TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial

Patients with asthma, and a portion of patients with Cystic Fibrosis and Chronic Obstructive Pulmonary Disease (COPD), have hyperreactive airways where bronchoconstriction can be triggered following administration of drugs by inhalation. These patient populations are also susceptible to Invasive Pulmonary Aspergillosis infections due to impaired mucociliary clearance, which allows aspergillus spores to become trapped and grow in mucus that builds up in their lungs.

TFF Pharmaceuticals is conducting this Phase 1b clinical trial of Voriconazole Inhalation Powder in patients with asthma to assess the safety, pharmacokinetics, and induction of bronchospasm. Drugs for treatment of pulmonary infections can be associated with induction of bronchospasm and require bronchodilator pretreatment for safe administration. Treatment of Voriconazole Inhalation Powder without induction of bronchospasm would allow for treatment of patients with IPA that have hyperreactive airway disease comorbidities to proceed without bronchodilator pretreatment.

“The treatment of asthma patients in this study will test the safety and pharmacokinetics in patients with airway hyperresponsiveness, and will expand the potential patient population to help speed enrollment in our pivotal trials for the treatment of IPA with Voriconazole Inhalation Powder,” stated Glenn Mattes, President and CEO of TFF Pharmaceuticals. “This study will also help us determine if there are differences in drug uptake in patients with compromised lungs, compared to healthy subjects.”

TFF Pharmaceuticals is advancing development of Voriconazole Inhalation Powder towards a pivotal Phase 2 study to assess the efficacy of the dry powder formulation for the treatment of IPA. Previously, TFF reported that repeated dosing of Voriconazole Inhalation Powder twice daily for 7 days in healthy normal volunteers was well tolerated at doses up to 80 mg with no clinically significant adverse findings, including changes in pulmonary function. The current study is designed to assess the safety and tolerability of 40 and 80 mg doses in asthma patients with hyperreactive airways. Administration of the inhaled voriconazole to IPA patients at 40 mg doses was previously reported to be well tolerated.

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.

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-CoV2) 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 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, (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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