Phase 1 clinical study report for Voriconazole
Inhalation Powder indicated no treatment emergent adverse events at
peak plasma levels for Invasive Pulmonary Aspergillosis
Phase 1 Single Ascending Dose study of
Tacrolimus Inhalation Powder met and exceeded therapeutic drug
levels with a single dose with no significant adverse events
reported
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 provided an update on the clinical
development progress of its Voriconazole Inhalation Powder and
Tacrolimus Inhalation Powder products.
Voriconazole Inhalation Powder
The Phase 1 clinical trial of Voriconazole Inhalation Powder for
the treatment of invasive pulmonary aspergillosis (IPA), an inhaled
dry powder version of voriconazole, has been successfully completed
and comprehensive safety and pharmacokinetic data is now available
following delivery of the clinical study report. Voriconazole is
recommended as the first line treatment for IPA according to the
Infectious Disease Society (IDSA) - Practice Guidelines for the
Diagnosis and Management of Aspergillosis (2016), but voriconazole
is also associated with significant drug-drug interactions and
toxicities.
Through completion of the Single Ascending Dose (SAD) and
Multiple Ascending Dose (MAD) cohorts, TFF demonstrated that doses
of 10, 20, 40, and 80 mg could be delivered twice daily using a dry
powder inhaler device with no significant adverse events. There was
no evidence of treatment-related or dose-related trends in the
reporting of treatment emergent adverse events, throughout the
study. No subjects experienced any dose limiting toxicity events
during the study.
“This Phase 1 clinical trial safety data has dramatically
exceeded our expectations for Voriconazole Inhalation Powder,”
stated Glenn Mattes President and CEO of TFF Pharmaceuticals, “The
ability to reach blood levels greater than two-fold higher than
those shown to clear complex IPA infections provides confidence
that dosing patients with the 80 mg dose has a high probability of
efficacy without adverse events, and could establish our product as
the leading therapy for IPA.”
Voriconazole Inhalation Powder is being developed by TFF to
treat IPA with the goal of enhancing efficacy through more
efficient delivery of the drug to the lung relative to the oral or
intravenous forms of Vfend®, where blood levels can reach greater
than 5,000 ng/mL in order to deliver sufficient voriconazole to the
lung. However, drug levels greater than 5,000 ng/mL in the blood
are associated with severe adverse events including liver kidney
and visual toxicities.
Evaluation of the pharmacokinetic profile of the Voriconazole
Inhalation Powder demonstrated that mean peak plasma voriconazole
levels reached concentrations of 227 ng/mL following repeated
dosing at 80 mg twice daily for 7 days, without any reports of
adverse events.
“Now that we have the final data from this Phase I trial, we
have confidently selected the 80 mg dose of Voriconazole Inhalation
Powder for our upcoming pivotal trial, where we will be comparing
it to the oral form of voriconazole,” said Mattes. “We expect to
continue to see a more favorable adverse events profile in the
inhalable arm, and equal to or greater efficacy when compared to
oral voriconazole.”
“We’re excited for the future development of Voriconazole
Inhalation Powder because we feel it can achieve our target product
profile of having better efficacy than oral voriconazole by
delivering a greater amount of drug directly to the site of the
infection, and of having fewer adverse effects than voriconazole
that is dosed systemically to achieve drug levels able to reach the
lung,” said Mattes.
In addition to the release of the final data from the Phase 1
clinical trial, TFF is continuing to enroll asthma patients in a
Phase 1b study to understand if the Voriconazole Inhalation Powder
is likely to trigger bronchospasm in patients with hyperreactive
airway disease. Other inhaled anti-infective drugs have
demonstrated this effect and require pretreatment with a
bronchodilator prior to dosing. TFF is completing this reactive
airway study to guide the clinical practice in patients with
hyperreactive airway diseases (Asthma and COPD). The data from this
study and from the completed healthy normal Phase 1 study will lead
to the initiation of a pivotal study of Voriconazole Inhalation
Powder, which will begin enrolling patients later this year.
Tacrolimus Inhalation Powder
TFF Pharmaceuticals also reports that dosing of the Single
Ascending Dose portion of the Phase 1 study of Tacrolimus
Inhalation Powder has been successfully completed and the Multiple
Ascending Dose portion is ongoing. The SAD portion of the study
indicated that TFF’s Tacrolimus Inhalation Powder was able to reach
therapeutic blood levels of 5-16 ng/mL in all patients from a
single inhaled dose of 5 mg of Tacrolimus Inhalation Powder,
without significant adverse events.
“The ability to efficiently reach therapeutic drug levels with
our Tacrolimus Inhalation Powder following just a single dose
without any significant adverse events is very significant and
ahead of our expectations,” said Mattes. “Achieving therapeutic
blood levels efficiently, with low doses of the inhaled powder,
suggests that our product may have application beyond lung
transplant, potentially in heart, kidney and liver transplant
patients.”
In clinical practice, tacrolimus blood levels are monitored and
controlled to achieve blood levels that are known to be associated
with efficacious immunosuppression, while not elevating the blood
concentration to levels associated with toxicities. For lung
transplant patients, therapeutic drug monitoring (TDM) is used to
achieve maintenance tacrolimus levels from 5-15 ng/mL after
transplant to prevent acute allograft rejection1. The Phase 1 study
of Tacrolimus Inhalation Powder utilized TDM measurements to
determine when a sufficient dose level had been reached.
“We look forward to the additional safety and pharmacokinetic
data that will be produced during the dosing of the remaining MAD
cohorts as we complete this study and prepare for pivotal trials of
this promising therapy,” concluded Mattes. “We expect to have final
safety data completed by the end of the second quarter of 2021,
enabling us to move into the pivotal trial phase in the second half
of the year.”
1
Immunosuppression in lung
transplantation
Jenna L. Scheffert, Kashif Raza
J Thorac Dis. 2014 Aug; 6(8): 1039–1053.
doi: 10.3978/j.issn.2072-1439.2014.04.23
PMCID: PMC4133546
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 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 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 or 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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version on businesswire.com: https://www.businesswire.com/news/home/20210304005584/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 617-865-0041
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