Revelation Biosciences Inc. (NASDAQ: REVB) (the “Company” or “Revelation”), a clinical-stage life sciences company that is focused on the development of immunologic‑based therapies for the prevention and treatment of disease, today announced data base lock for its Phase 1b CLEAR clinical study to evaluate the effect of intranasal REVTx-99b on nasal challenge allergen in participants with allergic rhinitis to rye grass pollen. Topline data is expected in the last week of July 2022.
The Phase 1b, randomized, double-blind, placebo-controlled, crossover study design was conducted in Australia. The primary endpoint is to evaluate the effects of REVTx-99b versus placebo on safety and tolerability. Key exploratory endpoints include allergy symptoms (Total Nasal Symptom Score) and peak nasal inspiratory flow elicited by nasal allergen challenge. The study enrolled two cohorts: one cohort received study drug prior to nasal allergen challenge (the prophylactic cohort) and the second cohort received study drug after the nasal allergen challenge (the treatment cohort).
Allergic rhinitis, or hay fever, is an allergic reaction to tiny particles in the air called allergens. It is a common disorder that affects millions of patients annually and significantly impacts quality of life. Symptoms include sneezing, nasal congestion, and irritation of the nose, throat, mouth, and eyes. Allergic rhinitis can lead to complications in some cases including nasal polyps, sinusitis, and middle ear infections. People with severe chronic nasal congestion sometimes require surgery. While multiple treatment options are available, many of these still have limited efficacy in preventing symptoms, and may be associated with unwanted side-effects, thus better therapies are still needed.
“We are delighted to have the database lock completed in a timely and efficient manner and look forward to reporting the results soon,” said James Rolke, Chief Executive Officer of Revelation. “This is an important milestone taking us one step further in the development of a treatment for patients who suffer from allergic rhinitis – including patients with severe cases that may require invasive sinus surgery.”
REVTx-99b is a proprietary intranasal formulation in development for management of allergic rhinitis symptoms including chronic nasal congestion. The active ingredient has been shown in a Phase 1 clinical study to upregulate a protein, which competes for the native eotaxin receptor, CCR3, preventing eotaxin from recruiting eosinophils and basophils, thereby reducing recruitment of Th2 cells, and attenuating the allergic response.
Other clinical trial news of interest can be found here.