Revive Therapeutics May Seek FDA Approval To Amend Phase 3 Endpoints In Bucillamine Trial To A Symptoms Focus
Though it has not yet been officially confirmed, it appears as though Revive Therapeutics is on track to seek approval from the Food and Drug Administration (FDA) to amend the third phase endpoints of its Bucillamine trial.
The suggested amendment of the trial’s Phase 3 endpoints will shift the focus toward patient symptoms. This development has the potential to be important in the context of psychedelics investing as Revive Therapeutics is a publicly traded company on the over-the-counter market with a symbol of RVVTF. Revive is also traded on the CSE with the symbol of RVV and the Frankfurt exchange with the symbol of 31R.
Details Of The Potential Pivot
Revive Therapeutics is currently working through its Phase 3 clinical trial to determine if Bucillamine successfully reduces the hospitalization rate and death rate of patients saddled by COVID-19, also known as coronavirus. Psychedelics investors will find it interesting to note the FDA recently altered Adamis Pharmaceuticals toward a symptoms endpoints. Adamis Pharmaceuticals is also a publicly traded company with the symbol of ADMP.
The logic in the FDA shifting Adamis toward the systems endpoint is likely the result of both groups acknowledging there has been a reduction in coronavirus hospitalizations and death stemming from the comparably weak Omicron strain of the virus.
Why The Change In Stance Matters
If the FDA ends up amending Revive’s endpoints for its Phase 3 clinical study similar to how it altered the course of the Adamis study, the new symptoms benchmark will pave a path for filing for EUA sooner than originally expected. It is also worth noting that the anticipated pivot is not guaranteed to occur as Omicron and other comparably weaker strains of the original coronavirus still have the potential to amount to a considerable number of hospitalizations and deaths in the days and weeks ahead.
Psychedelics investors will find it interesting to note that Adamis only has data pertaining to about 200 patients, meaning it is challenging to draw overarching conclusions from such a limited sample size. In contrast, Revive has data pertaining to around 700 patients.
Revive, a specialty life sciences business that researches and develops therapeutics to treat patients with medical needs, initially launched the Phase 3 clinical study to better understand the efficacy and safety of Bucillamine. Bucillamine is an oral drug that has antiviral and anti-inflammatory properties. The drug was designed to treat patients suffering from moderate to mild coronavirus.
Revive collaborated with Delta Health on the study in which clinical trials were conducted by Turkey’s largest hospital group MLP care. All in all, 13 unique clinical research sites were selected to generate enrollment for the study. Full enrollment is anticipated by the end of the current year’s second quarter. The company’s brass is also hard at work preparing a regulatory package to submit to the international regulatory authorities and the FDA with the goal of drug approval.
The rise of the new coronavirus variant BA.2 reflects the need for robust anti-oxidant and anti-inflammatory drugs, meaning there is still a strong need for Buccilamine and similar treatments. Revive’s stock jumped 25% in the previous five days of trading, likely as a result of the rumblings about the potential study shift as detailed above.