Enrollment Done for COVID-19 Drug Trial

January 13, 2022

Part 2 of First Wave BioPharma’s RESERVOIR trial of niclosamide to remove the SARS-CoV-2 virus from the GI tract is underway, noted a ROTH Capital Partners report.

For the second part of First Wave BioPharma Inc.’s (FWBI:NASDAQ) Phase 2 RESERVOIR trial, 150 patients were enrolled in the United States, India, and Ukraine, reported ROTH Capital Partners analyst Brian Aschoff.

In this Part 2 study, participants will be administered FW-COV for 14 days, Ashoff described. The trial’s primary endpoint is the clearance rate of SARS-CoV-2 from participants’ stool. To determine this, the presence of SARS-CoV-2 in patients’ stool samples will be measured for six weeks following treatment. With Part 2 so far, no serious adverse side effects have been reported.

The analyst noted that about 18% of patients infected with COVID-19 also have virus-related gastrointestinal symptoms. That percentage, though, will likely increase with the expected rise in number of infections resulting from vaccination-resistant variants.

Regarding RESERVOIR Part 1, Aschoff said ROTH expected the recommendation from the Independent Data Monitoring Board to be positive. This primarily is because niclosamide is not a new drug but, rather, one that has been used for decades, initially as an anthelmintic, a destroyer of parasitic worms.

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Disclosures for ROTH Capital Partners LLC, First Wave BioPharma Inc., Jan. 6, 2022

Within the last twelve months, ROTH Capital Partners, or an affiliate to ROTH Capital Partners, has received compensation for investment banking services from First Wave BioPharma, Inc.
ROTH makes a market in shares of First Wave BioPharma, Inc. and as such, buys and sells from customers on a principal basis.
Shares of First Wave BioPharma, Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH. Copyright 2022. Member: FINRA/SIPC.