Press Release

TFF Pharmaceuticals Announces First Human Dosing With Tacrolimus Inhalation Powder and Topline Data for Voriconazole Inhalation Powder

June 29, 2020 at 9:00 AM EDT

First dosing of Tacrolimus Inhalation Powder initiates development program for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection

Phase 1 topline data indicates safety of single doses of Voriconazole Inhalation Powder up to 80 mg/dose in healthy subjects for direct-to-lung delivery of voriconazole for Invasive Pulmonary Aspergillosis

AUSTIN, Texas--(BUSINESS WIRE)--Jun. 29, 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 the initiation of its second clinical trial program with the dosing of healthy subjects with Tacrolimus Inhalation Powder. 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 CTN process.

The Company also announced topline safety data from the single ascending dose portion of its Phase 1 clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of Voriconazole. Voriconazole is generally considered to be the most effective antifungal drug for treating Invasive Pulmonary Aspergillosis (IPA).

The Company reports that doses of up to 80 mg/dose in healthy normal volunteers were shown to be safe and well tolerated with no clinically significant drug-associated adverse events, including nephrotoxicity or visual disturbances, which are dose limiting when Voriconazole is administered by oral or intravenous routes. Previously, case reports documented that patients receiving a 40 mg dose of Voriconazole by direct-to-lung inhalation twice daily, when the commercial IV solution was administered using a nebulizer, showed clearance of IPA infections.

The single ascending dose phase of this trial was conducted at a site in Canada for purposes of evaluating, under a U.S. IND and Canadian CTA, the safety, tolerability and pharmacokinetic profile of Voriconazole Inhalation Powder in 32 healthy subjects. Enrollment into the multiple ascending dose (MAD) portion of the study is ongoing and dosing of three of the four planned cohorts has been completed.

“The receipt of positive topline safety data for our Voriconazole Inhalation Powder drug and the start of Phase 1 patient dosing for Tacrolimus Inhalation Powder, despite the ongoing challenges posed by the COVID-19 pandemic, are two very significant milestones for our clinical program and a testament to our determined clinical and scientific staff,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “Voriconazole Inhalation Powder appeared to be safe at doses of up to two times higher than those reported to be efficacious in treatment of IPA. And the start of our Phase 1 trial of Tacrolimus Inhalation powder further demonstrates the potential of direct-to-lung delivery of our Thin Film Freezing (TFF) dry-powder technology.”

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 is 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 will receive 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.

The Phase I 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 a dose escalation phase – a SAD followed by a MAD with 40 participants in the SAD phase and 24 participants in the MAD phase. 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 I clinical trial are to assess the safety, tolerability and pharmacokinetic profile of the Tacrolimus Inhalation Powder in healthy subjects.

In June, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to Tacrolimus Inhalation Powder for prophylaxis of lung allograft rejection.

TFF Pharmaceuticals’ proprietary Thin Film Freezing technology platform allows the reformulation of liquid Voriconazole into dry powder particles with properties believed to be ideally suited for inhalation delivery. The Voriconazole dry powder formulation directly targets the site of the fungal infection in the lung while the Tacrolimus dry powder formulation is being developed to prevent lung transplant rejection.

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.

Company:
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:
Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779

Source: TFF Pharmaceuticals, Inc.

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