REG - Shield Therapeutics - Enrollment in Phase II Clinical Trial for ACCRUFeR

Shield TherapeuticsAnnouncement

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RNS Number : 9946B  Shield Therapeutics PLC  27 April 2026

Shield Therapeutics plc

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

 

 Enrollment commenced in Phase II Clinical Trial for ACCRUFeR® (Ferric
Maltol) in Japan.

 

London, UK, 27 April 2026: Shield Therapeutics plc (LSE: STX), a
commercial-stage pharmaceutical company specialising in iron deficiency,
announces that its partner, MEDLEAP Pharma, a subsidiary of Vital KSK Holdings
Inc. has confirmed its first patient enrollment for the Phase II clinical
trial for ACCRUFeR® (ferric maltol), a new drug candidate for Pulmonary
Arterial Hypertension (PAH), for patients in Japan.

 

This clinical trial is an exploratory study intended to support a planned
Phase III trial. It follows the Pharmaceuticals and Medical Devices Agency's
(PMDA) confirmation of the development plan for the drug as a PAH treatment in
Japan, based on the drug's prior clinical results from trials in Europe, the
UK, and the USA.

 

Trial Details:

 

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

Target Disease:                 Pulmonary Arterial
Hypertension

Trial Location:                   Japan

 

Anders Lundstrom, CEO of Shield, commented: "Shield is pleased to see the
continued progress being made by our partner MEDLEAP Pharma as they advance
the Japanese clinical program for ACCRUFeR® in this exciting new indication.
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. We are proud to
be working alongside MEDLEAP Pharma on this journey and remain confident in
the potential of ACCRUFeR® to make a real difference in this new therapeutic
area."

 

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
 https://shieldtherapeutics.com/link/egGLRe
 (https://shieldtherapeutics.com/link/egGLRe)

 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 #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 patients suffering from iron deficiency, with or without anemia..
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. to include pediatric patients 10 years of age
and older 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., to include pediatric patients 12 years of age and older
and also have marketing rights in Australia and New Zealand. FeRACCRU® is
also commercialised in Canada by Kye Pharmaceuticals Inc. 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, and with Medleap Pharma Company Limited, a subsidiary of VITAL-NET Inc.
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 fully owned subsidiary of
VITAL-NET, INC. which focuses on pharmaceutical research and development.

 

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

 

 

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