Amphisiran (SAMiRNA-AREG) / siRNAgen - LARVOL DELTA

The First-in-human Study of SRN-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: siRNAgen Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Bioneer, SRN-001 Phase 1a Clinical Trial "No Safety Issues" (Hankyung) - "Bioneer announced...that it has received the final clinical trial phase 1a result report (CSR) for its next-generation new drug candidate 'SRN-001' that it is developing....In this trial, it was confirmed that exposure increased in proportion to the dose when SRN-001 was administered intravenously, and no cytokine changes or anti-SRN-001 antibodies were observed related to immunogenicity, which is one of the biggest challenges related to the safety of siRNA therapeutics. In addition, it was confirmed that there were no significant changes before and after administration in all safety evaluation items, including electrocardiograms, proving that there were no safety issues even at the highest dose of this clinical trial when administered intravenously to humans once."

P1 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease

Sunagen Therapeutics, Positive Results of Phase 1a Clinical Trial of New Drug for Idiopathic Pulmonary Fibrosis (Google translation) (Newspim) - P1 | N=24 | NCT05984992 | Sponsor: siRNAgen Therapeutics Inc. | "Sunagen Therapeutics (hereinafter referred to as Sunagen), a subsidiary of Bioneer, announced on the 20th that it had confirmed positive results through a draft report of the phase 1a clinical trial of SRN-001, a first-in-class anti-fibrotic new drug based on RNAi....SRN-001 has confirmed sufficient safety and tolerability in humans. This clinical trial is the first case in which siRNA using the SAMiRNA platform was studied through systemic administration to humans, and was a single-dose study targeting healthy subjects. As a result, no dose-limiting side effects were observed even at the maximum dose that was approximately 10 times higher than the human equivalent dose of the effective dose in the disease mouse model, confirming a high level of tolerability."

P1 data • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease

The First-in-human Study of SRN-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: siRNAgen Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

The First-in-human Study of SRN-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: siRNAgen Therapeutics Inc. | Trial completion date: Mar 2024 ➔ Aug 2024

Trial completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

The First-in-human Study of SRN-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: siRNAgen Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Bioneer subsidiary Cernagen Therapeutics begins phase 1 clinical trial administration of SRN-001, a treatment for pulmonary fibrosis [Google translation] (Maekyung Media Group) - "Bioneer announced...that its subsidiary Cernagen Therapeutics (Cernagen), which specializes in new drugs, completed the first administration of the first dose in the phase 1 clinical trial of SRN-001 for idiopathic pulmonary fibrosis (IPF) on the 8th. Cernagen will complete Phase 1a 4 clinical trials in Australia by the end of the year, and based on the results report, will submit to the U.S. Food and Drug Administration (FDA) next year for Phase 1 (1b) repeated administration clinical trials and Phase 2 initial clinical trials targeting patients with idiopathic pulmonary fibrosis (IPF)."

Trial completion date • Trial status • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology

Bioneer subsidiary Cernagen, pulmonary fibrosis new drug SRN-001 approved for phase 1 clinical trial in Australia [Google translation] (Maekyung Media Group) - "Surnagen Therapeutics, a subsidiary of Bioneer, will begin a phase 1 clinical trial in Australia this month for SRN-001, which is being developed as a new treatment for lung, kidney, and liver fibrosis....the Australian Human Research Ethics Committee (HREC) approved the phase 1 (1a) trial plan for idiopathic pulmonary fibrosis (IPF)...Cernagen completed clinical trial 1a by the end of the year at CMAX, an Australian clinical trial institution, and based on the report, it is scheduled to undergo repeated administration phase 1 (1b) and initial phase 2 clinical trial (2a) for patients with the US Food and Drug Administration (FDA) next year."

New P1 trial • New P2a trial • Trial completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

The First-in-human Study of SRN-001 in Healthy Participants (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: siRNAgen Therapeutics Inc.

New P1 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Bioneer, Subsidiary Registered Patent for Fibrosis Treatment Candidates in Japan [Google translation] (Money Today) - "Bioneer...announced on the 26th that its new drug development subsidiary, Sennagen Therapeutics, has recently registered a Japanese patent for a fibrosis drug candidate (SRN-001), which is currently pursuing its first domestic clinical trial. Accordingly, the substance and use patents for SRN-001 will be protected for the next 20 years, and the acquisition of expanded patent rights for drugs will establish a barrier to entry for competitors. Patent registration in other countries around the world is also expected to gain momentum."

Patent • Idiopathic Pulmonary Fibrosis

Bioneer, JP Morgan Healthcare Conference Virtual Meeting Participation [Google translation] (Maekyung Media Group) - "Thernagen Therapeutics, a subsidiary of Bioneer's new drug development, announced...that it will participate in a virtual one-on-one meeting at the JP Morgan Healthcare Conference, the world's largest pharmaceutical and bio investment event, to be held in San Francisco, USA from the 10th to the 13th of next month. Cernagen Therapeutics plans to update the progress of SAMiRNA-AREG, a new drug candidate for fibrosis, and hold a Q&A session through a meeting with global pharmaceutical companies during the conference."

Clinical • Fibrosis • Idiopathic Pulmonary Fibrosis

Bioneer fibrosis new drug clinical preparation, Park Han-oh in an advantageous position for technology export [Google translation] (businesspost.co.kr) - "Bioneer CEO Han-oh Park is planning to enter a phase 1 clinical trial for a fibrosis drug candidate within this year...According to Bioneer on the 16th, it is preparing to apply to the Ministry of Food and Drug Safety for a domestic phase 1 clinical trial of 'SAMiRNA-AREG', a candidate material for fibrosis treatment, within the second half of this year."

New P1 trial • Idiopathic Pulmonary Fibrosis • Respiratory Diseases