TFF Pharmaceuticals Announces Phase 1 Clinical Trial Progress for Voriconazole Inhalation Powder to Treat Invasive Pulmonary ...
March 19 2020 - 8:00AM
Business Wire
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.
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 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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version on businesswire.com: https://www.businesswire.com/news/home/20200319005353/en/
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
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