Revelation Biosciences finishes dosing for five single dose cohorts 

Summary

  • The pharma firm has got approval to begin a multiple dose cohort to the phase-1 of clinical study for REVTx-99.
  • The study was conducted to administer the safety and tolerability on increasing the doses of REVTx99.

 

Clinical stage life sciences company Revelation Biosciences Inc. announced on 3 February that it has been conceded approval to make an addition of a multiple dose cohort to its Phase-1 clinical study of REVTx‑99 in healthy volunteers by the Bellberry Human Research Ethics Committee (HREC) in Australia.

 

RVLNHV01 is a single site, placebo-controlled, single, escalating dose, trailed by multiple dose arm to govern the safety and tolerability of intranasal REVTx99 in healthy adult volunteers.  

 

The company said that it had completed the phase-1 single dose escalation portion of the study in January, which was conducted on 40 participants who were dosed with REVTx-99.

 

The main endpoints of the investigation were to determine the safety and tolerability of raising intranasal doses of REVTx99 and the pharmacodynamic impact of REVTx99 in sound adult volunteers.  

In November 2020, the company had declared the completion of dosing of the first cohort of its phase 1 clinical study in healthy volunteers, in which eight study participants were dosed with REVTx-99 in Australia.  

 

The company estimates the completion of the enrolment of multiple dose cohort of RVLNHV01 in February, which will be followed by the announcement of top-line data by the end of Q1 2021. 

It is also said that Revelation intends to begin with a Phase 1/2 study in early stage Covid19 patients during the H1 2021. 

(Source: Copyright © 2021 Kalkine Media Pty Ltd.)

 

What is REVTx-99? 

REVTx99 is a proprietary intranasal drop formulation, which is engaged in the advancement for the treatment and prevention of respiratory viral infection that also incorporates infection from Covid-19 virus, SARS CoV2.  

 

Board’s views 

James Rolke, CEO of Revelation, said that the company was pleased to have finished with the enrolment of all its single dose cohorts, that too with only mild local side effects.  

 

Rolke said that the company is focused on propelling a much-needed therapy for patients, especially with the detection of new variants of coronavirus. 

 

Based in Menlo Park, California, Revelation Biosciences Inc. is a clinical stage life sciences company that aims at treating immune diseases with the development of immunologic-based therapies. 

 

There are various product candidates of the company that are in their development stages. Some of them are specified below: 

 

REVTx99: is the leading therapeutic candidate of the company. Revelation has also planned the expansion of REVTx99 therapeutic indications, which will target early treatment and prevention of influenza A or B, parainfluenza, and respiratory syncytial virus. 

 

REVTx200: is an intranasal immunomodulator adjunct that is used to provide complete immunity, in combination with an intramuscular vaccination. The technology used in this medicine is the same as that in REVTx-99. 

 

REVDx501: is a rapid point of care diagnostic that is being developed by Revelation to detect any respiratory viral infection, regardless of virus type or strain, without the need for specialised instrumentation. 

 

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