TFF Pharmaceuticals Provides Regulatory Update on Tacrolimus Inhalation Powder (TFF TAC) Clinical Program for the Prevention of Lung Transplant Rejection
TFF Pharmaceuticals has announced a regulatory update for its Tacrolimus Inhalation Powder (TFF TAC) clinical program. Following a recent interaction, the FDA provided constructive feedback and guidance on the clinical development pathway.
The FDA agreed that mitigating or preventing tacrolimus-associated toxicities without risking lung allograft is a significant therapeutic benefit. TFF Pharmaceuticals does not anticipate any major changes to timelines or costs for TFF TAC's clinical advancement.
Dr. Zamaneh Mikhak, Chief Medical Officer, noted that additional guidance from the FDA is expected in the upcoming weeks, with a more detailed regulatory update to be provided in the third quarter of 2024.
- FDA provided constructive feedback and guidance on TFF TAC's clinical development.
- FDA acknowledged the significant therapeutic benefit of TFF TAC in mitigating or preventing tacrolimus-associated toxicities without risking lung allograft.
- No major changes expected in timelines or estimated costs for the clinical advancement of TFF TAC.
- Additional FDA guidance required, delaying a detailed regulatory update until Q3 2024.
Insights
The FDA's feedback on TFF Pharmaceuticals' Tacrolimus Inhalation Powder (TFF TAC) is a significant development in the clinical pathway for this potential treatment for lung transplant rejection. This feedback suggests that the FDA sees potential in the product's ability to mitigate or prevent tacrolimus-associated toxicities, which is a major concern for lung transplant patients. It's important to note that tacrolimus is an immunosuppressant that can cause serious side effects, so a less toxic formulation could be highly valuable.
For retail investors, the absence of significant changes to the timelines or costs is reassuring, indicating that the program is on track and there are no unexpected financial burdens emerging from this phase of the development process. In the long term, if TFF TAC proves effective with fewer side effects, it could capture a considerable market share in the transplant immunosuppressant arena. However, it is critical to remain aware of the inherent risks in clinical development, including potential setbacks in upcoming trials.
From a financial perspective, the FDA's constructive feedback and the company's reassurance about timelines and costs are positives. Investors often worry about unexpected delays and cost overruns in clinical trials, so maintaining the projected schedule without additional financial burdens is encouraging. This could help maintain or potentially boost investor confidence in TFF Pharmaceuticals' management and execution capabilities.
Short-term, this news might not dramatically move the stock price, but it does add a layer of certainty which is always welcomed by the market. Long-term, successful advancement through clinical trials can lead to substantial upside, given the potential market for a safer tacrolimus alternative. However, investors should be cautious of the typical risks associated with clinical-stage biotech companies, including the high failure rate of trials and the need for additional funding as the company progresses.
FDA Provided Constructive Feedback to Help Guide Next Steps in TFF TAC Clinical Development
Company to Provide More Detailed Regulatory Update in 3Q 2024
FORT WORTH, Texas, June 24, 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 a regulatory update on the Company’s TFF TAC clinical program following its recent interaction with the U.S. Food and Drug Administration (FDA).
In April 2024, the Company submitted a briefing book to the FDA to help guide the next steps in the clinical development pathway for TFF TAC. Following its review of the briefing book, the FDA concurred that mitigation or prevention of tacrolimus associated toxicities without placing the lung allograft at risk will be an important therapeutic benefit and provided constructive feedback and valuable guidance on the roadmap for advancement of TFF TAC. Based on this feedback, the Company does not expect a significant change to either its timelines or the estimated costs associated with the clinical advancement of TFF TAC.
“The initial feedback from the FDA on the TFF TAC clinical program has provided us with additional clarity on how we can continue advancing this innovative product towards registrational testing,” said Dr. Zamaneh Mikhak, Chief Medical Officer of TFF Pharmaceuticals. “Over the next several weeks, we expect to receive additional guidance from the FDA, which should allow us to provide a more detailed regulatory update on the program in the third quarter of 2024.”
About TFF TAC
TFF TAC is an inhaled dry powder formulation of tacrolimus, a potent immunosuppressive drug. Oral tacrolimus is currently the first line calcineurin inhibitor used for prevention of rejection after solid organ transplantation but it is associated with many toxicities such as kidney toxicity, particularly when high doses are needed as is the case after lung transplantation.
TFF TAC delivers tacrolimus directly to the lung to yield improved lung immunosuppression at lower doses and systemic exposures compared to oral tacrolimus to improve efficacy and decrease systemic toxicities such as kidney toxicity. TFF TAC is delivered via an easy-to-use dry powder inhaler.
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 and tolerability including kidney function, acute allograft rejection and pharmacokinetics.
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
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 skin.
SAFE HARBOR
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the expectation that the further guidance from the FDA concerning TFF TAC will be consistent with the FDA guidance received to date, the Company’s ability to progress TFF TAC towards registrational testing 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 guidance from the FDA concerning TFF TAC will not be favorably consistent with the guidance received to date, (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 Quarterly Report on Form 10-Q filed with the SEC on May 14, 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, (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 May 14, 2024. The Company cautions readers not to place undue reliance on any forward-looking statements. The Company 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
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