TFF Pharmaceuticals Announces Completion of Dosing of Phase 1b Study for Voriconazole Inhalation Powder in Mild to Moderate Asthma Patients

Initial data from Phase 1b showed Voriconazole Inhalation Powder is Well Tolerated in Asthma Patients

Data Supports Progress to Phase 2 and Inclusion of Patients with Asthma

AUSTIN, Texas, Nov. 08, 2021 (GLOBE NEWSWIRE) — 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 dosing in the Phase 1b clinical trial of Voriconazole Inhalation Powder (TFF VORI), a next-generation, direct-to-lung, inhaled dry powder version of voriconazole for the treatment and prevention of Invasive Pulmonary Aspergillosis (IPA) (NCT #04576325). This study assessed the safety and tolerability of patients with mild to moderate asthma, a population at high risk of developing IPA, in two cohorts of eight patients. Initial data from the study suggests that TFF VORI is well tolerated in asthma patients, supporting the Company’s progress to Phase 2 study in IPA patients.

To date, observational data from this trial support the inclusion of patients that have hyperreactive airway disease comorbidities in the Phase 2 trial. This suggests TFF VORI also may have the potential to treat Allergic Bronchopulmonary Aspergillosis (ABPA) indication which impacts up to 2.5%¹ of asthma patients.

“We are pleased to have reached another important clinical milestone in our Inhaled Voriconazole program,” said Glenn Mattes, President and CEO of TFF Pharmaceuticals. “By assessing asthma patients in this Phase 1b reactive airway, we hope to demonstrate that our Voriconazole Inhalation Powder would allow for treatment of patients with IPA that have hyperreactive airway disease comorbidities. We look forward to providing specific data from this trial later in the year.”

Patients with asthma and a portion of patients with cystic fibrosis and chronic obstructive pulmonary disease (COPD) are susceptible to IPA infections due to impaired mucociliary clearance but have hyperreactive airways where bronchoconstriction can be triggered following administration of drugs by inhalation.

Professor Associate Carsten Schwarz, MD, Director of the Cystic Fibrosis Center in Potsdam Germany said, “By delivering Voriconazole directly to the site of infection, TFF VORI offers the potential for treatment of IPA patients that could be both safer and more effective than the current formulation. It could also be used as a prophylactic to prevent IPA in at risk populations. I am encouraged to see that TFF VORI has the potential to be a viable treatment option in patients with hyperreactive airways, and I look forward to taking part in the upcoming Phase 2 study of this important drug.”

Drugs for treatment of pulmonary infections can be associated with induction of bronchospasm and require bronchodilator pretreatment for safe administration. Previous studies of approved inhaled antibacterial drugs like amikacin have shown that up to 3% of patients (including asthma and non-asthma patients) experience bronchospasm, necessitating a label requirement that patients first receive pretreatment with a short acting bronchodilator prior to administration of the antibiotic.

The observational data from the Phase 1b trial indicates that TFF VORI is well tolerated in asthma patients. 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 associated with significant drug-drug interactions and toxicities. Delivery of voriconazole directly to the lung may allow for a product that has greater efficacy than orally administered voriconazole and that has improved safety through reduced systemic toxicities and reduced drug-drug interactions.

This Phase 1b reactive airway study is a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and induction of bronchospasm of Voriconazole Inhalation Powder (VIP) in 16 patients with mild to moderate asthma patients. There were two cohorts in this study. In cohort 1, 8 eligible subjects were randomized in a 3:1 ratio (6 on active and 2 on placebo) to receive 7 doses BID over 3.5 days of 40mg VIP or inhaled placebo. In cohort 2, 8 eligible subjects were also randomized in a 3:1 ratio to receive 7 doses BID over 3.5 days of 80 mg VIP or placebo. In both cohorts, doses were administered twice daily every 12 (± 1) hours.

TFF Pharmaceuticals’ proprietary Thin Film Freezing technology platform allows the reformulation of voriconazole into dry powder particles with properties believed to be ideally suited for inhalation delivery. In addition to voriconazole, TFF is also developing dry powder formulations of tacrolimus to prevent lung transplant rejection and niclosamide to treat COVID-19 (SARS-CoV-2) infections.

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 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 tacrolimus der e, 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 and 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 (vi) those other risks disclosed in the section “Risk Factors” included in the Company’s 2020 Annual Report on Form 10-K filed with the SEC on March 10, 2021. 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.

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 Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com 

Media Contact:
Gwendolyn Schanker
LifeSci Communications
(269) 921-3607
gschanker@lifescicomms.com 

Source: TFF Pharmaceuticals, Inc.

¹ 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. doi: 10.3109/13693786.2012.738312. Epub 2012 Dec 4. PMID: 23210682. Accessed November 5, 2021.