for Pharmaceutical Technology parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.