TIDMREDX
Redx Pharma plc
21 August 2023
REDX PHARMA PLC
("Redx" or the "Company")
Zelasudil granted FDA Orphan Drug Designation
Alderley Park, UK, 21 August 2023 Redx (AIM:REDX), the
clinical-stage biotechnology company focused on discovering and
developing novel, small molecule, targeted therapeutics for the
treatment of fibrotic disease and cancer announces that zelasudil
(RXC007), an oral, selective Rho Associated Coiled-Coil Containing
Protein Kinase 2 (ROCK2) inhibitor, has received Orphan Drug
Designation from the US Food and Drug Administration (FDA) for the
potential treatment of Idiopathic Pulmonary Fibrosis (IPF).
Zelasudil is currently in a Phase 2a clinical study for IPF, with
topline data expected in Q1 2024.
The FDA can grant Orphan Drug Designation to support the
development and evaluation of new treatments to prevent, diagnose
or treat a rare disease or condition that affects fewer than
200,000 in the US. The designation provides Redx with various
development and commercial incentives, including market
exclusivity, in order to address this unmet need for patients
suffering from IPF .
Dr Jane Robertson, Chief Medical Officer, Redx Pharma commented:
"We are delighted that the FDA has recognised the potential of
zelasudil for the treatment of IPF and granted Orphan Drug
Designation. Selectively targeting ROCK2 is an exciting, novel
approach which could provide a new treatment option for patients
with IPF, and with potential applications in other interstitial
lung diseases and cancer-associated fibrosis. We are encouraged by
both the strength of our preclinical package as well as the
clinical results to date and we look forward to reporting Phase 2a
topline data in Q1 2024."
About zelasudil (RXC007)
Zelasudil is an orally available, highly selective small
molecule inhibitor that targets ROCK2 which sits at a nodal point
in a cell signalling pathway, believed to be central to fibrosis.
ROCK2 selectivity is important to avoid systemic hypotension, a
serious cardiovascular side effect which has been seen in product
candidates that systemically inhibit both ROCK1 and ROCK2. As a
selective ROCK2 inhibitor zelasudil, has the potential to treat
several fibrotic diseases and has demonstrated robust anti-fibrotic
effects in a range of industry-standard in vivo preclinical models,
results of which were presented at the International Colloquium on
Lung and Airway Fibrosis (ICLAF) and the Antifibrotic Drug
Development Summit (AFDD) in 2022. Redx is evaluating zelasudil
initially as a treatment for IPF, a severe and life-threatening
chronic lung condition with limited treatment options.
About IPF
IPF is a debilitating disease of the lungs which progressively
causes scarring and a reduction in lung function. Occurring
primarily in older adults (>50 years old), it involves
irreversible and variable scarring, stiffening, and thickening of
the lung tissues, leading to patients experiencing shortness of
breath and lack of oxygen absorption. Over 170,000 patients suffer
with IPF[1] and around a further 53,000 people are diagnosed each
year (US, 5 EU, Japan). Patients diagnosed with IPF have an
estimated life expectancy of 3 to 5 years[2]. There is no known
cure and current treatment only slows progression of the
disease.
For further information,
please contact:
Redx Pharma Plc T: +44 (0)1625
UK Headquarters 469 918
Caitlin Pearson, Head of Communications
ir@redxpharma.com
Lisa Anson, Chief Executive
Officer
US Office
Peter Collum, Chief Financial
Officer
SPARK Advisory Partners (Nominated T: +44 (0)203
Adviser) 368 3550
Matt Davis/ Adam Dawes
WG Partners LLP (Joint Broker) T: +44 (0)203
705 9330
Claes Spång/ Satheesh Nadarajah/
David Wilson
Panmure Gordon (UK) Limited T: +44 (0)207
(Joint Broker) 886 2500
Rupert Dearden/ Freddy Crossley/
Emma Earl
FTI Consulting T: +44 (0)203
727 1000
Simon Conway/ Ciara Martin
About Redx Pharma Plc
Redx Pharma (AIM: REDX) is a clinical-stage biotechnology
company focused on the discovery and development of novel, small
molecule, targeted therapeutics for the treatment of fibrotic
disease, cancer and the emerging area of cancer-associated
fibrosis, aiming initially to progress them to clinical proof of
concept before evaluating options for further development and
potential value creation. The Company's lead fibrosis product
candidate, the selective ROCK2 inhibitor, zelasudil (RXC007), is in
development for interstitial lung disease and commenced a Phase 2a
trial for idiopathic pulmonary fibrosis (IPF) in October 2022, with
topline data expected in Q1 2024. Redx's lead oncology product
candidate, the Porcupine inhibitor RXC004, being developed as a
targeted treatment for Wnt-ligand dependent cancers, is expected to
report combination with anti-PD-1 Phase 2 data during 2023. Redx's
third drug candidate, RXC008, a GI-targeted ROCK inhibitor for the
treatment of fibrostenotic Crohn's disease, is progressing towards
a CTA application at the end of 2023.
The Company has a strong track record of discovering new drug
candidates through its core strengths in medicinal chemistry and
translational science, enabling the Company to discover and develop
differentiated therapeutics against biologically or clinically
validated targets. The Company's accomplishments are evidenced not
only by its two wholly-owned clinical-stage product candidates and
rapidly expanding pipeline, but also by its strategic transactions,
including the sale of pirtobrutinib (RXC005, LOXO-305), a
non-covalent (reversible) BTK inhibitor now approved by the US FDA
for adult patients with mantle cell lymphoma previously treated
with a covalent BTK inhibitor, and AZD5055/RXC006, a Porcupine
inhibitor targeting fibrotic diseases including IPF, which
AstraZeneca is progressing in a Phase 1 clinical study. In
addition, Redx has forged collaborations with Jazz Pharmaceuticals,
which includes JZP815, a pan-RAF inhibitor developed by Redx which
Jazz is now progressing through Phase 1 clinical studies, and an
early stage oncology research collaboration.
To subscribe to Email Alerts from Redx, please visit:
www.redxpharma.com/investor-centre/email-alerts/ .
[1] Patient numbers (diagnosed prevalence) & market size
forecast data sourced from Global Data (US, EU5, Japan)
[2] Clinical Estimates from Hyun 2015, Ley 2012, Raghu 2006
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