How this could be achieved using the proprietary platform of TFF Pharmaceuticals and why it could work are discussed in a ROTH Capital Partners report.
In an April 7 research note, ROTH Capital Partners analyst Jonathan Aschoff discussed the potential of applying TFF Pharmaceuticals Inc.'s (TFFP:NASDAQ) thin film freezing (TFF) technology to an existing drug to create a possible COVID-19 therapy.
The hypothesis is that the biopharma's TFF platform could be used on niclosamide, turning it into an inhalable version, thereby improving its pharmacokinetics because it has low absorption and oral bioavailability at around 10%, Aschoff explained.
An essential drug according to the World Health Organization, niclosamide is an anthelminthic (used to treat tapeworm infestations), has several mechanisms of action and has broad antiviral activity. "Niclosamide can inhibit SARS-associated coronavirus replication and totally abolish viral antigen synthesis," according to a recent publication (doi:10.1021/acsinfecdis.0c00052) reviewed by Aschoff, he noted.
Currently, researchers at the University of Texas at Austin (UT), which is affiliated with Texas-based TFF Pharmaceuticals through various research agreements, are working on such an approach.
UT researchers are using novel drug delivery formulation technologies to increase the absorption of niclosamide, thereby optimizing it for both oral and inhaled administration "that could best treat COVID-19 symptoms in severely affected patients by delivering the drug directly to the most problematic site of infection," described Aschoff. Using TFF Pharmaceutical's thin film freezing technology, the UT team is turning niclosamide into "micronized crystalline dry powder formulations and an amorphous brittle matrix powder."
Aschoff pointed out, "We favor existing drugs that have a known adverse event profile from both clinical and commercial use, and to this end TFF Pharmaceuticals is performing an exhaustive review of U.S. Food and Drug Administration approved drugs that could be repurposed to treat COVID-19 patients or used prophylactically."
ROTH has a Buy rating and a $15 per share target price on TFF Pharmaceuticals, whose current share price is about $4.96.
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Disclosures from ROTH Capital Partners, TFF Pharmaceuticals, Company Note, April 7, 2020
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
ROTH makes a market in shares of TFF Pharmaceuticals, Inc. and as such, buys and sells from customers on a principal basis.
Shares of TFF Pharmaceuticals, 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.