TFF Pharmaceuticals Provides Update on Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the Prevention of Lung Transplant Rejection
TFF Pharmaceuticals announced an update on its Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for preventing lung transplant rejection. The trial has accelerated patient enrollment with 10 patients currently enrolled. All 6 patients who completed the 12-week treatment have opted to continue to the safety extension phase. One patient has been on treatment for over a year, and three others for more than six months.
The initial pharmacokinetic (PK) data shows reduced systemic variability with TFF TAC, potentially lowering risks of acute rejection and systemic toxicities. Positive feedback includes reduced headaches and improved wellness. A more detailed clinical update is expected later in the year.
- Enrollment in the Phase 2 trial has accelerated, with 10 patients currently enrolled.
- All 6 patients who completed the 12-week treatment have chosen to continue to the safety extension phase.
- Positive feedback from patients includes reduced headaches and overall improvements in wellness.
- TFF TAC shows reduced systemic variability in tacrolimus levels, potentially lowering the risks of acute rejection and systemic toxicities.
- The TFF TAC inhalation device is user-friendly, which may improve patient compliance.
- The press release lacks detailed financial data, limiting the scope of investment analysis.
- No concrete clinical outcomes or efficacy metrics have been provided, making it difficult to assess the trial's success.
- The report does not disclose any adverse effects observed, which could be vital for investors.
Insights
The Phase 2 trial update for Tacrolimus Inhalation Powder (TFF TAC) by TFF Pharmaceuticals provides promising insights into the potential of this novel delivery method. The most notable point is the acceleration in patient enrollment, now at 10 patients. This uptick suggests heightened confidence from the medical community, likely driven by initial positive data and anecdotal patient feedback. The fact that 100% of patients who completed the 12-week treatment opted to continue in the safety extension phase is noteworthy. This implies not only patient satisfaction but also perceived benefits from the treatment.
Reduced systemic exposure variability, highlighted in the Pharmacokinetic (PK) data, is a significant development. Traditional oral tacrolimus administration is often marred by swings in drug concentration, leading to higher risks of acute rejection and systemic toxicities such as chronic kidney disease. By providing a more targeted lung delivery, TFF TAC could mitigate these issues, presenting a safer alternative for lung transplant recipients. The initial patient feedback, reporting fewer headaches and easier administration, further supports the potential of this inhalation therapy to enhance patient compliance and quality of life.
From an investor's perspective, these early positive signs indicate that TFF Pharmaceuticals is on the right track with its TFF TAC trial. The continued progress in this trial could catalyze significant advancements in the company's portfolio of inhalation therapies.
The latest update from TFF Pharmaceuticals on their TFF TAC Phase 2 trial suggests a strong outlook for the company. The increased patient enrollment and continued participation in the safety extension phase are positive indicators of the drug's acceptance and perceived efficacy. For stakeholders, these factors can be seen as a harbinger of potential future revenue streams.
One of the most compelling data points is the reduction in systemic tacrolimus variability. This improvement could position TFF TAC as a leading therapy for the prevention of lung transplant rejection, providing a competitive edge in the market. The mention of physician enthusiasm further underscores the medical community's support, which is important for gaining market traction post-approval.
Moreover, given the possible reduction in kidney toxicity and ease of use, TFF TAC might reduce the overall healthcare costs associated with lung transplants by decreasing the frequency of adverse events and improving patient compliance. These benefits could be substantial selling points when negotiating with healthcare providers and insurance companies.
Investors should consider the long-term potential of this innovation, keeping an eye on further trial results and regulatory milestones. The news reflects positively on TFFP's prospects, potentially driving the stock higher as confidence in the product grows.
Patient Enrollment Has Accelerated with Now 10 Patients Enrolled in Phase 2 Trial
6 out of 6 Patients Who Completed the 12-Week Treatment Have Chosen to Remain on TFF TAC by Proceeding to the Safety Extension Phase; 1 patient has been treated for over a year and 3 additional patients have been treated for more than 6 months
Variability in Systemic Exposure to Tacrolimus Was Reduced with TFF TAC Which Could Lower Risk of Acute Rejection and Systemic Toxicities
FORT WORTH, Texas, May 15, 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 provided an update from the Company’s ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection.
“I am pleased to report that patient enrollment has accelerated due to positive physician enthusiasm based on emerging data, and we have now enrolled 10 patients in the TFF TAC Phase 2 study,” said Dr. Harlan Weisman, Chief Executive Officer of TFF Pharmaceuticals. “As we continue to grow the body of clinical data for TFF TAC, we anticipate providing a more detailed clinical update on the Phase 2 trial later in the year.”
Program update
- The Phase 2 study now has 10 patients enrolled and 6 out of 6 patients who completed the 12-week treatment period with TFF TAC have chosen to remain on the therapy by proceeding to the safety extension phase. 1 patient has been treated for over a year and 3 additional patients have been treated for more than 6 months
- PK data from first patient cohort indicate that TFF TAC dosing results in reduced systemic variability of tacrolimus; the systemic tacrolimus trough to peak concentration swings that occur with oral tacrolimus are not present with TFF TAC, which is predicted to reduce the risk of acute rejection and systemic toxicities such as chronic kidney disease, respectively
- Patients on TFF TAC have provided anecdotal feedback to investigators noting a reduction in headaches, overall improvements in wellness, and/or ease of use in administration
“We are encouraged by the initial positive feedback we are receiving from patients who have been receiving TFF TAC over an extended period of time, which is not altogether surprising given TFF TAC’s more precise, targeted delivery into the lungs versus oral administration of tacrolimus,” said Dr. Zamaneh Mikhak, Chief Medical Officer. “Furthermore, initial PK data from the first patient cohort indicate that dosing with TFF TAC results in less variability in the levels of systemic tacrolimus. By reducing systemic tacrolimus trough and peak concentration swings through more targeted delivery, we believe TFF TAC has the potential to reduce the incidence of acute rejection and kidney toxicity, respectively. In addition, we have received positive feedback on the ease of use of the TFF TAC inhalation device, which is a small portable inhaler that requires no priming or spacer, making it easy for patients to inhale drug and likely leading to improved compliance.”
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 the 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 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 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.
Investor Relations Contact:
Corey Davis, Ph.D.
LifeSci Advisors
(212) 915-2577
cdavis@lifesciadvisors.com
FAQ
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