Revive Therapeutics reports progress with Phase III COVID-19 trial
The pharmaceutical industry has been hard at work exploring potential treatments for COVID-19 ever since the deadly virus first reared its head. One firm, Revive Therapeutics, reports it has made headway in exploring the safety and efficacy of a candidate: Bucillamine, an antirheumatic agent, in patients dealing with mild to moderate cases of COVID-19.
Michael Frank, CEO and chairman of Revive Therapeutics, spoke with Outsourcing-Pharma about the life-sciences industry’s work toward viable COVID-19 treatments, and the progress his firm has made with its own candidate.
OSP: Could you please talk about the history so far of COVID-19 treatment discovery, development, and research?
MF: The search for drugs and vaccines to treat or prevent COVID-19 began fairly quickly. By March 2020, when we saw that the COVID-19 pandemic was getting worse, our team began our work with Bucillamine which we had experience with, and an application was sent out to the FDA by that summer.
There are several therapeutics that could add a lot of value to the treatment of COVID-19. Revive offers a pill that focuses on antirheumatic and anti-inflammatory treatment, whereas Roche, Pfizer, and Merck are antiviral pills. Regardless of the type, antiviral or anti-inflammatory, there’s an urgent need for oral therapeutics.
Revive is well into our Phase III clinical trial. The landscape has changed in the last few months, and things are more level in terms of a playing field with all the major companies focusing on therapeutics, too.
OSP: Could you please talk about how Revive came to work on Bucillamine—how did you discover its COVID-19 potential, and how has your work progressed to now?
MF: We have a history and an open IND for the treatment of gout in the clinical development with Bucillamine, initially a treatment for rheumatoid arthritis. We ran a phase 2a trial around gout in 2015 with Bucillamine. After looking at the data, based on its anti-inflammatory history and a few other properties, it led us to advance our efforts in reviving and repurposing the drug as a treatment for COVID-19. The drug has also been shown to be effective for inflammation around reperfusion injury and organ transplantation.
Once the FDA had the chance to look at the historical data of Bucillamine, safety and profile, and our open IND they fast-tracked the trial into a Phase III. The current trial, led by Kelly Mckee and our team is now looking at 600 patients by the end of September 2021 and finishing the 1000-person study in Q4. We have made tremendous progress over the last few months by engaging over 40 clinical sites, and we plan to expand to 50 sites and target COVID hot spots.
OSP: Please tell us some of the properties of the drug, and notable findings in the research to date, that are helping Revive feed positive about the treatment’s chances of achieving full approval down the road.
MF: I can’t really get into the core details at the moment since we’re still in a clinical trial, but you are more than welcome to read about our ongoing study posted on clinicaltrials.gov. At a high level, the history of Buccillamine is an anti-rheumatoid and inflammatory drug for arthritis. It has properties that enhance glutathione, a natural substance in the body and an antioxidant.
Buccillamine is a powerful mechanism to produce glutathione. In fact, it’s 16x more potent than N-Acetylcysteine/NAC, a drug that is also currently in trials as a treatment for COVID-19.
In the event that someone gets COVID-19 which causes inflammation there usually is a cytokine storm. This overproduction of cytokines causes inflammation around a lot of the organs including the lungs. Based on the history of this drug, we’re confident that it will have good efficacy.
OSP: To date, COVID-19 treatment has focused on symptoms; why is it preferable to have the option of an approved treatment for the virus itself?
MF: Although the availability of the vaccine has been shown to reduce hospitalization, breakthrough infections are happening. Whether someone is vaccinated, yet to be vaccinated or vaccine-hesitant, people are still getting COVID. Vaccines also have an issue with efficacy after a certain amount of time, and it’s hard to move vaccines out to third-world countries and areas that don’t have access to them.
Some people talk about monoclonal antibodies, which is another therapeutic, but it’s hard to take because it's intravenous. There’s a need for oral treatments.
This virus comes with a lot of side effects, and the drug we have has a strong history and safety profile. It can be taken on its own or in conjunction with other treatments. Oral therapeutics are essential for logistic deployment.
OSP: Do you have anything to add?
MF: These types of viruses will potentially continue, whether Delta stays for a while or it mutates to become another variant. A pill/ treatment is highly beneficial and essential as these are not tied to only one strain, it can work with different forms of a virus and that’s very important.