HLX-1502 / Healx - LARVOL DELTA

INSPIRE-NF1: A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1 (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Healx Limited | Trial completion date: Aug 2027 ➔ Jan 2028 | Trial primary completion date: Jul 2026 ➔ Dec 2026

Trial completion date • Trial primary completion date • Genetic Disorders • Neurofibromatosis • Solid Tumor

Healx Announces First Patient Dosed in Phase 2 Trial Evaluating HLX-1502 for the Treatment of Neurofibromatosis Type 1 (Businesswire) - "Healx...announced the first patient has been dosed in INSPIRE-NF1, a Phase 2 trial evaluating the safety and efficacy of HLX-1502, an oral investigational therapy, in patients with neurofibromatosis type 1 (NF1)."

Trial status • Neurofibromatosis

INSPIRE-NF1: A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients with Neurofibromatosis Type 1 (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Healx Limited | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2027 ➔ Aug 2027 | Initiation date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: May 2027 ➔ Jul 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Genetic Disorders • Neurofibromatosis • Solid Tumor

Healx Announces $47 million Series C Financing and FDA Clearance of Phase 2 IND for Neurofibromatosis Type 1 Trial (Businesswire) - "Healx...announced it has raised $47 million in a Series C round...Proceeds of the financing will be used to advance the company’s pipeline of medicines in rare oncology, renal and neurodevelopmental disorders, including advancing its lead program HLX-1502 through a Phase 2 clinical trial for the treatment of neurofibromatosis Type 1 (NF1)...Healx also announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to proceed with its Phase 2 clinical trial of HLX-1502. This trial will focus on treating adults with NF1 and inoperable plexiform neurofibroma."

Financing • IND • New P2 trial • Genetic Disorders • Neurofibromatosis • Oncology

INSPIRE-NF1: A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1 (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Healx Limited

New P2 trial • Genetic Disorders • Neurofibromatosis • Solid Tumor

Healx’s HLX-1502 awarded US orphan drug designation for neurofibromatosis type 1 (Bioworld) - "The FDA has awarded orphan drug designation to Healx Ltd.’s HLX-1502 for the treatment of neurofibromatosis type 1 (NF1). HLX-1502, discovered through the company’s proprietary artificial intelligence (AI) drug discovery platform, has a first-in-class mechanism and supporting data that indicate the potential for a good safety profile."

Orphan drug • Neurofibromatosis • Oncology