RCS - Redx Pharma plc - Zelasudil granted FDA Orphan Drug Designation

Redx PharmaAnnouncement

21/08/2023 07:00

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RNS Number : 8443J  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 469 918

 UK Headquarters

 Caitlin Pearson, Head of Communications

 ir@redxpharma.com (mailto:ir@redxpharma.com)

 Lisa Anson, Chief Executive Officer

 US Office

 Peter Collum, Chief Financial Officer

 SPARK Advisory Partners (Nominated Adviser)                          T: +44 (0)203 368 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 (Joint Broker)                           T: +44 (0)207 886 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/
(http://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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