Shield Therapeutics (NASDAQ:STX) reported that MEDLEAP Pharma has enrolled the first patient in an exploratory Phase II clinical trial of ACCRUFeR® (ferric maltol) in pulmonary arterial hypertension in Japan.
Shield is a commercial-stage pharmaceutical company specialising in iron deficiency and holds licensing arrangements for ACCRUFeR, with MEDLEAP running the Japanese clinical programme following the PMDA's confirmation of the development plan based on prior data from Europe, the UK and the USA.
Shield says the Phase II is intended to generate evidence to support a planned Phase III trial, with MEDLEAP-described in the announcement as a subsidiary of VITAL‑NET, Inc.—leading development and Shield providing the compound and existing clinical data.
The trial is titled "An Exploratory Phase II Study to Evaluate the Efficacy and Safety of Ferric Maltol in Patients with Pulmonary Arterial Hypertension" and is being conducted in Japan.
"This is a meaningful step forward, not only for our partnership, but for the patients in Japan who may one day benefit from this treatment," Anders Lundstrom, CEO, said.
