tacrolimus inhalation powder (TFF TAC-LAC) / TFF Pharma - LARVOL DELTA

Multicenter Open-Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics (PK) of Tacrolimus Inhalational Powder as a Replacement to Oral Tacrolimus (TAC) in Lung Transplant (LTx) Recipients with Renal Insufficiency (ISHLT 2025) - "Number of abnormally expressed MMDx rejection-related gene sets have decreased 6.5-fold (85%) on TIP (1.625 on oral TAC vs. 0.25 on TIP; 0 in 66% of patients with abnormal expression at baseline).Conclusion TIP shows promise as a novel LTx immunosuppressant with potential to prevent allograft rejection while decreasing systemic TAC toxicity. Further details and analyses will be available for ISHLT presentation."

Clinical • PK/PD data • Infectious Disease • Nephrology • Oncology • Renal Cell Carcinoma • Renal Disease • Transplant Rejection • Transplantation

TFF-T2-001: An Open Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetic Profile of Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients (clinicaltrials.gov) - P2 | N=14 | Terminated | Sponsor: TFF Pharmaceuticals, Inc. | N=24 ➔ 14 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2025 ➔ Oct 2024; Study was terminated due to funding constraints

Enrollment change • Trial primary completion date • Trial termination • Immunology • Transplant Rejection • Transplantation

TFF Pharmaceuticals Provides Continued Positive Outcomes from Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the Prevention of Lung Transplant Rejection (GlobeNewswire) - P2 | N=24 | NCT05501574 | Sponsor: TFF Pharmaceuticals, Inc. | "TFF Pharmaceuticals...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....Patient enrollment has accelerated with 13 patients now enrolled in Phase 2 trial. TFF TAC at ~20% of the oral tacrolimus dose prevented acute rejection and achieved >80% of the oral trough blood levels leading to diminished drug burden...9 out of 9 (100%) patients who completed the 12-week treatment period with TFF TAC chose to remain on the therapy by proceeding to the long-term extension phase...Updated biomarker data indicate a 6.5-fold reduction in the number of abnormally expressed rejection-related gene sets after 12 weeks of treatment with TFF TAC....New biomarker data exploring the presence of donor-specific antibodies (DSA) are now available in the first 8 patients from the study."

Biomarker • P2 data • Transplant Rejection

TFF Pharmaceuticals Provides Regulatory Update on Tacrolimus Inhalation Powder (TFF TAC) Clinical Program for the Prevention of Lung Transplant Rejection (GlobeNewswire) - "TFF Pharmaceuticals...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)....'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,'.....'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.'"

FDA event • Transplant Rejection

TFF Pharmaceuticals Announces Additional Positive Data from the Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial Following Oral Presentation at the ISHLT 44th Annual Late Breaking Clinical Science Abstract Sessions (Yahoo Finance) - P2 | N=24 | NCT05501574 | Sponsor: TFF Pharmaceuticals, Inc. | "TFF Pharmaceuticals...today announced additional positive data from the ongoing Phase 2 study which is evaluating Tacrolimus Inhalation Powder (TFF TAC) for the prevention of organ rejection in lung transplant recipients....Updated Efficacy: Successful transition of eight of eight patients from oral Tacrolimus to TFF TAC. 4/4 patients who completed Part A chose to remain on TFF TAC and proceeded to Part B....Updated Safety: No mortality. No TFF TAC discontinuation due to an AE....Based on these highly encouraging results, TFF Pharmaceuticals plans to open an IND in the US to explore the use of TFF TAC early post-transplant in preparation for a registrational trial."

P2 data • Transplant Rejection

TFF Pharmaceuticals Provides Update on Tacrolimus Inhalation Powder (TFF TAC) Phase 2 Trial for the Prevention of Lung Transplant Rejection (GlobeNewswire) - P2 | N=24 | NCT05501574 | Sponsor: TFF Pharmaceuticals, Inc. | "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.'...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....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...'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.'"

P2 data • Transplant Rejection

TFF Pharmaceuticals Makes Available Phase 2 Data from Tacrolimus Inhalation Powder (TFF TAC) for the Prevention of Lung Transplant Rejection Presented at the Recent ISHLT Annual Meeting (GlobeNewswire) - "TFF Pharmaceuticals...today announced that data from the Company’s ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant rejection is available on the Company’s website. These data were recently presented by Professor Gregory Snell, the lead Principal Investigator of the TFF TAC Phase 2 study, via an oral presentation at the International Society for Heart and Lung Transplantation (ISHLT) 44th Annual Meeting during a late breaking clinical science abstract session on April 13, 2024...and we look forward to sharing additional data from the TFF TAC Phase 2 trial later this year.'"

P2 data • Transplant Rejection

Multicenter Open-Label Tacrolimus Inhalation Powder Trial Evaluating Safety, Tolerability, Efficacy and Pharmacokinetics (pk) in Lung Transplant (ltx) Recipients with Significant Renal Impairment (ISHLT 2024) - "Emerging experience and BAL levels will prove key in potentially in enabling us to lower blood TAC levels even further. Significant numbers and further safety, efficacy endpoints and analyses will be available for presentation at ISHLT."

Clinical • Late-breaking abstract • PK/PD data • Renal Disease • Transplant Rejection • Transplantation

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs (GlobeNewswire) - P2 | N=24 | NCT05501574 | Sponsor: TFF Pharmaceuticals, Inc. | "TFF Pharmaceuticals...today announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs...'Today’s updated data provide further promising evidence in support of the continued development of both TFF TAC and TFF VORI, with the interim clinical data suggesting that each product can be delivered safely and efficaciously into the lungs,'....the Company is presenting new data from the ongoing Phase 2 study of TFF TAC for the prevention of acute rejection in lung transplant, and from the Phase 2 study and the Expanded Access Program (EAP) of TFF VORI for the treatment of invasive pulmonary aspergillosis (IPA)....'Biomarker data will be disclosed at a Late Breaking Clinical Science abstract session at 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting on April 13, 2024. Professor Gregory..."

P2 data • Transplant Rejection

TFF Pharmaceuticals Announces Oral Presentation of Interim Data from the Phase 2 Study of Tacrolimus Inhalation Powder (TFF TAC) for the Prevention of Lung Transplant Rejection at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting (GlobeNewswire) - "TFF Pharmaceuticals...today announced the acceptance of its late-breaking clinical science abstract for oral 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....'Results from the ongoing Phase 2 trial of TFF TAC continue to suggest that targeted, inhalational delivery of tacrolimus has the potential to provide sufficient immunosuppression to avoid acute rejection at diminished systemic exposures compared to oral tacrolimus...and I look forward to presenting updated data from the Phase 2 trial at the upcoming ISHLT 2024 meeting.'"

P2 data • Transplant Rejection

TFF Pharmaceuticals Announces Acceptance of Late-Breaking Abstract for Presentation at the 44th Annual International Society for Heart and Lung Transplantation (ISHLT) 2024 Meeting (GlobeNewswire) - "TFF Pharmaceuticals...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....'Initial data from the ongoing Phase 2 study suggest that TFF TAC, which delivers tacrolimus directly to the lungs, may represent a viable approach in achieving this desired balance, and I look forward to presenting initial data from the Phase 2 trial at the upcoming ISHLT 2024 meeting.'"

P2 data • Transplant Rejection

An Open Label Trial Evaluating Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: TFF Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Transplant Rejection • Transplantation

An Open Label Trial Evaluating Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: TFF Pharmaceuticals, Inc.

New P2 trial • Immunology • Transplant Rejection • Transplantation

TFF Pharmaceuticals Updates Progress of Human Clinical Trial with Tacrolimus Inhalation Powder (BioSpace) - "Company completes dosing of three cohorts with Tacrolimus Inhalation Powder for direct-to-lung delivery of a Thin Film Freezing dry-powder product for prevention of lung transplant rejection...Single ascending dose cohorts to date shown to be safe with no clinically significant drug-associated adverse events, while achieving substantial immunosuppressive blood levels... The final safety data from all five cohorts in the SAD portion of the study will be used to commence the MAD portion of the trial, with dosing of the first cohort in the MAD phase to be initiated soon."

Trial status • Graft versus Host Disease • Immunology

TFF Pharmaceuticals Updates Progress of Human Clinical Trial with Tacrolimus Inhalation Powder (BioSpace) - "TFF Pharmaceuticals...today announced that it has successfully completed the single ascending dosing of three cohorts of healthy subjects for its second clinical program, Tacrolimus Inhalation Powder for the prevention of lung transplant rejection....Single ascending dose cohorts to date shown to be safe with no clinically significant drug-associated adverse events, while achieving substantial immunosuppressive blood levels..."

Trial status • Graft versus Host Disease • Immunology