Company to
Company to Evaluate Strategic Options for TFF VORI, including Partnerships, Collaborations, and Grants following Positive Data from Phase 2 Study and the Expanded Access Program (EAP)
Company to Discuss Clinical Updates on TFF TAC and TFF VORI on
“For decades, legacy immunosuppressive drugs such as IV and oral tacrolimus, while effective in preventing acute rejection, have resulted in an unacceptable level of systemic toxicities, which has created constant challenges in maintaining the overall health of the transplant recipient,” said Zamaneh Mikhak, M.D., Chief Medical Officer of
“With respect to TFF VORI, the positive safety and efficacy from the Phase 2 study and the EAP continue to suggest that this product represents a significant improvement over the oral and intravenous formulation of voriconazole,” said
TFF TAC and TFF VORI Clinical Data Updates
On
In summary, for TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study. There has been no evidence of acute rejection, and four out of four patients who completed the 12-week treatment period of the study chose to remain on TFF TAC and proceed to the long-term extension of the trial. TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
For TFF VORI, a total of nine patients have enrolled between the Phase 2 trial and the EAP. The Company continues to see positive efficacy results, with five of six patients who have completed treatment achieving a clinical and mycologic response. TFF VORI continues to maintain an attractive safety profile with no all-cause mortality or IPA-related mortality.
Conference Call and Webcast Information
The Company will host a conference call on
Domestic Dial-In Number: Toll-Free: 1-888-886-7786
International Dial-In Number: 1-416-764-8658
Conference ID: 24531709
Call me™: LINK (will be made active 15 minutes prior to the scheduled start time)
The call will also be broadcast live over the Web and can be accessed on TFF Pharmaceuticals’ Website, https://tffpharma.com or directly at https://viavid.webcasts.com/starthere.jsp?ei=1658279&tp_key=8445c4138a
The conference call will also be available for replay for one month on the Company's website in the Events Calendar of the Investors section.
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
SAFE HARBOR
This press release contains forward-looking statements regarding TFF Pharmaceuticals, Inc., including the advancement of TFF TAC into potentially registration-enabling studies; TFF TAC’s substantial market opportunity; the expectation that the further data from the ongoing Phase 2 clinical trial for TFF TAC will be consistent with the data readouts for TFF TAC to date; and our exploration of strategic alternatives for TFF VORI, including partnering opportunities, collaborations, and government-based funding sources; 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 for TFF TAC will not be favorably consistent with the initial data readouts, (ii) the risk that the Company may not be able to advance to registration-enabling studies for TFF TAC, (iii) the risk we may not be successful in our pursuit of strategic alternatives for TFF VORI; (iv) success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) no drug product incorporating the TFF platform has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the Company has no current agreements or understandings with any large pharmaceutical companies for the development of a drug product incorporating the TFF platform, (vii) the risk that the Company may not be able to obtain additional working capital with which to continue the Phase 2 clinical trials and or advance to the initiation of registration-enabling studies, for TFF TAC as and when needed and (viii) 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:
(212) 915-2577
cdavis@lifesciadvisors.com
Source:
2024 GlobeNewswire, Inc., source