Get the Latest Investment Ideas Delivered Straight to Your Inbox. Subscribe

News Update


Life Sciences Firm Submits IND Application to FDA for Phase 3 COVID-19 Study
News Update

Share on Stocktwits


Revive Therapeutics submitted an Investigational New Drug Application to the FDA for a Phase 3 confirmatory study of Bucillamine for treatment in SARS-CoV-2.

In a news release, Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced that "it has submitted its Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 3 confirmatory study for Bucillamine as a potential treatment in COVID-19." The firm indicated that after the FDA grants permission for the IND to go forward, it plans to proceed with a randomized, double-blind, placebo-controlled study in Q3/20 of Bucillamine in patients with mild-moderate COVID-19.

Revive Therapeutics' CEO Michael Frank commented, "We are very pleased in achieving this major milestone of filing our IND for a Phase 3 confirmatory study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, which was based on the recommendation from the U.S. FDA from our pre-IND meeting earlier this year...We are preparing plans for initiating the Phase 3 study upon the IND becoming active by the U.S. FDA and we look forward to advancing Bucillamine as a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally."

The firm advised that the Phase 3 randomized clinical trial is designed to study Bucillamine in patients with mild-moderate COVID-19 and that the study will enroll up to 800 patients who will receive either a 100 mg or 200 mg dose of Bucillamine or a placebo for up to 14 days.

The company noted that the primary objective in the study will be to compare frequency of hospitalization and mortality in patients with mild-moderate COVID-19 receiving Bucillamine therapy compared to the controlled placebo group. "The primary endpoint is the proportion of patients with the following outcomes attributed to COVID-19 from time of the first dose through Day 28 following randomization: death, alive and hospitalized, and alive and not hospitalized."

The firm noted that an Independent Data and Safety Monitoring Board will perform an interim analysis after 210 patients have been treated and followed up for a total of 28 days after randomization. The company stated that the Bucillamine dosage level with the best achieved results will then be identified and then randomized 2:1 to the placebo as the trial progresses.

The company advised that "it is not making any express or implied claims that its product has the ability to eliminate or cure COVID-19 (SARS-2 Coronavirus) at this time."


1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Revive Therapeutics. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Revive Therapeutics, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Want to read more about Biotechnology / Pharmaceuticals investment ideas?
Get Our Streetwise Reports Newsletter Free and be the first to know!

A valid email address is required to subscribe