First clinical study in healthy subjects of 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’ 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 and has the potential to be the first dry powder inhaled fungicide on the market.
“Preclinical data generated from early animal testing with the TFF technology platform supports the development of Voriconazole Inhalation Powder for the treatment of IPA,” said
“TFF Pharmaceuticals has been able to rapidly progress from research, to product formulation, to clinical trial study for our lead drug candidate, Voriconazole Inhalation Powder,” said
The Phase I clinical trial 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 – a single ascending dose (SAD) followed by multiple ascending dose (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.
About Pulmonary Fungal Infections
Lung fungal infections are a critical health problem, particularly in immune-compromised populations. With increasing numbers of immune-compromised patients with malignancy, hematologic disease, and HIV, as well as those receiving immune suppressive drug regimens, the incidence of fungal infections has dramatically increased in recent years.2
Aspergillus is an opportunistic mold causing pulmonary infections, commonly found in soil, food, plant debris, and some indoor environments. The spores of Aspergillus are easily aerosolized and inhaled, and in the respiratory mucosa, the spores may germinate into hyphae, which in turn can invade the mucosa leading to invasive pulmonary aspergillosis (IPA).
Invasive pulmonary aspergillosis is a severe fungal infection that usually occurs in severely immunocompromised patients and is a significant cause of morbidity and mortality in that patient population.3 4 Diagnosis is challenging due to the non-specific nature of symptoms. Voriconazole is the mainstay of therapy.5
Allergic bronchopulmonary aspergillosis (ABPA) is a hypersensitivity reaction to Aspergillus that occurs almost exclusively in patients with asthma or cystic fibrosis. Allergic bronchopulmonary aspergillosis likely affects between 1 and 15% of cystic fibrosis patients, and 2.5% of adults who have asthma also have ABPA, or approximately 4.8 million people worldwide.6
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 on 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.
This press release contains forward-looking statements regarding
Meersseman W, Vandecasteele SJ, Wilmer A, Verbeken E, Peetermans WE, Van Wijngaerden E. Invasive aspergillosis in critically ill patients without malignancy. Volume 170(6):621-5;
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Walsh TJ, Anaissie EJ, Denning DW, et al. Treatment of aspergillosis: clinical practice guidelines of the
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- Kousha M, Tadi R, Soubani AO. Pulmonary aspergillosis: a clinical review. Eur Respir Rev. 2011;20:156-174.
Ronak Kavian, Jeffrey Lederman, Prasanta Basak& Stephen Jesmajian(2015) Invasive pulmonary aspergillosis – case report and review of literature, Journal of Community Hospital Internal Medicine Perspectives, 5:1, DOI: 10.3402/jchimp.v5.26322
- Denning DW, Pleuvry A, Cole DC. Global burden of allergic bronchopulmonary aspergillosis with asthma and its complication chronic pulmonary aspergillosis in adults. Med Mycol. 2013 May;51(4):361-70.
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TFF Pharmaceuticals, Inc.
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