Marks the Second Patient to Clinically Benefit from Administration of Voriconazole Inhalation Powder (TFF VORI) Using Thin Film Freezing-Based Technology
Positive Results from First Patient Treated with TFF VORI Recently Presented at the 15th Annual International Congress on Lung Transplantation
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 that a second patient has been successfully treated with TFF Pharmaceuticals’ proprietary Voriconazole Inhalation Powder (“TFF VORI”) through a compassionate use program. This is the second patient to receive TFF VORI at the Alfred Hospital in Melbourne, Australia. In September, Dr. Bradley Gardiner presented data from the first patient successfully treated with TFF VORI at the 15th Annual International Congress on Lung Transplantation.
TFF VORI is a next-generation, direct-to-lung, inhaled dry powder formulation of voriconazole for the treatment and prevention of Invasive Pulmonary Aspergillosis (IPA). TFF’s proprietary Thin Film Freezing technology platform allows for the reformulation of voriconazole into a dry powder with properties ideally suited for inhalation.
During the ongoing compassionate use program, a second lung transplant patient has been successfully treated with TFF VORI. The patient had a history of skin cancers and multiple fungal infections. During the prior treatment for the fungal infections with oral voriconazole and posaconazole, the patient experienced hair loss, fatigue, and an increased QTc interval that required discontinuation of two cardiovascular medications. These are well known side effects associated with the use of oral azole antifungals. After discontinuing a recent course of posaconazole, the patient then experienced progressively increased coughing, shortness of breath, and did not respond to oral antibiotics. The patient was subsequently diagnosed with a pulmonary aspergillus infection and experienced declining lung function. Given the toxicities from prior oral azole antifungal therapy and the preexisting skin cancers, the patient was no longer able to tolerate oral voriconazole or other azole antifungals.
Following initiation of TFF VORI therapy, the patient’s lung function stabilized without additional decreases in Forced Expiratory Volume in one second (FEV1) or FEV1/Forced Vital Capacity (FVC) ratios. Consistent with the first patient who received TFF VORI, no dose modification of tacrolimus was required, which is notable due to the well-known severe drug-drug interactions between tacrolimus and oral voriconazole. The patient has been on TFF VORI therapy for six weeks and has returned negative cultures for aspergillus in recent specimens obtained from bronchoscopic evaluation. These results support the potential safety and efficacy advantages of TFF VORI, which the Company expects to further demonstrate in its Phase 2 study.
“Treatment options for many transplant patients who experience aspergillus fungal infections are often limited due to multiple pre-existing conditions, including skin cancers and intolerance to prior oral voriconazole therapy,” said Dr. Gregory Snell, Medical Head of Lung Transplant Service at the Alfred Hospital. “This is now the second case that we’ve successfully administered this novel inhaled formulation of voriconazole to a lung transplant patient who could no longer tolerate oral voriconazole therapy. I am encouraged by the clinical response in this second patient, and we will conduct additional testing in cases where alternative treatment options may be necessary.”
Dale Christensen, Ph.D., Head of Clinical Development at TFF Pharmaceuticals, added, “It is encouraging to see a second patient respond well to our TFF VORI therapy, which provides further clinical evidence that Thin Film Freezing can impart significant therapeutic benefit after standard of care therapy is no longer a viable option. Results from these first two compassionate use case studies confirm the target product profile of TFF VORI.”
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.
SAFE HARBOR
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 study 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 Voriconazole Inhalation Powder, Tacrolimus Inhalation Powder 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:
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
cdavis@lifesciadvisors.com
Media Contact:
Raena Mina, Ph.D.
LifeSci Communications
rmina@lifescicomms.com
