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

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Full safety data expected by end of Q1 2022

Safety management committee recommended 12mg as phase 2 dose

Niclosamide is a potent SARS-CoV-2 inhibitor 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 pharmaceutical products based on its Thin Film Freezing patent ( 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 the potential to treat COVID-19 and other viral respiratory illnesses.

“We are pleased with the continued progress of TFF’s internal pipeline, including inhaled niclosamide, which we believe may provide a safer, more 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 in moving this program forward in the context of the continuing uncertainties of the COVID-19 pandemic. We look forward to sharing detailed safety data from the Phase 1 study later this quarter and to sharing additional updates on the progress of our Phase 2 programs for voriconazole and tacrolimus.

Originally approved as an oral deworming drug by the United States Food and Drug Administration in 1982, niclosamide has recently been shown to exhibit potent antiviral activity against SARS-CoV-21 but has limited water solubility as well as poor absorption and bioavailability when administered orally. TFF Pharmaceuticals intends to use 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 limits of systemic administration. TFF has already completed a preclinical study live efficacy study that showed a seven-fold reduction in lung viral load in a hamster model when dry powder niclosamide was given 24 hours after SARS-CoV-2 inoculation 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 who will receive the active drug and two who will receive a placebo, while the MAD phase consisted of doses of 3.0 and 6.0 mg given twice daily (BID) for 4.5 days (9 doses in total). The Safety Management Committee had no questions or concerns regarding safety and recommended the daily dose of 6.0 mg BID (12 mg total daily dose) as safe for progression to phase testing 2.

“As highly contagious and evasive variants of SARS-CoV-2 continue to emerge, along with new restrictions on access to certain therapies previously available under emergency use authorization, there are a continued need for accessible antiviral treatments that can be administered on an outpatient basis,” said Dale Christensen, Ph.D., clinical development manager at TFF Pharmaceuticals. ‘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 cellular pathways rather than the SARS-CoV-2 virus itself, so it is unaffected by spike protein mutations and could theoretically work against any emerging variant. We are excited to report more comprehensive safety results and look forward to working with our partner to advance into late-stage studies with the recommended dose. »

Following the results of the phase 1 trial, UNION Therapeutics A/S has the 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 suitable for generating dry powder particles with targeted properties for administration by inhalation, especially in the deep lungs, an area of ​​extreme interest for respiratory medicine. The TFF process results in a “brittle matrix particle”, which has a low bulk density, high surface area, and generally an amorphous morphology, allowing the particles to supersaturate when they come into contact with the target site, such as lung tissue. Based on laboratory experiments, the aerodynamic properties of the particles are such that the portion of a drug deposited in the deep lungs has the potential to reach up to 75%.

About TFF Pharmaceuticals
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative pharmaceutical 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 drug class that comprises approximately one-third of the world’s leading pharmaceuticals, thereby improving their pharmacokinetics. TFF Pharmaceuticals has two lead drug candidates: voriconazole inhalation powder and tacrolimus inhalation powder. The Company plans to complete this pipeline by collaborating with major pharmaceutical partners. The TFF platform is protected by 42 patents issued or pending in the United States and around the world. 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 specializing in immunology and infectious diseases. The company is currently working with two complementary chemistry classes, covering immunology and microbiology with six programs in clinical development. UNION is headquartered in Hellerup, Denmark, and is led by an international team of biotech entrepreneurs and senior pharma executives with experience in the development and launch of more than fifteen marketed drugs. To learn more, visit 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, as well as the company’s plans to add to its existing pipeline of product candidates. These forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. These factors include: (i) the risk that the Company may not be able to successfully conclude clinical trials or obtain pre-marketing approval for its dry powder version of niclosamide, (ii ) assuming the Company is successful in its clinical trials of niclosamide, that the Company will be able to enter into a licensing agreement with UNION on terms favorable to the Company, if any, (iii) any drug products incorporating the TFF platform n has received pre-market approval from the FDA or has otherwise been incorporated into a commercial drug, (iv) the Company has no current agreements or understandings with large corporations pharmaceutical companies for the development of a drug incorporating the TFF platform, (v) the risk that the Company may not be able to enter into a long-term commercial agreement with a third party, and (vi) the other risks disclosed in the “Risk Factors” section 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 forward-looking statements. TFF Pharmaceuticals does not undertake and specifically disclaims any obligation to update or revise these statements to reflect new circumstances or unforeseen events as they occur, except as required by law.

Contact with Investor Relations:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
[email protected]

Media Contact:
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
[email protected]

Source: TFF Pharmaceuticals, Inc.

  1. Identification of SARS-CoV-2 antiviral drug candidates 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 powder for inhalation manufactured by thin layer freezing: tolerance and multidose 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

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