TFF Pharmaceuticals Announces Completion of Dosing for Voriconazole Inhalation Powder Phase 1 Clinical Trial

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 the last subject in the multiple ascending dose (MAD) portion of its Phase 1 clinical trial of Voriconazole Inhalation Powder completed their last clinic visit, following repeated dosing. Voriconazole Inhalation Powder is a next-generation, direct-to-lung, inhaled dry powder version of Voriconazole, generally considered to be the most effective antifungal drug for treating Invasive Pulmonary Aspergillosis (IPA).

The Company reports that repeated doses of up to 80 mg/dose twice daily for 7-days in healthy normal volunteers was well tolerated. This completes the clinical portion of the Phase 1 trial with both single ascending dose (SAD) and MAD phases with 32 healthy subjects enrolled in each part to evaluate the safety, tolerability and pharmacokinetic profile of Voriconazole Inhalation Powder. Previously, TFF released topline data from the single ascending dose portion of the study and showed that single doses of 80 mg were safe.

“The successful finalization of dosing and clinic visits is an important milestone for TFF in the Phase 1 trial of our lead development program,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “We are very pleased to have treated subjects with Voriconazole Inhalation Powder with repeated doses that appeared to be well tolerated, particularly at levels of up to two times higher than those typically reported to be efficacious in treatment of IPA. We look forward to the completion and reporting of pharmacokinetic and data analysis in the near future.”

The Phase I clinical trial of Voriconazole Inhalation Powder is a randomized, double-blind, placebo-controlled study with an inhalation route of administration to 64 healthy adult volunteers. The study was comprised of a dose escalation phase – a SAD phase followed by a MAD phase with 32 participants in each stage. For the MAD phase, subjects received a total of 13 doses over 7 days with doses being administered every 12 hours. The main objectives of the Phase I clinical trial are to assess the safety, tolerability and pharmacokinetic profile of the Voriconazole Inhalation Powder in healthy subjects.

TFF Pharmaceuticals’ proprietary Thin Film Freezing technology platform allows the reformulation of Voriconazole into dry powder particles with properties believed to be ideally suited for inhalation delivery to directly target the site of the fungal infection in the lung.

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 Tac-Lac Inhalation Powder. The Company plans to add to this pipeline by collaborating with large pharmaceutical partners. The TFF Platform is protected by 41 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 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, (ii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (iv) the risk that the Company will not be able to conclude a long-term commercial agreement with any third-party, and (v) 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.

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