TFF Pharmaceuticals Makes Available Phase 2 Data from Tacrolimus Inhalation Powder (TFF TAC) for the Prevention of Lung Transplant Rejection Presented at the Recent ISHLT Annual Meeting

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TFF Pharmaceuticals has released Phase 2 data from Tacrolimus Inhalation Powder (TFF TAC) for preventing lung transplant rejection. Results show TFF TAC can prevent rejection at lower doses than oral tacrolimus, reducing systemic exposures and toxicities. Gene expression data indicate TFF TAC normalizes rejection-related genes, potentially improving efficacy and safety post-transplant.

Positive

• TFF Pharmaceuticals presents promising Phase 2 data on TFF TAC for lung transplant rejection prevention

• TFF TAC shows potential to optimize lung immune suppression at lower systemic exposures

• Gene expression data suggest TFF TAC can normalize rejection-related genes, potentially enhancing safety and efficacy post-transplant

Negative

• None.

Biopharmaceutical Analyst

The revelation about TFF Pharmaceuticals' Phase 2 data for TFF TAC, an inhalable form of tacrolimus, is quite telling. This novel approach to preventing lung transplant rejection represents a significant shift in the standard treatment paradigm, which currently relies on oral tacrolimus, a drug known for its efficacy but also its potential for systemic toxicity. The key takeaway here is the reduced dosage requirement of TFF TAC, which is touted to be at one-sixth the oral dose and the associated decline in systemic exposure by one-third. This could potentially translate into fewer side effects for patients, a game changer in post-transplant care. However, investors are to note that whether these results can be replicated on a larger scale and how they will affect market acceptance is not yet clear. The long-term impact on the company's revenue will depend on the outcome of registrational trials and subsequent FDA approval processes.

Medical Research Analyst

Looking at TFF Pharmaceuticals' data from a medical research perspective, the normalization of gene expression related to lung transplant rejection when using TFF TAC is promising. This indicates a targeted approach at the molecular level, which is often the holy grail in drug development. Reduced systemic exposures while maintaining efficacy could considerably lower the risk of complications like nephrotoxicity and hypertension, common with systemic immunosuppressants. However, for investors, it is important to understand the complexities of clinical development. The current data is exciting, but the pending Phase 3 trials will truly be indicative of the drug's future. Moreover, extrapolating the Phase 2 findings to the broader patient population comes with inherent risks and it will be the larger, more diverse Phase 3 trials that will provide a clearer picture of the drug's efficacy and safety profile.

Data Now Available on Company Website Following 8-K Filing

Data Demonstrate that Treatment with TFF TAC Prevents Lung Transplant Rejection at Only One-sixth of the Dose of Oral Tacrolimus and at Two-thirds of the Oral Tacrolimus Systemic Trough Exposures

Gene Expression Biomarker Data Demonstrate that Treatment with TFF TAC Leads to Normalization of Expression of Rejection-Related Genes

FORT WORTH, Texas, April 29, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), 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 data from the Company’s ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection is available on the Company’s website. These data were recently presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, via an oral presentation at the International Society for Heart and Lung Transplantation (ISHLT) 44th Annual Meeting during a late breaking clinical science abstract session on April 13, 2024. The data became available following the Company’s 8-K filing.

“Following the presentation of these updated data from our ongoing Phase 2 study of TFF TAC at this year’s ISHLT meeting, we have received highly positive feedback from the transplant medicine community, indicating heightened awareness of this innovative program and a growing enthusiasm for its potential to improve upon the current standard of care,” said Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “Looking ahead, we are focused on advancing this highly innovative program into potentially registrational testing, and we look forward to sharing additional data from the TFF TAC Phase 2 trial later this year.”

“These unprecedented results from our Phase 2 study provide evidence that TFF TAC has the potential to optimize lung immune suppression at decreased systemic exposures. TFF TAC can prevent rejection of the transplanted lung when delivered at only one-sixth of the oral tacrolimus dose and at two-thirds of the oral tacrolimus systemic trough exposures, levels predicted to decrease systemic toxicities,” said Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals. “In addition, our gene expression data demonstrate that TFF TAC normalizes the expression of genes associated with lung transplant rejection in patients whose systemic exposures are decreased, providing evidence at a molecular level that treatment with TFF TAC can increase lung immune suppression at reduced systemic exposures. These data collectively point to the potential opportunity to improve efficacy as well as safety after lung transplantation with TFF TAC.”

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 TAC (Tacrolimus Inhalation Powder) and TFF VORI (Voriconazole 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. 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 advancement of TFF TAC into potentially registration-enabling studies; the expectation that the initial data readouts for TFF TAC will be consistent with the further data from the ongoing Phase 2 clinical trial; and the benefits of the Company’s TFF platform. 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 further data from the ongoing Phase 2 clinical trial for TFF TAC will not be favorably consistent with the initial data initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for its TFF TAC candidate, (iii) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (iv) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (v) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF Platform, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trial, or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024. 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

FAQ

What Phase of the trial is TFF TAC in for the prevention of lung transplant rejection?

TFF TAC is in Phase 2 trial for the prevention of lung transplant rejection.

What is the dosage comparison of TFF TAC to oral tacrolimus for preventing lung transplant rejection?

TFF TAC can prevent rejection at one-sixth of the oral tacrolimus dose.

What do the gene expression biomarker data indicate about TFF TAC?

The gene expression data suggest that TFF TAC can normalize the expression of rejection-related genes.

When were the Phase 2 data presented at the ISHLT Annual Meeting?

The Phase 2 data were presented at the ISHLT Annual Meeting on April 13, 2024.

Where can the data from the Phase 2 trial of TFF TAC be found?

The data from the Phase 2 trial of TFF TAC can be found on the company's website.