FORT WORTH, Texas — TFF Pharmaceuticals, Inc. 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 positive initial data from the Company’s ongoing Phase 2 trial of TFF VORI along with clinical data from the ongoing TFF VORI Expanded Access Program (EAP).
“Today is truly a remarkable moment in the history of TFF Pharmaceuticals, as these initial clinical data clearly demonstrate the efficacy and favorable safety and tolerability of TFF VORI in a rare disease indications with high unmet medical need. These compelling results also demonstrate the successful clinical application of our ground-breaking technology platform,” said Harlan Weisman, M.D., President and Chief Executive Officer of TFF Pharmaceuticals. “Based on these highly encouraging efficacy and safety data, we have made the decision to accelerate the development of TFF VORI into registration-enabling studies, given the unequivocally positive results from these initial data. Looking ahead, we expect to present additional clinical data in the first quarter of 2024 to further support the advancement of TFF VORI into registration-enabling studies.”
“These initial data provide compelling evidence that TFF VORI has game-changing potential in the treatment of its rare disease indication, IPA and prevention of rejection after lung transplantation,” said Zamaneh Mikhak, M.D., Chief Medical Officer of TFF Pharmaceuticals. “With respect to TFF VORI, the initial data from the Phase 2 trial and our EAP clearly demonstrate a positively differentiated safety and tolerability profile from the standard-of-care, first-line therapy, oral voriconazole, based on the available historical data. The efficacy results are equally remarkable with treatment response seen in all patients.
TFF VORI – initial Phase 2 and EAP data
The ongoing Phase 2 trial of TFF VORI is an open-label, randomized (3:1) study evaluating treatment with TFF VORI versus oral voriconazole over a 13-week period in patients with IPA. Trial endpoints include safety, tolerability, clinical response, mycologic response, radiologic response, and all-cause mortality. The initial efficacy data presented below include patients from the Phase 2 trial and the Company’s EAP who received at least 8 weeks of therapy with either TFF VORI (N=5) or oral voriconazole (N=1). Safety data included all TFF VORI-treated patients (N=7) and oral voriconazole-treated patients (N=2). Of note, three of the five patients who were treated with TFF VORI for at least 8 weeks had a diagnosis of chronic lung allograft dysfunction (CLAD), which is a lung disease caused by chronic rejection, from the immune system attacking the transplanted lungs. CLAD is a significant cause of morbidity and mortality after lung transplantation and can be exacerbated by infections, further deteriorating the patient’s condition. The patient treated with oral voriconazole for at least 8 weeks did not present with CLAD.
Efficacy
- Of the five patients treated for at least 8 weeks with TFF VORI:
- All five patients achieved a clinical response
- All five patients achieved a mycologic response
- Three of four patients with pre- and post-treatment chest CT achieved a radiologic response
- No need for continued anti-fungal use after treatment with TFF VORI in all five patients
Safety
- No all-cause mortality
- No IPA-related mortality
- No TFF VORI discontinuation due to an AE
- Majority of treatment emergent adverse events (TEAEs) deemed unrelated to TFF VORI
- Majority of TEAEs were Grade 2 or lower in severity
- No hepatic toxicity
- No visual disturbances
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY
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 TFF 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 TFF can deliver as much as 75% of the dose to the deep lung. TFF 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 TFF 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 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, or for topical delivery to the eyes, nose and the skin. TFF Pharmaceuticals has two lead drug candidates in the clinic: TFF VORI (Voriconazole Inhalation Powder) and TFF TAC (Tacrolimus Inhalation Powder). The Company continues collaborations with a broad array of pharmaceutical companies, academic institutions, and government partners to revolutionize healthcare around the globe. The TFF Platform is protected by over 170 patents issued or pending in the U.S. and internationally.
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Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
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