Revive Therapeutics (CSE: RVV) this morning announced that on the heels of receiving FDA approval for phase 3 clinical trials of Bucillamine in the treatment of COVID-19, it currently intends to begin the clinical trials in September. The company is currently in the process of finalizing agreements and aligning resources to conduct the trials.
Currently, Revive intends to utilize up to 10 clinical trial sites across the US, while opening screening for patients in the third quarter. Target locations currently include regions of the country heavily affected by the virus, including California, Florida, Texas, and Arizona. Vendor agreements are in the process of being finalized for numerous aspects of the trial, including project management, medical monitoring, and data management.
Other developments that have positively impacted the company as of late, outside of the developments exhibited by its Bucillamine study, include the recent news that four Canadians suffering from terminal illnesses have been approved for psilocybin therapy. The use of psilocybin has been approved specifically for the treatment of anxiety, with the ruling marking the first time such a legal exemption has been granted within the country.
The exemption was applied for on compassionate grounders to the controlled drugs and substances act, since there are “currently no approved therapeutic products containing psilocybin in Canada.”
The development is significant for Revive, given that the company is currently investigating novel oral dosage forms of psilocybin, which include dissolvable thin films or tablets. The dosage forms are based on the firms patent-pending psilocybin formulations as well as exclusively licensed drug delivery tech. That tech comes from the Wisconsin Alumni Research Foundation, through the University of Wisconsin-Madison.
Formulation development plans are currently being prepared for Revive to pursue clinical studies for indications not being evaluated currently with psilocybin. The company is currently focused particularly on the drug delivery methods of dissolvable tablets and oral film strips as a result of its easy consumption format, with the company focused on the potential of rapid onset of action and time-release compositions. Further, the company also holds within its strong portfolio provisional patent applications for methods of production of psilocybin-based formulations, as well as methodologies for psilocybin extraction and crystallization.
In terms of funding for its multiple studies, it is believed that given the recent re-rating of the equity, a portion of the currently outstanding warrants held by the company have been exercised, with up to $5.8 million currently eligible to be exercised as of the latest filings by the company. Subsequent to the end of the quarter, we know that at least $519,410 has hit the treasury from such exercises, however given the sustained strength of the company that figure is likely now far higher, meaning the company is currently well capitalized to conduct such trials and further research.
Revive Therapeutics last traded at $0.36 on the CSE.
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