REG - Shield Therapeutics - Initiation of a Phase II Clinical Trial in Japan

Shield TherapeuticsAnnouncement

Today 07:05

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20251114:nRSN5863Ha&default-theme=true

RNS Number : 5863H  Shield Therapeutics PLC  14 November 2025

  Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

 

Initiation of a Phase II Clinical Trial for ACCRUFeR® (Ferric Maltol) for the

Treatment of Pulmonary Arterial Hypertension (PAH) in Japan.

 

London, UK, 14 November 2025 Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency, today
announced that its partner, MEDLEAP Pharma, a subsidiary of Vital KSK Holdings
Inc. has initiated a Phase II clinical trial for ACCRUFER® (ferric maltol), a
new drug candidate for Pulmonary Arterial Hypertension (PAH), for patients in
Japan. This trial is an exploratory study to support a Phase III trial and
follows confirmation by the Pharmaceuticals and Medical Devices Agency (PMDA)
of the development plan for the drug as a PAH treatment in Japan, based on
previous clinical results in Europe, UK and USA.

 

Subject to the results of this trial, MEDLEAP plans to conduct a Phase III
trial (Pivotal Study) and proceed with regulatory submission and launch
preparations from 2028 onwards. MEDLEAP positions this drug as a core pipeline
in the PAH field.

 

Trial Details:

 

Trial Name:                        An Exploratory Phase
2 Study to Evaluate the Efficacy and Safety of Ferric Maltol in Patients with
Pulmonary Arterial Hypertension (PAH)

Target Disease:                 Pulmonary Arterial
Hypertension

Trial Design:                       Multi-center,
randomised, placebo-controlled, double-blind study

Number of Subjects:      Approximately 26 (planned)

Primary Endpoint:           12-week 6-minute walk distance change
from baseline

Secondary Endpoints:    Cardiac function-related efficacy parameters,
safety, tolerability, etc

Trial Location:                   Japan

 

 

Dr Jackie Mitchell, VP of Quality, RA and Clinical Development at Shield,
commented: "Shield is delighted with the rapid progress our partner MEDLEAP
Pharma has made in agreeing a PAH development plan with PMDA and initiating
the Japanese clinical program to develop ACCRUFER for this exciting new
indication."

 

Professor Masaharu Kataoka, Second Department of Internal Medicine, University
of Occupational and Environmental Health, Japan School of Medicine, commented:
"Iron deficiency anemia is highly prevalent in PAH patients and is associated
with various clinical manifestations of PAH, including symptoms, exercise
tolerance, right heart function, and hemodynamic parameters. Therefore,
efficient iron supplementation is recommended. However, existing treatments
face challenges in long-term iron supplementation management due to
gastrointestinal side effects and low absorption efficiency, creating a need
for new therapeutic options. In this context, we look forward to establishing
Japan-originated evidence through clinical trials of Ferric Maltol, a
completely new compound that overcomes these challenges and enables long-term
administration, in PAH patients."

 

For further information please contact:

 

 Shield Therapeutics plc                                                                        www.shieldtherapeutics.com (http://www.shieldtherapeutics.com/)
 Anders Lundstrom, CEO                                                                          +44 (0) 191 511 8500

 Santosh Shanbhag, CFO                                                                          Investorrelations@shieldtx.com

 Stephanie Hicks, Investor Relations

 Nominated Adviser and Joint Broker
 Peel Hunt LLP
 James Steel                                                                                    +44 (0)20 7418 8900

 Joint Broker

 Cavendish Ltd

 Geoff Nash/ Isaac Hooper/Nigel Birks/Harriet
 Ward

                                                                                                +44 (0)20 7220 0500

 

About Iron Deficiency and ACCRUFeR®/FeRACCRU®

Clinically low iron levels (aka iron deficiency, ID) can cause serious health
problems for adults of all ages, across multiple therapeutic areas. Together,
ID and ID with anemia (IDA) affect about 20 million people in the US and
represent a $2.3B market opportunity. As the first and only FDA approved oral
iron to treat ID/IDA, ACCRUFeR® has the potential to meet an important unmet
medical need for both physicians and patients and is now the leading #1
branded prescription oral iron the market today (data source - IQVIA Xponent
PlanTrak).

 

ACCRUFeR®/FeRACCRU® (ferric maltol) is a novel, stable, non-salt-based oral
therapy for adults with ID/IDA. The drug has a novel mechanism of absorption
compared to other oral iron therapies and has been shown to be an efficacious
and well-tolerated therapy in a range of clinical trials. More information
about ACCRUFeR®/FeRACCRU®, including the product label, can be found at:
www.accrufer.com (http://www.accrufer.com/) and www.feraccru.com
(http://www.feraccru.com/) .

 

PAH (Pulmonary Arterial Hypertension) market in 2024 is estimated to be worth
over $230M in Japan. Iron supplementation is strongly recommended for PAH
patients with iron deficiency anemia according to both European and Japanese
guidance (ESC/ERS Guidelines for the diagnosis and treatment of pulmonary
hypertension 2022 and Japan Pulmonary Hypertension and Pulmonary Circulation
Society Guidance 2024) [Recommendation Class I]. (1) Humbert M, et al. 2022
ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.
Eur Respir J. 2023; 61(1):2200879. (2) Japanese Pulmonary Hypertension and
Pulmonary Circulation Society. Pulmonary Hypertension Treatment Guidance2024.

 

About Shield Therapeutics plc

Shield is a commercial stage specialty pharmaceutical company that delivers
ACCRUFeR®/FeRACCRU® (ferric maltol), an innovative and differentiated
pharmaceutical product, to address a significant unmet need for patients
suffering from iron deficiency, with or without anemia. The Company has
launched ACCRUFeR® in the U.S. with an exclusive, multi-year collaboration
agreement with Viatris. Outside of the U.S., the Company has licensed the
rights to five specialty pharmaceutical companies. FeRACCRU® is
commercialised in the UK and European Union by Norgine B.V., which also has
marketing rights in Australia and New Zealand. Shield also has an exclusive
license agreement with Beijing Aosaikang Pharmaceutical Co., Ltd., for the
development and commercialisation of ACCRUFeR®/FeRACCRU® in China, Hong
Kong, Macau and Taiwan, with Korea Pharma Co., Ltd. for the Republic of Korea,
with Kye Pharmaceuticals Inc. for Canada, and with VITAL-NET for Japan.

 

ACCRUFeR®/FeRACCRU® has patent coverage until the mid-2030s.

ACCRUFeR®/FeRACCRU® are registered trademarks of Shield Therapeutics.

 

About MEDLEAP PHARMA COMPANY LIMITED

MEDLEAP PHARMA COMPANY LIMITED ("MEDLEAP") is a subsidiary of VITAL_NET, INC.
which will focus on pharmaceutical research and development. This subsidiary
is fully owned by Vital KSK Holdings and will be led by Yuichi Kobayashi, an
executive officer of the parent company.

 

Under its philosophy of "Bringing innovation to Japan's medical future through
the creation of original pharmaceuticals," contributes to reducing drug lag in
Japan through new drug introduction support business, delivering a healthy
future to patients and their families. MEDLEAP promotes competitive new drug
creation through collaboration with domestic and international research
institutions and companies.

 

Headquarters:                   3-3-1 Yaotome, Izumi-ku,
Sendai City, Miyagi Prefecture 981-3112

Representative:               President and CEO Yuichi Kobayashi

Established:                        September 2025

Business Activities:          Research, development, manufacturing,
and sales of pharmaceuticals

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  MSCGZMMMNDZGKZG



            Copyright 2019 Regulatory News Service, all rights reserved