Biopharma Gets FDA Approval for Phase 3 COVID-19 Trial

Source: Streetwise Reports   08/04/2020

Revive Therapeutics’ trial will test Bucillamine in patients with mild to moderate COVID-19.

Revive Therapeutics Ltd. (RVV:TSX.V; RVVTF:OTCMKTS) announced in a news release it received a green light from the U.S. Food and Drug Administration to conduct a Phase 3 clinical trial of Bucillamine in patients with mild to moderate COVID-19.

“The FDA approval of the Phase 3 study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19 is a tremendous milestone for Revive and I am very proud of the dedication of our team and partners to bring forward a potential new treatment option for patients with a confirmed diagnosis of COVID-19 globally,” said Michael Frank, Revive’s CEO. “We thank the FDA for recognizing the importance of this Phase 3 study and we are now focused on executing on our plans for initiating the clinical trial in an expeditious manner.”

The study will evaluate the safety and efficacy of Bucillamine. Up to 1,000 patients will be randomized on a 1:1:1 basis to receive Bucillamine 100 milligrams three times a day, Bucillamine 200 milligrams three times a day or a placebo three times a day, for up to 14 days.

The primary endpoint, the company noted, is the proportion of patients whose clinical outcome is hospitalization or death after the time of their first dose. Efficacy will be determined by comparing various elements between patients receiving Bucillamine and patients receiving a placebo. Those elements will include clinical outcome, disease severity using the National Institute of Allergy and Infectious Diseases’ eight-category COVID ordinal scale, supplemental oxygen use and COVID-19 progression.

Safety will be assessed through adverse events reported before treatment and those during and immediately after treatment, along with certain lab test results, vital signs and peripheral oxygen saturation levels.

After 210 patients are treated and followed for 28 days afterward, an independent data and safety monitoring board will conduct an interim analysis. The board will determine which dose had better results, after which patients will be randomized 2:1 to that Bucillamine dose or to a placebo.

Additional interim analyses will occur after 400, 600 and 800 patients have been followed for 28 days post treatment.

[NLINSERT]

Disclosure:
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.