zelasudil (RXC007) / Redx - LARVOL DELTA

Phase 2a signal searching study with zelasudil in idiopathic pulmonary fibrosis (IPF) (ERS 2025) - No abstract available

P2a data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Role of ROCK2 inhibitors in the Treatment of Chronic Graft-versus-Host disease. (PubMed, Expert Opin Investig Drugs) - "This includes a review of the current and ongoing clinical data with belumosudil, and an overview of current ROCK2 inhibitors in development for cGVHD including rovadicitinib, zelasudil and GV-101. Many of the recent novel agents with unique mechanisms such as ROCK2 inhibitors (i.e. belumosudil) provide high response rates but rarely yield complete responses in cGVHD. The future of management of cGVHD will rely on investigating combination therapy upfront that may achieve deeper complete responses, developing newer preventative therapies, and advancements in biomarker detection/risk stratification for cGVHD."

Journal • Review • Chronic Graft versus Host Disease • Fibrosis • Graft versus Host Disease • Immunology • Transplantation

RXC007 0002: Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Redx Pharma Plc | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2 | Trial completion date: Jun 2024 ➔ Jan 2025

Enrollment closed • Phase classification • Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Combining zelasudil, a small molecule ROCK2 inhibitor, with chemotherapy or immunotherapy improves response in preclinical models of pancreatic cancer (AACR 2024) - P2a | "Here, we investigate the benefit of combining an anti-fibrotic, RXC007, with either standard of care chemotherapy or immunotherapy in mouse models of PDAC.In a fibrotic patient-derived metastatic PDAC orthotopic model, RXC007 (10mg/kg, 50mg/kg and 100mg/kg BID 5d on/2d off PO) in combination with SoC chemotherapy Gemcitabine (100mg/kg IP QW)/Abraxane (30 mg/kg IP QW) improved survival in a dose-dependent manner (all P<0.0001) compared to Gemcitabine/Abraxane alone.In the immunocompetent orthotopic LSL-KrasG12D/+; LSL-Trp53R172H/+; Pdx1-Cre (KPC) model of metastatic PDAC, survival was significantly increased (P<0.0001) upon treatment with a combination of RXC007 (50 mg/kg BID 5d on/2d off PO) and anti-PD1 (200 ug BIW) compared to anti-PD1 alone. ROCK2 inhibition elicited positive immunomodulatory effects in KPC pancreatic tumors, with increase of CD8+ (P=0.0031) and CD4+ (P=0.008) T cell infiltrate into the tumor cortex and reduction in immunosuppressive..."

Preclinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CD4 • CD8 • FOXP3 • KRAS • PDX1

Redx to Present Additional Preclinical Efficacy of RXC007 and DDR1/2 Inhibitors in CancerAssociated-Fibrosis Models at the Resistant Tumour Microenvironment, Keystone Symposia (Market Screener) - "Redx...announces additional preclinical data from the company's fibrosis portfolio including data on lead asset RXC007, and Discodin Domain Receptor (DDR) 1/2 inhibitors will be presented both orally and in a poster, at The Resistant Tumour Microenvironment, Keystone Symposia (7-10 May 2022, Vancouver, BC, Canada)...Data presented will be from the Company's lead fibrosis asset, RXC007 as well as the DDR discovery programme....In addition to Dr Wilcock's presentation, Redx will present a poster which details the potential of RXC007 in an aggressive patient derived xenograft model of PDAC in combination with standard of care (SoC) chemotherapy, and DDR1/2 inhibition in a TNBC model in combination with anti-PD-1...A Phase 2a study assessing RXC007 as a potential treatment for patients with idiopathic pulmonary fibrosis (IPF) is expected to report topline data in Q1 2024."

P2a data • Preclinical • Breast Cancer • Gastrointestinal Cancer • Idiopathic Pulmonary Fibrosis • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Respiratory Diseases • Triple Negative Breast Cancer

A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=90 | Completed | Sponsor: Redx Pharma Plc | Recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Mar 2023 | Trial primary completion date: Dec 2021 ➔ Mar 2023

Trial completion • Trial completion date • Trial primary completion date • Fibrosis • Hepatology • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Nephrology • Non-alcoholic Steatohepatitis • Pulmonary Disease • Renal Disease • Respiratory Diseases

Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2a | N=64 | Recruiting | Sponsor: Redx Pharma Plc | Trial primary completion date: Dec 2023 ➔ Apr 2024

Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Redx Pharma says RXC007 has received orphan drug designation from the US FDA (Market Screener) - "Redx Pharma PLC said Monday that its drug RXC007 has been granted orphan drug designation by the US Food & Drug Administration for the treatment of idiopathic pulmonary fibrosis, a condition that causes breathing difficulties due to scarring of the lungs....Redx said RXC007 is currently undergoing a phase 2a clinical trial for the treatment of IPF, with results expected in the first quarter of 2024."

Orphan drug • P2a data • Idiopathic Pulmonary Fibrosis • Pulmonary Disease • Respiratory Diseases

Orphan Designation: Treatment of Idiopathic Pulmonary Fibrosis (FDA) - Date Designated: 08/14/2023

Orphan drug • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P2a | N=64 | Recruiting | Sponsor: Redx Pharma Plc

New P2a trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

"#Redx to Present Additional Preclinical Efficacy of #RXC007 and #DDR1/#DDR2 Inhibitors in #CancerAssociatedFibrosis Models at The Resistant #TumourMicroenvironment, #KeystoneSymposia $REDX https://t.co/RE8EWMOEE8" (@1stOncology)

Preclinical • Tumor microenvironment • Fibrosis • Oncology • DDR1 • DDR2

Redx, Jounce announce recommended business combination (ExpressPharma) - "Redx Pharma and Jounce Therapeutics announce an unanimously recommended Business Combination of the two companies via a proposed all share merger transaction. Redx is a clinical-stage biotechnology company focused on the discovery and development of novel, small molecule, targeted therapeutics for the treatment of cancer and fibrotic diseases and the emerging area of cancer-associated fibrosis. Jounce is a clinical-stage immunotherapy company developing therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients through a biomarker approach. The Business Combination will create a transatlantic organisation with proven expertise in both small molecule drugs and biologics, and a clinical pipeline with multiple value inflection points in the near and medium term."

M&A • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Redx Pharma says recruitment for phase IIa study of fibrosis drug underway in five European countries (Proactiveinvestors) - "Redx Pharma...expects to have top-line clinical data from a phase IIa study of its fibrosis candidate in the first quarter of next year as it said patient recruitment was underway in five countries across Europe...Regulatory and ethics approvals for both the 28-day and 12-week groups have been received in five European countries, and patient recruitment is underway at multiple study sites. Meanwhile, US enrolment into the 28-day translational science sub-study has begun, but the 12-week cohorts are under a partial clinical hold by the US Food & Drug Administration (FDA) pending additional non-clinical data later this year. 'We anticipate topline data from both the 12-week and 28-day cohorts to be available in the first quarter of 2024.'"

P2a data • Trial status • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

RXC007: Topline data from P2a trial (NCT05570058) for IPF in H2 2023 (Redx Pharma) - FY2022 Results

P2a data • Idiopathic Pulmonary Fibrosis

Redx Pharma looks forward to phase II trial results in 2023 (Proactiveinvestors) - "Redx Pharma PLC...said its recent fundraising has given it a cash runway into 2024 as it released results showing revenues also grew strongly in the year to end-September 2022. The biotech has two drugs going through phase II clinical trials this year,..RXC007 for idiopathic pulmonary fibrosis (IPF)....'Importantly, given the current economic and market backdrop, during the period we were also able to raise significant additional capital to bolster our balance sheet. This provides us with a cash runway into 2024 that will allow us to deliver multiple value-inflection points'....Revenues for the year rose to £18.7mln (H1 2021: £10mln) including milestone payments of £10.7mln with research awards and services chipping in £8mln (H1 2021: £5mln). Losses for the year were reduced to £18mln (H1 2021: £21mln) even though R&D expenditure rose to £34.4mln (H1 2021: £21.5mln)."

Commercial • Idiopathic Pulmonary Fibrosis

RXC007, a Potent, Highly Selective ROCK2 Inhibitor, Demonstrates Preclinical Efficacy Across Fibrosis Models and Good Phase 1 Safety Profile, Supporting Development in IPF and ILD (ICLAF 2022) - "It has shown increased expression and activation in Idiopathic Pulmonary Fibrosis (IPF) making it a potential target for IPF treatment.In rat and mouse therapeutic and prophylactic models of bleomycin-induced lung fibrosis, RXC007 demonstrated suppression of fibrosis and collagen deposition. No food effect on exposure was observed.The anti-fibrotic effects in both rodent and human IPF tissue and the well tolerated safety profile of the compound support exploration of the potential of RXC007 in the treatment of IPF. A Phase 2a study in IPF patients is planned to open later in 2022."

P1 data • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • COL1A1 • CTGF • FN1 • MMP7 • SPP1 • TIMP1

Redx Pharma kicks off phase IIa trial of second wholly-owned drug (Proactiveinvestors) - "Redx Pharma...said a second drug from its pipeline has moved into phase II clinical trials following the recruitment of the first patient to its programme.The 12-week study of RXC007 will assess for early signs of efficacy in people with a form of lung scarring called idiopathic pulmonary fibrosis (IPF)....Headline data will be shared with the market in the second half of next year."

P2a data • Trial status • Idiopathic Pulmonary Fibrosis

Redx Pharma to present lead fibrosis asset poster in Iceland (Proactiveinvestors) - "Redx Pharma PLC...will present a poster on its lead fibrosis asset RXC007 at the upcoming International Colloquium on Lung and Airway Fibrosis between October 1-5 in Reykjavik, Iceland.The poster will present RXC007 preclinical efficacy data across fibrosis models and Phase 1 data for single and multiple ascending dose studies in healthy male volunteers....RXC007...which is expected to enter Phase 2a clinical studies for lead indication idiopathic pulmonary fibrosis (IPF) in 2022."

New P2a trial • P1 data • Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis

Effects of RXC007, a highly potent and selective ROCK2 inhibitor, in ex-vivo and in vivo models of pulmonary fibrosis. (ERS 2022) - "RXC007 has been evaluated for anti-fibrotic properties in rodent bleomycin lung models and in human IPF tissue. In human PCLS, pro-fibrotic pathway modulation was observed with strongest modulation observed at 30 µM including the suppression of analytes such as collagen1 (COL1A1) and matrix metalloproteinase 7 (MMP7). RXC007 demonstrates anti-fibrotic effects in both rodent and human IPF tissue and may have the potential to successfully treat IPF patients."

Preclinical • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • COL1A1 • CTGF • FN1 • MMP7

Redx Presents Encouraging Phase 1 Safety Data for RXC007 (Market Screener) - P1 | N=80 | NCT04931147 | Sponsor: Redx Pharma Plc | "Redx...announces encouraging data from the Phase 1 clinical study of its lead fibrosis asset, RXC007, which was presented at the Virtual Interstitial Lung Disease Drug Development (ILD) Summit on 9 March 2022 by Nicolas Guisot PhD, Research Fellow at Redx. Highlights from the data were also presented at the Cowen 42 nd Annual Health Care Conference by Lisa Anson, Chief Executive Officer, on 9 March 2022....The data presented showed RXC007 has an excellent safety and pharmacokinetic profile in both the SAD and multiple dose phase....Based on this profile, Redx confirms plans to commence a staged Phase 2 clinical development program for idiopathic pulmonary fibrosis in 2022."

New P2 trial • P1 data • PK/PD data • Idiopathic Pulmonary Fibrosis

REDX PHARMA PLC - Redx to Present at ILD Summit 2022 (Market Screener) - "Redx...RXC007, at the forthcoming Virtual Interstitial Lung Disease Drug Development (ILD) Summit, 7-9 March 2022. The drug candidate is currently in a Phase 1 healthy volunteer study, with Phase 2 studies for idiopathic pulmonary fibrosis expected to commence later in 2022....The presentation at the ILD Summit will focus on the rationale for ROCK2 inhibition in the treatment of lung fibrosis and its potential to address the current high unmet need. Nicolas will also discuss the development of RXC007 and review the compelling data generated in preclinical studies."

New P2 trial • Preclinical • Idiopathic Pulmonary Fibrosis

"$19m in milestones triggered in December by progress with @AstraZeneca #porcupineinhibitor & @JazzPharma #oncology collaborations. AZD5055 (formerly RXC007) is the 4th clinical asset discovered by @RedxPharma's medicinal chemistry #drugdiscovery platform. #REDX" (@trinity_delta)

Clinical • Oncology

RXC007 for IPF Showing Favorable Safety in Ongoing Phase 1 Trial (Pulmonary Fibrosis News) - P1, N=80; NCT04931147; Sponsor: Redx Pharma Plc; "RXC007...is showing favorable safety and pharmacological properties in an ongoing Phase 1 trial in healthy volunteers....The investigational medicine has shown promise in animal models, as well as in experiments performed on tissue samples from IPF patients....'Existing pharmacological data suggest that, at the higher tested doses, the medicine’s active ingredient is achieving biologically relevant exposures'...A next part, testing multiple increasing doses of the experimental therapy, is expected to open shortly....Assuming Phase 1 data remain positive, Redx plans to start testing RXC007 in a Phase 2 trial in IPF patients next year."

New P2 trial • P1 data • Idiopathic Pulmonary Fibrosis • Respiratory Diseases

Redx Pharma to pocket US$4mln milestone payment from AstraZeneca (Proactiveinvestors) - "Redx Pharma...said it will receive the first ‘milestone payment’ under its early payments agreement with AstraZeneca (LON:AZN) following the pair’s licensing deal last summer....It will receive US$4mln of the US$17mln before the start of clinical trials of Redx-developed RXC006, which is targeting fibrotic diseases including idiopathic pulmonary fibrosis...first-in-human studies on RXC007, its oral ROCK2 inhibitor, which also targets fibrosis started earlier this month."

Commercial • New trial • Idiopathic Pulmonary Fibrosis

A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Redx Pharma Plc

New P1 trial • Fibrosis • Hepatology • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Nephrology • Non-alcoholic Steatohepatitis • Pulmonary Disease • Renal Disease • Respiratory Diseases • PCR