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

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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.

“As highly contagious and vaccine evasive SARS-CoV-2 variants continue to emerge, along with new restrictions on access to certain therapies previously available under Emergency Use Authorization, there is an ongoing need for accessible antiviral treatments that can be administered in an outpatient setting,” said Dale Christensen, Ph.D., Head of Clinical Development at TFF Pharmaceuticals. “We believe that our formulation of niclosamide will be able to be administered using an approved inhaler and acts directly at the primary site of infection, which we hope will show acceptable efficacy in the next phase of development now that we have completed enrollment in our Phase 1 safety study. Importantly, niclosamide targets human cell pathways rather than the SARS-CoV-2 virus itself, so it is not affected by mutations in the spike protein and could theoretically work against any emerging variant. We are excited to report more complete safety results and look forward to working with our partner on advancing into late-stage studies with the recommended dose.”

Following results from the Phase 1 trial, UNION Therapeutics A/S has an option to exclusively license the dry powder formulation of niclosamide and is responsible for the next phase of development.

About TFF Pharmaceuticals’ Thin Film Freezing Technology Platform
TFF Pharmaceuticals’ Thin Film Freezing (TFF) platform was designed to improve the solubility and absorption of poorly water-soluble drugs and is particularly suited to generate dry powder particles with properties targeted for inhalation delivery, especially to the deep lung, an area of extreme interest in respiratory medicine. The TFF process results in a “Brittle Matrix Particle,” which possesses low bulk density, high surface area, and typically an amorphous morphology, allowing the particles to supersaturate when contacting the target site, such as lung tissue. Based upon laboratory experiments the aerodynamic properties of the particles are such that the portion of a drug deposited to the deep lung has the potential to reach as high as 75 percent.

About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing, or TFF, technology platform. Early testing confirms that the TFF platform can significantly improve the solubility and absorption of poorly water-soluble drugs, a class of drugs that comprises approximately one-third of the major pharmaceuticals worldwide, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 42 patents issued or pending in the US and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.

About UNION Therapeutics A/S
UNION therapeutics is a privately-held, multi-asset, clinical stage, biotechnology company focused on immunology and infectious diseases. The company is currently working with two complementary chemistry classes, spanning immunology and microbiology with six programs in clinical development. UNION is headquartered in Hellerup, Denmark, and led by an international team combining biotech entrepreneurs and senior pharma executives, with a track record of developing and launching more than fifteen marketed drugs. Read more at www.uniontherapeutics.com.

SAFE HARBOR
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder versions of niclosamide, and the Company’s plans to add to its existing pipeline of product candidates. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder version of niclosamide, (ii) assuming that the Company is successful in its clinical testing of niclosamide, that the Company will be able to enter into a licensing arrangement with UNION on terms favorable to the Company, if at all, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (v) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. TFF Pharmaceuticals cautions readers not to place undue reliance on any forward-looking statements. TFF Pharmaceuticals does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law.

Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com

Media Contact:
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
gschanker@lifescicomms.com

Source: TFF Pharmaceuticals, Inc.

  1. Identification of antiviral drug candidates against SARS-CoV-2 from FDA-approved drugs. Sangeun Jeon, Meehyun Ko, Jihye Lee, Inhee Choi, Soo Young Byun, Soonju Park, David Shum, Seungtaek Kim. DOI: 10.1128/AAC.00819-20

  2. Niclosamide inhalation powder made by thin-film freezing: Multi-dose tolerability and exposure in rats and pharmacokinetics in hamsters. Miguel O. Jara, Zachary N. Warnken, Sawittree Sahakijpijarn, Chaeho Moon, Esther Y. Maier, Dale J.Christensen, John J. Koleng, Jay I. Peters, Sarah D. Hackman Maier, Robert O. Williams III. DOI: 10.1016/j.ijpharm.2021.120701