voriconazole inhalation powder (TFF VORI) / TFF Pharma - LARVOL DELTA

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

Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis (clinicaltrials.gov) - P=N/A | N=N/A | Available | Sponsor: TFF Pharmaceuticals, Inc.

New trial • Allergic Bronchopulmonary Aspergillosis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

A Phase 2 Study of Voriconazole Inhalation Powder Compared to Oral Voriconazole Tablets in Subjects with Acute Invasive Pulmonary Aspergillosis (IPA) (clinicaltrialsregister.eu) - P2 | N=40 | Ongoing | Sponsor: TFF Pharmaceuticals, Inc.

New P2 trial • Pulmonary Disease • Respiratory Diseases

TFF Pharmaceuticals Announces Final Data from Phase 1b Study of Inhaled Voriconazole Powder in Asthma Patients (GlobeNewswire) - P1b, N=17; NCT04576325; Sponsor: TFF Pharmaceuticals; "TFF Pharmaceuticals...today announced the full readout of safety and pharmacokinetic (PK) data from its Phase 1b study (NCT #04576325) of Inhaled Voriconazole Powder (TFF VORI) in asthma patients....The data reported from the Phase 1b study are consistent with the initial data reported in November suggesting that TFF VORI is well tolerated in asthma patients and could therefore provide a differentiating benefit to a broad population of patients with IPA....'with this latest data readout we are now poised to advance one of our key internal product candidates into late-stage clinical testing in 2022.'"

P1 data • Asthma • Infectious Disease • Respiratory Diseases

Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma (clinicaltrials.gov) - P1; N=17; Completed; Sponsor: TFF Pharmaceuticals, Inc.; Recruiting ➔ Completed; N=30 ➔ 17

Clinical • Enrollment change • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TFF Pharmaceuticals Announces Completion of Dosing of Phase 1b Study for Voriconazole Inhalation Powder in Mild to Moderate Asthma Patients (GlobeNewswire) - P1b, N=30; NCT04576325; Sponsor: TFF Pharmaceuticals, Inc.; "TFF Pharmaceuticals...today announced the completion of dosing in the Phase 1b clinical trial of Voriconazole Inhalation Powder (TFF VORI)...inhaled dry powder version of voriconazole for the treatment and prevention of Invasive Pulmonary Aspergillosis (IPA)...Initial data from the study suggests that TFF VORI is well tolerated in asthma patients, supporting the Company’s progress to Phase 2 study in IPA patients....There were two cohorts in this study. In cohort 1, 8 eligible subjects were randomized in a 3:1 ratio (6 on active and 2 on placebo) to receive 7 doses BID over 3.5 days of 40mg VIP or inhaled placebo. In cohort 2, 8 eligible subjects were also randomized in a 3:1 ratio to receive 7 doses BID over 3.5 days of 80 mg VIP or placebo. In both cohorts, doses were administered twice daily every 12 (± 1) hours."

P1 data • Trial status • Asthma • Respiratory Diseases

Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: TFF Pharmaceuticals, Inc.; Trial primary completion date: Jul 2021 ➔ Nov 2021

Clinical • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

TFF Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update (Businesswire) - "TFF has...successfully completed the first of two dosing cohorts in asthma patients to evaluate safe dosing in patients with hyperreactive airways. There have been no serious adverse events reported in these cohorts. The Company is currently in active preparations for an end of Phase 1 meeting with the FDA, and we anticipate this meeting will be held after the dosing in this Phase 1b asthma study is complete. We then expect to initiate a pivotal clinical trial designed to demonstrate efficacy for treating patients with IPA or for preventing infection in patients at high risk for developing IPA infections."

Trial status • Asthma • Respiratory Diseases

Single Ascending Dose and Multiple Ascending Dose Study of Voriconazole Inhalation Powder in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=65; Completed; Sponsor: TFF Pharmaceuticals, Inc.

Clinical • New P1 trial

Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: TFF Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Respiratory Diseases

TFF Pharmaceuticals Provides Update on Clinical Development Programs (Businesswire) - "...TFF is continuing to enroll asthma patients in a Phase 1b study to understand if the Voriconazole Inhalation Powder is likely to trigger bronchospasm in patients with hyperreactive airway disease....TFF is completing this reactive airway study to guide the clinical practice in patients with hyperreactive airway diseases (Asthma and COPD). The data from this study and from the completed healthy normal Phase 1 study will lead to the initiation of a pivotal study of Voriconazole Inhalation Powder, which will begin enrolling patients later this year."

Enrollment status • New trial • Asthma • Respiratory Diseases

TFF Pharmaceuticals Announces First Dosing of Asthma Patients with Voriconazole Inhalation Powder in a Phase 1b Clinical Trial (Businesswire) - "TFF Pharmaceuticals...today announced dosing of the first subjects in its Phase 1b clinical trial of Voriconazole Inhalation Powder, a next-generation, direct-to-lung, inhaled dry powder version of voriconazole...TFF Pharmaceuticals is conducting this Phase 1b clinical trial of Voriconazole Inhalation Powder in patients with asthma to assess the safety, pharmacokinetics, and induction of bronchospasm."

Trial status • Asthma • Infectious Disease • Respiratory Diseases

Pharmacokinetic Profile of Voriconazole Inhalation Powder in Adult Subjects With Asthma (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: TFF Pharmaceuticals, Inc.

Clinical • New P1 trial • Asthma • Respiratory Diseases

TFF Pharmaceuticals Announces Completion of Dosing for Voriconazole Inhalation Powder Phase 1 Clinical Trial (Businesswire) - P1, N=32; "TFF Pharmaceuticals, Inc....today announced that the last subject in the multiple ascending dose (MAD) portion of its Phase 1 clinical trial of Voriconazole Inhalation Powder completed their last clinic visit, following repeated dosing....The Company reports that repeated doses of up to 80 mg/dose twice daily for 7-days in healthy normal volunteers was well tolerated....Previously, TFF released topline data from the single ascending dose portion of the study and showed that single doses of 80 mg were safe."

P1 data • Trial completion