TFF Pharmaceuticals Announces Initiation of Phase 1 Clinical Trial of Voriconazole Inhalation Powder, to Treat Invasive Pulmonary Aspergillosis (IPA)

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

AUSTIN, Texas–(BUSINESS WIRE)–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 Phase 1 clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of Voriconazole, generally considered to be the most effective antifungal drug for treating Invasive Pulmonary Aspergillosis (IPA). The trial will initiate dosing of patients this week and be 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.

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 Jay Peters, M.D., Professor and Chief of Pulmonary and Critical Care at the University of Texas Health Science Center in San Antonio, Texas. “The initiation of the first human dosing, administered directly to the lung, is a significant step forward in developing 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.”

“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 Glenn Mattes, President and CEO of TFF Pharmaceuticals. “This is a key milestone for our company and further validation of the viability and innovation of our patented TFF technology. We are committed to developing new drugs with potentially numerous commercial applications for chronic respiratory diseases and lung conditions, as well as other non-lung related diseases.”

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.

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 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 prospectus dated October 24, 2019 filed with the SEC on October 25, 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.

Reference:

1. 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; Sep 15, 2004.
2. Limper AH, et al. An official American Thoracic Society statement: treatment of fungal infections in adult pulmonary and critical care patients. Am J Respir Crit Care Med. 2011;183:96–128.
3. Walsh TJ, Anaissie EJ, Denning DW, et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008;46:327-360.
4. Kousha M, Tadi R, Soubani AO. Pulmonary aspergillosis: a clinical review. Eur Respir Rev. 2011;20:156-174.
5. Ashutossh Naaraayan, 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
6. 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.

Contacts

Company:
Glenn Mattes

President and CEO

TFF Pharmaceuticals, Inc.

[email protected]
737-802-1973

Kirk Coleman

Chief Financial Officer

TFF Pharmaceuticals, Inc.

[email protected]
817-989-6358

Investor Relations and Media:
Paul Sagan

LaVoieHealthScience

[email protected]
617-953-4779