FORT WORTH, Texas - TFF Pharmaceuticals, Inc. (NASDAQ:TFFP), a clinical-stage biopharmaceutical company, has announced a strategic shift in its clinical development priorities, focusing on the advancement of its Tacrolimus Inhalation Powder (TFF TAC) based on promising Phase 2 study results. The company's decision is driven by the potential of TFF TAC to address the unmet needs in lung transplant medicine and its significant market opportunity.
The Phase 2 data for TFF TAC indicated a favorable safety profile and efficacy in preventing acute rejection in lung transplant recipients. This has led to the company's decision to accelerate the clinical development pathway of TFF TAC towards registration. Dr. Zamaneh Mikhak, Chief Medical Officer at TFF Pharmaceuticals, highlighted the potential of TFF TAC to revolutionize the delivery of immunosuppressive therapy, overcoming the limitations of existing oral and IV tacrolimus formulations.
In contrast, the company is exploring strategic options for TFF VORI, including partnerships, collaborations, and grants, despite its positive data from the Phase 2 study and Expanded Access Program (EAP). TFF VORI, intended for the treatment of invasive pulmonary aspergillosis (IPA), has shown positive efficacy and safety outcomes, but the company has chosen to allocate resources preferentially to TFF TAC.
The clinical data updates for both TFF TAC and TFF VORI will be discussed in detail during a conference call on Wednesday, March 27, 2024, at 4:30 pm ET. The Phase 2 study for TFF TAC has shown that eight out of eight patients successfully transitioned from oral tacrolimus to TFF TAC, with no evidence of acute rejection. Additionally, TFF VORI has demonstrated positive efficacy in five out of six patients who completed treatment in the Phase 2 trial and EAP.
TFF Pharmaceuticals' proprietary Thin Film Freezing (TFF) technology platform is the foundation of its product candidates, including TFF TAC and TFF VORI. The TFF technology enables the transformation of drugs into dry powder formulations, potentially improving efficacy, safety, and stability.
This news is based on a press release statement from TFF Pharmaceuticals, Inc.
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