iloprost liposomal (L608) / Pharmosa Biopharm - LARVOL DELTA

Pharmosa Biopharm's long-acting inhaled drug candidate L608 has received U.S. FDA approval to proceed with a Phase 2 clinical trial targeting systemic sclerosis digital ulcers (SSc-DU) (BigGo) - "The trial plans to enroll 40 patients with a 28-day treatment period, with initiation expected by the end of this year and enrollment completion targeted for early 2028. The study will use an inhalation delivery device developed by Pharmosa's subsidiary Puren Pharmaceutical, marking the company's first entry into U.S. clinical development with a drug-device combination product featuring both its own drug and its own device."

IND • New P2 trial • Systemic Sclerosis

Human Pharmacokinetics of Inhaled Liposomal Iloprost Support a Dosing Regimen for Treating Systemic Sclerosis- Related Digital Ulcer (ACR Convergence 2025) - P1 | "Inhaled liposomal iloprost is an extended-release formulation [2] which prolongs iloprost exposure in healthy subjects as demonstrated in phase 1 clinical trial. The results support a 28-day dosing regimen for self-administration in treating patients with systemic sclerosis-related digital ulcer."

PK/PD data • Immunology • Scleroderma • Systemic Sclerosis

Tolerability and pharmacokinetics of inhaled liposomal iloprost in healthy adults show its potential of treating CTEPH (ERS 2025) - P1 | "Inhaled liposomal iloprost was tolerated by healthy adults, indicating its potential of treating CTEPH with convenient administration."

Clinical • PK/PD data • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Human Pharmacokinetics of Inhaled Liposomal Iloprost Indicates the Potential of Treating Systemic Sclerosis-Related Raynaud's Phenomenon and Digital Ulcer (EULAR 2025) - P1 | "Inhaled liposomal iloprost demonstrates extended-release formulation, supporting its potential for self-administration at home as a systemic therapy alternative to IV iloprost. These findings on human pharmacokinetics and tolerability highlight its promise in treating systemic sclerosis-related Raynaud’s phenomenon and digital ulcer."

PK/PD data • Cardiovascular • Immunology • Rheumatology • Scleroderma • Systemic Sclerosis

Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Pharmosa Biopharm Inc. | Recruiting ➔ Completed | Trial primary completion date: May 2024 ➔ Sep 2024

Trial completion • Trial primary completion date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

EXTENDED RELEASE OF INHALED ILOPROST LIPOSOME (L608) FOR TREATMENT OF SYSTEMIC SCLEROSIS-RELATED RAYNAUD PHENOMENA AND DIGITAL ULCER (EULAR 2024) - " The liposomal iloprost solution (L608) was prepared and characterized in terms of assay and encapsulation efficiency. Based on the rat PK data of sustained-release L608, the convenient dosage regimen with two to three inhalations per day is simulated to achieve the required plasma level for 6 hours a day, implying the potential to patient care."

Immunology • Scleroderma • Systemic Sclerosis

Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Pharmosa Biopharm Inc. | Not yet recruiting ➔ Recruiting

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