Peptron's Brain Disease Treatment 'Prisendin' Receives IND Approval for Phase 3 Clinical Trial in Australia Following the UK

[Asia Economy Reporter Lee Gwan-joo] Peptron announced on the 6th that it has received approval for the Phase 3 clinical trial plan (IND) of the cerebrovascular treatment drug 'Presendin,' jointly developed with Invex, from the Australian Human Research Ethics Committee (HREC) and the Therapeutic Goods Administration (TGA).

Idiopathic Intracranial Hypertension (IIH) is a disease characterized by severe headaches, vision loss, and tinnitus caused by increased intracranial pressure, which in severe cases compresses the optic nerve and can lead to blindness. Currently, there is no treatment, and patients rely on surgery to reduce intracranial pressure or symptom-relieving drugs, but their effectiveness has been very limited.

Professor Sinclair of the University of Birmingham, UK, Chief Scientific Officer of Invex, stated, "IIH most commonly occurs in obese women in their 20s and 30s and is a disease characterized by optic nerve compression and severe intracranial pressure. The incidence has increased by more than 350% over the past decade. However, there has been no clear treatment for IIH so far. We believe that successfully conducting this large-scale randomized controlled clinical trial will improve the quality of life for patients suffering from IIH."

Presendin has previously received approval for a Phase 3 clinical trial plan in the UK as well. A Peptron official said, "Following the UK, entering clinical trials in Australia is expected to continuously increase revenue from the supply of clinical pharmaceuticals by Peptron," adding, "As global countries continue to approve clinical trials for Presendin, we plan to cooperate closely with Invex to advance into the US FDA clinical trials."

This content was produced with the assistance of AI translation services.