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TFF Pharmaceuticals Completes Enrollment in Phase 1 Study Evaluating Inhaled Formulation of Niclosamide to Treat COVID-19

Complete Safety Data Anticipated by End of 1Q 2022

Safety Management Committee Has Recommended 12 mg as Phase 2 Dose

Niclosamide is a Potent Inhibitor of SARS-CoV-2 with Activity Against Multiple Variants

AUSTIN, Texas, Jan. 27, 2022 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced that it has completed enrollment of 40 healthy subjects in its Phase 1 clinical trial (CT.gov identifier NCT05168644) of a dry powder formulation of niclosamide, an antiviral treatment with potential to address COVID-19 and other respiratory viral diseases.

“We are pleased with the continued progress of TFF’s internal pipeline including inhaled niclosamide, which we believe could provide a safer, convenient and effective option to treat COVID-19,” said Glenn Mattes, CEO of TFF Pharmaceuticals. “We are grateful to our team and collaborators for their work to advance this program in the backdrop of continued uncertainties of the COVID-19 pandemic. We look forward to sharing the detailed safety data from the Phase 1 study later this quarter and to sharing additional updates on the progress of our Phase 2 voriconazole and tacrolimus programs.”

Originally approved as an oral anthelmintic drug by the U.S. Food and Drug Administration in 1982, niclosamide was recently shown to exhibit potent antiviral activity against SARS-CoV-21 but has limited water solubility as well as low absorption and bioavailability when administered orally. TFF Pharmaceuticals intends to utilize its Thin Film Freezing technology to produce an inhaled formulation of niclosamide to target the lungs directly where SARS-CoV-2 infection occurs, avoiding gastrointestinal side effects and overcoming the bioavailability limitations of systemic administration. TFF previously completed a preclinical in vivo efficacy study that showed a seven-fold reduction in lung viral load in a hamster model when dry powder niclosamide was administered 24 hours after inoculation with SARS-CoV-2 when the disease was already severe.2

The Phase 1 trial consisted of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) phase. The SAD phase of the trial consisted of single inhalation doses of 0.5, 2.0, and 6.0 mg in three cohorts of healthy volunteers, including six volunteers that will receive active drug and two that will receive placebo, while the MAD phase consisted of doses of 3.0 and 6.0 mg administered twice per day (BID) for 4.5 days (9 total doses). The Safety Management Committee has had no questions or concerns about safety and has recommended the 6.0 mg BID (12 mg total daily dose) as safe for progression into Phase 2 testing.