TFF Pharmaceuticals Announces Acceptance of Late-Breaking Abstract for Presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting
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Insights
The acceptance of TFF Pharmaceuticals' abstract for presentation at the ISHLT 2024 meeting is a pivotal moment for the company's Phase 2 study of Tacrolimus Inhalation Powder (TFF TAC). The potential of TFF TAC to revolutionize immunosuppressive therapy in lung transplant patients is significant, given the current 5-year mortality rate of approximately 50%. The direct delivery of tacrolimus to the lungs could mitigate the systemic toxicities that are often associated with oral or intravenous immunosuppressive drugs.
From a research perspective, the data presented will be critical in determining the efficacy and safety profile of TFF TAC. If positive, this could lead to expedited development and a potential increase in TFF Pharmaceuticals' market value. However, it is important to note that the biopharmaceutical sector is highly volatile and success in early clinical trials does not always translate to ultimate market success.
The announcement of TFF Pharmaceuticals' participation in the ISHLT 2024 meeting could influence investor sentiment, as clinical milestones like these are closely watched in the pharmaceutical industry. The presentation of positive initial Phase 2 data could result in increased investor confidence, potentially affecting the company's stock price. Investors should monitor the outcomes of this meeting, as it may have implications for the company's financial health and future funding requirements.
It is also essential to consider the competitive landscape and reimbursement challenges that TFF Pharmaceuticals may face if TFF TAC progresses to market. The cost-effectiveness and insurance coverage of new therapies are increasingly important factors in their commercial success.
As a pulmonologist, the development of TFF TAC is particularly interesting due to the high unmet need in lung transplant immunosuppression. Current systemic therapies can cause significant side effects, including nephrotoxicity and increased risk of infection. A localized delivery system like TFF TAC could potentially reduce these risks, improving patient outcomes. The upcoming presentation at the ISHLT meeting will be an important indicator of whether TFF TAC can deliver on its promise of targeted immunosuppression with fewer systemic side effects.
Furthermore, the novel Thin Film Freezing (TFF) technology platform used to develop TFF TAC could have broader implications for pulmonary drug delivery and the treatment of other lung conditions, should it prove successful in this application.
Presentation will feature initial data from the Company’s ongoing Phase 2 study of Tacrolimus Inhalation Powder (TFF TAC), which is being developed to prevent lung transplant rejection
FORT WORTH, Texas, Jan. 09, 2024 (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 the acceptance of a late-breaking abstract for presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting, which will be held in Prague, Czech Republic from April 10-13, 2024.
“Despite the availability of numerous immunosuppressive therapies, the unmet medical need remains high in lung transplantation, which has a 5-year mortality of approximately
About TFF TAC
The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity. Part A of the trial is a 12-week treatment period, and Part B is an optional safety extension period. Trial endpoints include safety/tolerability, kidney function, and acute allograft rejection.
ABOUT TFF PHARMACEUTICALS’ THIN FILM FREEZING (TFF) TECHNOLOGY
TFF Pharmaceuticals’ proprietary TFF technology allows for the transformation of 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 inhalational, 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 suggest the aerodynamic properties of the powders created by TFF can deliver as much as
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. 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 VORI and TFF TAC into potentially registration-enabling studies; the expectation that the initial data readouts for TFF VORI and TFF TAC will be consistent with the further data from the ongoing Phase 2 clinical trials and related EAP; 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 trials and related EAP for TFF VORI and 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 TFF VORI and TFF TAC candidates, (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 trials and related EAP, or advance to the initiation of registration-enabling studies, for TFF VORI and TFF TAC as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Quarterly Report on Form 10-Q filed with the SEC on November 14, 2023. 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
Source: TFF Pharmaceuticals, Inc.
FAQ
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