FORT WORTH, Texas, Nov. 01, 2022 (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 program updates for Voriconazole Inhaled Powder (TFF VORI) and Tacrolimus Inhaled Powder (TFF TAC) clinical programs.
We expect to deliver preliminary patient data from the Phase 2 study of TFF VORI in the first quarter of 2023 and TFF TAC in the second quarter of 2023. These Phase 2 studies are expected to provide safety, tolerability, and efficacy data. The timing of data release has been updated due to several challenges related to staffing shortages, shipping, and global supply chain delays. We continue to work diligently to overcome these challenges.
Specifically, we are working with our CRO to solidify our assigned team as they are working through an integration process following a merger. We have taken a hands-on approach to assist our clinical sites that have managed issues related to staffing shortages within the healthcare system. Additional sites are being added to accelerate enrollment. We have been diligently working with our CRO and regulatory agencies that have also been managing through staffing shortages to obtain country-specific regulatory and ethics study approvals for all clinical sites. We have addressed protracted global supply chain issues that impeded the acquisition of the comparator drug for the TFF VORI trial.
“Clinical trial operations and logistics for much of the pharmaceutical industry, including TFF, continue to be impacted by ongoing staffing shortages and global supply chain constraints, which have subsequently led to challenges in predicting enrollment and data readouts,” said Glenn Mattes, Chief Executive Officer of TFF Pharmaceuticals. “We continue to believe in the value creation of our internal pipeline. As announced today, we believe the positive results from a second patient in our compassionate use program of TFF VORI demonstrate how Thin Film Freezing can be applied to deliver potentially life-saving medicine in a more targeted, safer manner to patients. We are addressing the outstanding issues and have factored their impact into our current guidance for the TFF VORI and TFF TAC programs, and will provide further updates as appropriate.”
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING TECHNOLOGY PLATFORM
TFF Pharmaceuticals’ proprietary Thin Film Freezing (TFF) technology allows for the transformation of both existing compounds and new chemical entities into dry powder formulations exhibiting unique characteristics and benefits. The Thin Film Freezing process is a particle engineering process designed to generate dry powder particles with advantageous properties for inhalation, as well as parenteral, nasal, oral, topical and ocular routes of administration. The process can be used to engineer powders for direct delivery to the site of need, circumventing challenges of systemic administration and leading to improved bioavailability, faster onset of action, and improved safety and efficacy. The ability to deliver therapies directly to the target organ, such as the lung, allows TFF powders to be administered at lower doses compared to oral drugs, reducing unwanted toxicities and side effects. Laboratory data suggests the aerodynamic properties of the powders created by Thin Film Freezing can deliver as much as 75% of the dose to the deep lung. Thin Film Freezing does not introduce heat, shear stress, or other forces that can damage more complex therapeutic components, such as fragile biologics, and instead enables the reformulation of these materials into easily stored and temperature-stable dry powders, making therapeutics and vaccines more accessible for distribution worldwide. The advantages of Thin Film Freezing can be used to enhance traditional delivery or combined to enable next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaging patented rapid freezing technology to develop and transform medicines into potent dry powder formulations for better efficacy, safety, and stability. The company’s versatile Thin Film Freezing (TFF) technology platform has broad applicability to convert most any drug, including vaccines, small and large molecules, and biologics, into an elegant dry powder highly advantageous for inhalation, with improved absorption so drugs can also be delivered to the eyes, nose and topically to the skin. TFF has two lead drug candidates in the clinic: Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder and continues to expand its pipeline by collaborating with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by 120+ patents issued or pending in the U.S. and internationally. To learn more about TFF Pharmaceuticals and its product candidates, visit the Company’s website at https://tffpharma.com.
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the expectations for its continued development of Voriconazole Inhalation Powder, Tacrolimus Inhalation Powder, the benefits of the Company’s TFF platform 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 realize its timeline for the receipt of patient data from the Phase 2 studies of TFF VORI and TFF TAC, (ii) the risk that the Company may not be able to successfully conclude clinical testing or obtain pre-market approval of its TFF VORI, TFF TAC or any of its other dry powder product candidates, (iii) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (iv) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (v) 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 2021 Annual Report on Form 10-K filed with the SEC on March 24, 2022. 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.
Investor Relations Contact:
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Raena Mina, Ph.D.