Successfully completes single ascending dose phase of first clinical study in healthy subjects for a direct-to-lung, Thin Film Freezing (TFF) dry-powder formulation
Invasive Pulmonary Aspergillosis is a severe fungal pulmonary disease with a mortality rate that can reach 90 percent¹ in some patient populations
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 completion of the single ascending dose (SAD) portion and enrollment into the multiple ascending dose (MAD) 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 trial is being 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 64 healthy subjects.
The Company successfully completed all four dose-escalation cohorts of the single ascending dose phase of the trial. Enrollment of the first cohort in the multiple ascending dose (MAD) portion of the study has also been completed and the Data Safety Monitoring Board (DSMB) has approved escalation to the next dose level.
"The Voriconazole Inhalation Powder has been well tolerated in the SAD dose escalation phase and we look forward to escalating the dose in the MAD portion of the study," said Glenn Mattes, President and CEO of TFF Pharmaceuticals. "This is an important step in our clinical progress to date for what we believe will be an important new drug for critically ill patients that suffer from IPA. Inhaled Voriconazole also has significant potential to aid in the treatment of allergic bronchopulmonary aspergillosis (ABPA) – a condition predominately in asthmatics where the fungus Aspergillus induces a hypersensitivity response."
The Phase I clinical trial of Voriconazole Inhalation Powder is a randomized, double-blind, placebo-controlled study with inhalation route of administration to 64 healthy adult volunteers. The study is comprised of a dose escalation phase - SAD followed by MAD study with 32 participants in each stage. For the MAD study, 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.
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.
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 39 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.
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the benefits of the Company’s TFF platform and its dry powder version of Voriconazole 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) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (ii) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform and (iii) those other risks disclosed in the section "Risk Factors" included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on December 9, 2019. 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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