PHIN-214 / PharmaIN - LARVOL DELTA

PHASE 1, SINGLE-ASCENDING DOSE RESULTS: FROM THE PHIN-001 STUDY OF PHIN-214 IN COMPENSATED AND DECOMPENSATED PATIENTS WITH CIRRHOSIS (AASLD 2025) - P1 | "A single subcutaneous dose of PHIN-214 was safe, well tolerated and showed a physiologic profile consistent with V1a activation. Early signs of clinical activity as evidenced by improvement in eGFR and a strong correlation with PHIN-156 exposure support continued development of PHIN-214 as a once-daily, self-administered treatment for portal hypertension in cirrhosis. Complete single-dose and emerging multi-dose data will be presented."

Clinical • P1 data • Cardiovascular • Fibrosis • Hepatology • Hypertension • Immunology • Portal Hypertension

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics (clinicaltrials.gov) - P1 | N=74 | Recruiting | Sponsor: PharmaIN | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Oct 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

PHIN-214: PHASE 1 STUDY IN COMPENSATED AND DECOMPENSATED PATIENTS WITH CIRRHOSIS - A NOVEL TREATMENT TO MANAGE COMPLICATIONS OF PORTAL HYPERTENSION WITH SUBCUTANEOUS, ONCE-DAILY SELF-ADMINISTRATION (AASLD 2024) - "Single, subcutaneous injection of PHIN-214 was safe, well tolerated, and yielded preliminary evidence of clinical activity at all dose levels administered. These data support further development of PHIN-214 as a self-administered, subcutaneous, once-daily injection for treatment of complications of portal hypertension in patients with decompensated cirrhosis. Updated data will be included in the final presentation."

Clinical • P1 data • Cardiovascular • Fibrosis • Heart Failure • Hepatology • Immunology • Infectious Disease • Nephrology • Portal Hypertension

Preclinical and clinical evaluation of PHIN-214, a vasoactive peptide (EASL-ILC 2024) - No abstract available

Preclinical • Fibrosis • Hepatology • Hypertension • Immunology • Portal Hypertension

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: PharmaIN | Trial completion date: Feb 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Oct 2025

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

Subcutaneous therapy for portal hypertension: PHIN-214, a partial vasopressin receptor 1A agonist. (PubMed, Biomed Pharmacother) - "In bile duct ligated rats with PH, subcutaneous PHIN-214 reduced portal pressure by 13.4 % ± 3.4 in 4 h. These collective findings suggest that PHIN-214 could be a novel pharmacological treatment for patients with PH, potentially administered outside of hospital settings, providing a safe and convenient alternative for managing PH and its complications."

Journal • Cardiovascular • Fibrosis • Heart Failure • Hepatology • Hypertension • Immunology • Liver Cirrhosis • Nephrology • Portal Hypertension • Renal Disease

Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics (clinicaltrials.gov) - P1 | N=37 | Recruiting | Sponsor: PharmaIN | N=13 ➔ 37

Enrollment change • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

Single Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: PharmaIN | Trial completion date: Feb 2023 ➔ Feb 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Immunology • Liver Cirrhosis

Single Dose Escalation of PHIN-214 in Child-Pugh A Liver Cirrhotics (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: PharmaIN

New P1 trial • Fibrosis • Hepatology • Immunology • Liver Cirrhosis