Press Release

TFF Pharmaceuticals Updates Progress of Human Clinical Trial with Tacrolimus Inhalation Powder

October 20, 2020 at 9:00 AM EDT

Company completes dosing of three cohorts with Tacrolimus Inhalation Powder for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection

Single ascending dose cohorts to date shown to be safe with no clinically significant drug-associated adverse events, while achieving substantial immunosuppressive blood levels

AUSTIN, Texas--(BUSINESS WIRE)--Oct. 20, 2020-- 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 successfully completed the single ascending dosing of three cohorts of healthy subjects for its second clinical program, Tacrolimus Inhalation Powder for the prevention of lung transplant rejection.

This Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study will assess the safety, tolerability and pharmacokinetics of tacrolimus, an important immunosuppressive agent for the prophylactic treatment of lung transplant rejection. Subjects were dosed at a single site in Australia under the Australian Clinical Trial notification (CTN) process.

In June 2020, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection. The ongoing Phase 1 clinical trial of Tacrolimus Inhalation Powder is a randomized, double-blind, placebo-controlled study with an inhalation route of administration to 64 healthy adult volunteers. The study is comprised of two dose escalation phases – a SAD phase with 40 participants, followed by a MAD phase with 24 participants. For the MAD phase, subjects will receive a total of 13 doses over 7 days with doses being administered every 12 hours. The main objectives of the Phase 1 clinical trial are to assess the safety, tolerability and pharmacokinetic profile of the Tacrolimus Inhalation Powder in healthy subjects.

The Company reports that dosing in the first three cohorts of healthy normal volunteers in the SAD phase of the study were shown to be safe and well tolerated with no reports of clinically significant drug-associated adverse events. Successful completion of the third cohort of the SAD part of the study with no reported safety concerns represents a critical milestone for progression of the study. The final safety data from all five cohorts in the SAD portion of the study will be used to commence the MAD portion of the trial, with dosing of the first cohort in the MAD phase to be initiated soon.

“We are pleased to report this important progress in our second clinical development program and are excited to see that the dosing completed to date suggests that Tacrolimus Inhalation Powder can be safely administered and provide substantial systemic blood levels, from just a single dose, that approach those levels associated with effective immunosuppression in heart, lung, kidney and liver transplant patients,” stated Glenn Mattes, President and CEO of TFF Pharmaceuticals. “The ability to safely delivery tacrolimus by a route that bypasses the gastrointestinal tract could provide for fewer drug-to-drug interactions and could provide for more predictable drug levels, because poor bioavailability and differential metabolism can lead to highly variable drug levels with orally delivered tacrolimus.”

“We believe these data indicate that TFF Tacrolimus has strong potential in not only the current lung transplant indication, but also potential efficacy, safety and survival benefits for heart, liver and kidney transplant patients,” concluded Mattes.

TFF Pharmaceuticals’ proprietary Thin Film Freezing technology platform allows the reformulation of Tacrolimus into dry powder particles with properties believed to be ideally suited for inhalation delivery. The Tacrolimus dry powder formulation is currently being developed to prevent lung transplant rejection and if the pharmacokinetics from the ongoing trial indicate that pulmonary delivery provides more predictable blood levels than oral dosing, the Company may pursue developments to prevent rejection in other solid organ transplant procedures.

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.

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 Voriconazole and Tacrolimus 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 results obtained in preclinical studies and clinical trials may not be indicative of results obtained in future clinical trials; (ii) the risk that the Company’s product candidates may not advance through the preclinical development and clinical trial process on a timely basis, or at all; (iii) the risk that the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; (iv) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its dry powder versions of Voriconazole and Tacrolimus, (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vii) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (viii) those other risks disclosed in the section “Risk Factors” included in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 26, 2020. 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.

Company Contacts:

Glenn Mattes
President and CEO
TFF Pharmaceuticals, Inc.
gmattes@tffpharma.com
737-802-1973

Kirk Coleman
Chief Financial Officer
TFF Pharmaceuticals, Inc.
kcoleman@tffpharma.com
817-989-6358

Investor Relations and Media Contact:
Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779

Source: TFF Pharmaceuticals, Inc.

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