Revelation Biosciences announced that the Australian Therapeutic Goods Administration has okayed a Phase 1 clinical study of the company’s REVTx‑99 intranasal phosphorylated hexaacylated disaccharide (PHAD), which Revelation is developing for the treatment of COVID‑19. According to the company’s web site, “REVTx-99 acts by stimulating the innate immune response via interaction with toll-like receptor 4 (TLR4) and activation of the TIR-domain-containing adapter-inducing interferon-β (TRIF) pathway to produce protective cytokines including Type I and Type II interferons.”
The company said that it expects to initiate the RVL‑HV01 SAD study in the fourth quarter of 2020, with topline data anticipated in the first quarter of 2021. The study is expected to enroll as many as 32 healthy volunteers. Following the completion of the Phase 1 study, Revelation intends to conduct a Phase 2 study in patients with COVID-19 who are at risk for hospitalization.
Revelation CEO James Rolke commented, “We are pleased that the start of a Phase 1 clinical study of REVTx-99 has been approved in Australia. Initiation of this clinical study is an important step in our quest to bring this potential treatment for COVID-19 to fruition. Our dedicated team continues to work around the clock as we aim to deliver topline data in accordance with our corporate goals.”
Read the Revelation Biosciences press release.