Revelation Biosciences Inc. Announces First Patient Enrolled and Dosed in Phase 1b Clinical Study of REVTx-99 for the Treatment of Allergic Rhinitis

Rhea-AI Summary

Revelation Biosciences (NASDAQ: REVB) has initiated patient enrollment for a Phase 1b clinical study of REVTx-99, targeting allergic rhinitis and chronic nasal congestion. The randomized, placebo-controlled study aims to assess the safety and tolerability of REVTx-99, with results expected in the first half of 2022. Allergic rhinitis affects approximately 8% of adults and 7% of children in the U.S., increasing asthma risk. REVTx-99 is designed to stimulate the nasal immune system, offering a potential treatment for millions suffering from these conditions.

Positive

• Initiation of Phase 1b clinical study for REVTx-99, enrolling approximately 28 participants.
• Key endpoints include safety, tolerability, and symptoms of allergic rhinitis.
• REVTx-99 shows promise in increasing protective cytokines based on Phase 1 data.

Negative

• None.

SAN DIEGO, Jan. 18, 2022 (GLOBE NEWSWIRE) -- 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 that the first patient has been enrolled and dosed in a Phase 1b clinical study to evaluate the potential utility of REVTx-99 for treating patients with allergic rhinitis and patients with chronic nasal congestion without polyps. The clinical study is being conducted in Australia.

“In the US, approximately 8% of adults and 7% of children have allergies that cause symptoms of allergic rhinitis, also called hay fever, and patients with allergic rhinitis have a threefold greater risk of developing asthma. The risk of developing asthma increases with more severe and persistent allergic rhinitis,” said James Rolke, Chief Executive Officer of Revelation. “REVTx-99 is being developed as a therapy for the millions of people who suffer from these symptoms each year – including those related to chronic nasal congestion, in which patients with severe cases may require invasive sinus surgery. The initiation of patient enrollment is an important step in our efforts to provide patients with safe and effective treatments for these chronic issues.”

The Phase 1b, randomized, double-blind, placebo-controlled, crossover design study is expected to enroll approximately 28 participants. The primary endpoint is to evaluate the effects of REVTx-99 versus placebo on safety and tolerability. Key secondary endpoints include allergy symptoms (Total Nasal Symptom Score) and peak nasal inspiratory flow elicited by nasal allergen challenge. The study will have two cohorts: one cohort will receive study drug before the nasal allergen challenge (the prophylactic cohort) and the second cohort will receive study drug after the nasal allergen challenge (the treatment cohort).

The company expects the topline data in the first half of 2022.

For more information on Revelation, please visit www.RevBiosciences.com.

About REVTx-99

REVTx-99 is a proprietary intranasal drop formulation in development for the prevention or treatment of respiratory viral infection and is broadly applicable to most infectious viruses including influenza A, influenza B, parainfluenza, rhinovirus, respiratory syncytial virus (RSV), SARS-CoV-2, and its variants. The active ingredient in REVTx-99 stimulates the nasal (mucosal) innate immune system via interaction with toll-like receptor 4 (TLR4) to produce protective cytokines including interferons and interferon-related proteins. These protective cytokines work in concert to blunt the ability of an invading virus to proliferate and survive. Phase 1 data showed REVTx-99 to be well-tolerated and to significantly increase intranasal protective cytokines.

In addition to viral infection, REVTx-99 is also being developed for management of allergic rhinitis symptoms and chronic nasal congestion without polyps. REVTx-99 upregulates a protein which competes for the native eotaxin receptor, CCR3, preventing eotaxin from recruiting eosinophils, thereby reducing recruitment of Th2 cells, and attenuating the allergic response.

About Allergic Rhinitis

Allergic rhinitis also called hay fever, is a very common disorder that affects millions of patients annually and the hallmark complaint of nasal obstruction significantly impacts the quality of life. It is an allergic reaction to tiny particles in the air called allergens. Symptoms include sneezing, nasal congestion and irritation of the nose, throat, mouth and eyes. Some treatment options may include antihistamines, anti-inflammatory nasal sprays, anti-leukotrienes, and surgery. Allergic rhinitis can lead to complications in some cases: nasal polyps, sinusitis, and middle ear infections. People with severe chronic nasal congestion sometimes need surgery.

About Revelation Biosciences Inc.

Revelation Biosciences, Inc. is a clinical-stage life sciences company focused on the development of immunologic-based therapies for the prevention and treatment of disease. Revelation has several product candidates in development. REVTx-99, the lead therapeutic candidate, is an intranasal immunomodulator to prevent or treat infections caused by various respiratory viruses such as SARS-CoV-2, including its variants, influenza A and B, parainfluenza, rhinovirus, and RSV. REVTx-99 is also being developed for other indications such as: allergic rhinitis and chronic nasal congestion. REVTx-200 is an intranasal immunomodulator adjunct to be used in combination with an intramuscular vaccination for more complete immunity. REVTx-200 is based on the same technology used in REVTx-99. In addition to Revelation’s therapeutic pipeline, Revelation is also developing REVDx-501, a rapid home use diagnostic that can be used to detect any respiratory viral infection, regardless of virus type or strain, without the need for specialized instrumentation.

For more information on Revelation, please visit www.RevBiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These forward-looking statements are generally identified by the words "anticipate", "believe", "expect", "estimate", "plan", "outlook", and "project" and other similar expressions. We caution investors that forward-looking statements are based on management’s expectations and are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those anticipated by the forward-looking statements. Revelation cautions readers not to place undue reliance on any such forward looking statements, which speak only as of the date they were made. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or competitive factors; risks relating to the successful development of Revelation’s product candidates; the clinical utility of an increase in intranasal cytokine levels as a biomarker of viral infections; the ability to complete planned clinical studies of REVTx-99; risks relating to the successful completion of RVL-CLR01 and RVL-VRL01 clinical studies; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the FDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for REVTx-99 and expanded indications, REVTx-200, REVDx-501, or any other product candidates; potential indications for which product candidates may be developed; the potential impact that COVID-19 may have on Revelation’s suppliers, vendors, regulatory agencies, employees and the global economy as a whole; the ability of Revelation to maintain the listing of its securities on NASDAQ; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the SEC by Revelation.

Company Contacts

Sandra Vedrick
Vice President, Investor Relations & Human Resources
Revelation Biosciences Inc.
Email: svedrick@revbiosciences.com

and

Chester Zygmont, III
Chief Financial Officer
Revelation Biosciences Inc.
Email: czygmont@revbiosciences.com

Media contact:
Kristin Faulder
kristin@heurisay.com

FAQ

What is the purpose of the Phase 1b clinical study for REVTx-99?

The study evaluates the safety and tolerability of REVTx-99 in treating allergic rhinitis and chronic nasal congestion.

When are the results of the REVTx-99 study expected?

Topline data from the study is expected in the first half of 2022.

What are the primary endpoints of the REVTx-99 study?

The primary endpoint is to assess safety and tolerability compared to placebo.

How does REVTx-99 work for allergic rhinitis?

REVTx-99 stimulates the nasal immune system to produce protective cytokines, potentially alleviating allergy symptoms.

What are the expected outcomes for patients with allergic rhinitis?

The study hopes to demonstrate effective treatment to mitigate symptoms and improve quality of life.