inhaled vardenafil (RT234) / Respira Therap - LARVOL DELTA

A Single Dose of RT234, Vardenafil Inhaled via the Axial Oscillating Sphere Dry Powder Inhaler (AOS™ DPI), Acutely Improves Exercise Capacity and Reduces Dyspnea in Pulmonary Arterial Hypertension (PAH) Patients (WHO Group 1 PH) - Results From the Open-label Phase 2b CPET (Cardiopulmonary Exercise Testing) Study (NCT04266197) (ATS 2025) - P2 | "A single dose of RT234 acutely increased exercise capacity in a dose-dependent manner and reduced exercise-induced dyspnea. For most responders, the observed increase in peak VO2 was clinically meaningful. RT234 is a novel approach to PAH treatment focused on improving activities with less dyspnea (i.e."

Clinical • Late-breaking abstract • P2b data • Cardiovascular • Fatigue • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Respira Therapeutics Announces Late-breaking Presentation of RT234 Phase 2b PAH Clinical Trial Results at the American Thoracic Society (ATS) 2025 International Conference (The Manila Times) - "Respira Therapeutics, Inc...announced that the Company will present results from its recently-completed RT234 Phase 2b CPET trial in PAH patients in a late-breaking session at the American Thoracic Society (ATS) 2025 International Conference, taking place from May 16th through 21st, in San Francisco, California."

P2b data • Pulmonary Arterial Hypertension

VIPAH-PRN 2B: Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: Respira Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | N=60 ➔ 42

Enrollment change • Enrollment closed • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

VIPAH-PRN 2B: Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Respira Therapeutics, Inc. | Phase classification: P2b ➔ P2 | N=86 ➔ 60 | Trial completion date: Apr 2024 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Nov 2024

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Safety and efficacy of RT234 vardenafil inhalation powder on exercise parameters in pulmonary arterial hypertension: phase II, dose-escalation study design. (PubMed, Respir Res) - P2b | "This is the first trial involving an as-needed medication for PAH. The trial will provide insights into the safety and efficacy of as-needed RT234 in treating the acute symptoms of PAH during exercise and will inform the design of further trials."

Journal • P2 data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234 (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Respira Therapeutics, Inc. | N=23 ➔ 31

Enrollment change

VIPAH-PRN 2B: Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study (clinicaltrials.gov) - P2b | N=83 | Recruiting | Sponsor: Respira Therapeutics, Inc. | N=40 ➔ 83

Enrollment change • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Dose Escalation Study to Evaluate the Effect of RT234 in Subjects With Pulmonary Arterial Hypertension (clinicaltrials.gov) - P2a | N=14 | Completed | Sponsor: Respira Therapeutics, Inc.

New P2a trial • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase 2B Study (clinicaltrials.gov) - P2b | N=40 | Recruiting | Sponsor: Respira Therapeutics, Inc. | Phase classification: P2 ➔ P2b | Trial completion date: Jul 2022 ➔ Feb 2024 | Trial primary completion date: May 2022 ➔ Dec 2023

Phase classification • Trial completion date • Trial primary completion date • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Effects of RT234 on Exercise Parameters Accessed by CPET in Subjects With PAH (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Respira Therapeutics, Inc.; N=20 ➔ 40; Trial completion date: Jun 2021 ➔ Jul 2022; Trial primary completion date: Mar 2021 ➔ May 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Safety, Tolerability, and Pharmacokinetics of RT234 (Vardenafil Inhalation Powder): A First-in-Human, Ascending Single- and Multiple-Dose Study in Healthy Subjects. (PubMed, J Aerosol Med Pulm Drug Deliv) - "These findings support further evaluation of RT234 for as-needed treatment of patients with PAH. The Clinical Trials Registration number is ACTRN12618001077257."

Clinical • Journal • P1 data • PK/PD data • Hypertension • Immunology • Inflammation • Pain • Pulmonary Arterial Hypertension • Respiratory Diseases

[VIRTUAL] Acute Hemodynamic Improvement in Chronic Pulmonary Arterial Hypertension on Dual Therapy Following RT234 Inhalation (CHEST 2020) - No abstract available

Hypertension • Pulmonary Arterial Hypertension

[VIRTUAL] SAFETY AND PHARMACOKINETICS OF VARDENAFIL INHALATION POWDER (RT234) FOLLOWING ORAL INHALATION IN HEALTHY ADULT VOLUNTEERS (CHEST 2020) - "Vardenafil Inhalation Powder (RT234), was found to be safe and well tolerated when orally inhaled in normal human volunteers. This study indicates that vardenafil, administered via oral inhalation, is rapidly absorbed into the bloodstream, and when combined with vardenafil’s known long binding time at the catalytic receptor on the phosphodiesterase-5 enzyme, is well-suited for further clinical development as an as-needed therapeutic in PAH. CLINICAL IMPLICATIONS: Safety and Pharmacokinetics of Vardenafil Inhalation Powder (RT234) are ideal for further development as an as-needed therapy for PAH."

Clinical • PK/PD data • Cardiovascular • Hypertension • Pain • Pulmonary Arterial Hypertension

Effects of RT234 on Exercise Parameters Accessed by CPET in Subjects With PAH (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Respira Therapeutics, Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hypertension • Pulmonary Arterial Hypertension

[VIRTUAL] Inspiratory flow profiles of PAH patients with AOS™ device intended to administer inhaled vardenafil (ERS 2020) - "Thirty-five PAH pts (mean age 49.7±12.2 y, 91.4% female, 91.4% FC II-III) were enrolled. The mean peak inspiratory pressure (PIP) was 6.2±2.4 kPa. The mean inhaled volume (Vi) was 1.62±0.47 L. All of the PAH patients in the present study exceeded the PIP > 1 kPa and Vi > 0.5 L requirements for effective pulmonary delivery of vardenafil with the portable AOS DPI (Figure)."

Clinical

Effects of RT234 on Exercise Parameters Accessed by CPET in Subjects With PAH (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Respira Therapeutics, Inc.; Trial completion date: Jan 2021 ➔ Jun 2021; Initiation date: Mar 2020 ➔ Sep 2020; Trial primary completion date: Sep 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial initiation date • Trial primary completion date

Safety and Pharmacokinetics of Vardenafil Inhalation Powder (RT234) Following Oral Inhalation in Healthy Adult Volunteers (ATS 2020) - "Abstract embargoed at this time."

Clinical • PK/PD data

Effects of RT234 on Exercise Parameters Accessed by CPET in Subjects With PAH (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Respira Therapeutics, Inc.

Clinical • New P2 trial