RXC008 / Redx - LARVOL DELTA

RXC008: FIRST-IN-CLASS GASTROINTESTINAL-TARGETED POTENT PAN-ROCK INHIBITOR FOR TREATMENT OF FIBROSTENOTIC CROHN'S DISEASE (UEGW 2026) - No abstract available

Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Skye Bioscience and Redx Pharma Announce Transaction Agreement and $125 Million in Financings (The Manila Times) - "Under the Transaction Agreement, Skye will acquire the entire issued share capital of Redx via a scheme of arrangement (the 'Scheme of Arrangement') under Part 26 of the U.K. Companies Act 2006 (the 'Transaction')...The boards of directors of both companies have unanimously approved the Transaction, with an expected close in Q4 2026, subject to certain closing conditions, as outlined below....Upon completion of the Transaction, the combined company’s cash and cash equivalents balance, including the funds from the Financing, is expected to fund Fibrx’s operations into 2029 and through key clinical milestones, including topline data from the RXC008 Phase 2 clinical study, expected in H2 2028....RXC007 has completed a successful signal searching Phase 2 clinical program in idiopathic pulmonary fibrosis (IPF) patients and is a candidate for partnering."

Enrollment closed • M&A • New P2 trial • P2 data • Crohn's disease • Idiopathic Pulmonary Fibrosis • Immunology

Redx Pharma’s RXC008 gets FDA fast track for Crohn’s disease (Investing.com) - "RXC008 completed a Phase 1 study that showed tolerability and tissue exposure with no clinically relevant breakthrough or hypotension observed. No serious adverse events were reported in the study. The company plans to commence a Phase 2 study later this year. Redx has been working with the FDA and the STAR consortium to define the regulatory pathway for the disease."

Fast track • New P2 trial • Crohn's disease

RXC008 A PROMISING POTENTIAL NEW GASTROINTESTINAL-RESTRICTED ROCK INHIBITOR THERAPY FOR THE MANAGEMENT OF FIBROSTENOSIS IN CROHN'S DISEASE (DDW 2025) - "Six cohorts of 6 participants were randomised and dosed in the SAD part of the study and 3 cohorts of 8 participants in the MAD. There were no safety concerns at any doses with no serious adverse events (SAEs) or discontinuations due to AEs and all adverse events (AEs) being mild or moderate. No cardiovascular effects were observed at any dose as determined by 24 hour blood pressure monitoring and telemetry."

Cardiovascular • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Redx Pharma’s RXC008 shows promise in Phase 1 trial for Crohn’s disease (Investing.com) - P1 | N=NA | "Redx Pharma Limited...has reported positive Phase 1 trial results for RXC008, a drug candidate targeting fibrostenotic Crohn’s disease....The Phase 1 study involved both single ascending dose (SAD) and multiple ascending dose (MAD) trials, with doses ranging from 10mg to 1000mg for SAD and up to 300mg for MAD over 14 days. The trial demonstrated no serious adverse events or treatment discontinuations. Moreover, the drug showed promising intestinal tissue exposure and target engagement, with efficacious concentrations detected in ileum and colon tissue samples from healthy participants."

P1 data • Crohn's disease

Redx announces presentation of positive Phase 1 results from clinical trial with RXC008, a potential first-in-class treatment for fibrostenotic Crohn’s disease (Redx Pharma) - P1 | N=NA | "A Phase 2 study is being planned for H2 2025....Redx Pharma...today announces the presentation of results from a RXC008 Phase 1 clinical trial by lead investigator, Dr Florian Rieder...at the 20th Congress of European Crohn’s and Colitis Organisation Conference (ECCO), Friday February 21, 2025, Berlin, Germany....The study demonstrated that RXC008 was well tolerated with no safety signals at any tested dose (up to 1000mg as a single oral dose and up to 300mg dosed daily over 14 days) with no adverse events (AEs) reported in the single ascending dose (SAD) study. In the multiple ascending dose (MAD) study, all AEs were mild or moderate with no trends observed."

New P2 trial • P1 data • Crohn's disease

RXC008, a first-in-class gastrointestinal restricted pan-ROCK inhibitor developed for treatment of intestinal fibrosis shows GI restriction and tolerability: Results from the phase 1 program in healthy participants. (ECCO-IBD 2025) - "We confirmed the GI restricted nature of the compound with robust tissue exposure and no clinically relevant systemic exposure. RXC008 is a promising treatment for patients with fibrostenotic Crohn’s disease and planning for a Phase 2 study is ongoing."

Clinical • P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease

RXC008: FIRST-IN-CLASS GASTROINTESTINAL-TARGETED POTENT PAN-ROCK INHIBITOR FOR TREATMENT OF FIBROSTENOTIC CROHN’S DISEASE (UEGW 2024) - "RXC008 suppresses fibrosis in animal models of colitis and is being developed as a novel first-in-class therapy to inhibit fibrotic stricture formation in patients with Crohn’s Disease. A first-in-human clinical trial (ISRCTN82038982) commenced in February 2024 and will include assessment of T853-pMYPT1 in tissue biopsy samples for target engagement."

Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Hypotension • Immunology • Inflammatory Bowel Disease • COL1A1 • HAP1 • ROCK1 • TGFB1

Redx Pharma achieves milestone with dosing of first participant in Phase 1 clinical trial for RXC008 (Yahoo Finance) - "Redx Pharma PLC (AIM:REDX) CEO Lisa Anson discusses the enrollment of the first participant in its RXC008 Phase 1 clinical trial in an interview with Proactive's Stephen Gunnion....The next steps for the RXC008 programme include escalating doses in healthy volunteers, with plans to move into patient trials towards the end of the year. Additionally, Anson mentioned Redx Pharma's broader portfolio, noting that RXC008 is the sixth molecule from Redx to enter clinical trials, showcasing the company's drug discovery prowess."

Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease

Redx Pharma: First Participant Dosed in Phase 1 Clinical Trial for RXC008 (Firstwordpharma Press Release) - "Redx...today announces that the first participant has been dosed in a Phase 1 clinical trial for RXC008. RXC008 is a wholly-owned gastro-intestinal (GI) targeted Rho Associated Coiled-Coil Containing Protein Kinase (ROCK) inhibitor, being developed as a potential first-in-class treatment for patients with fibrostenotic Crohn's disease. The primary objective of this first-in-human study is to evaluate the safety and pharmacokinetic (PK) profile of the drug and it is expected that results from the healthy volunteer cohorts will be available by the end of 2024."

P1 data • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease

Redx to Present Poster on the Potential of RXC008 in Crohn’s Disease at the Inammatory Bowel Disease Nordic Conference (Market Screener) - "Redx...announces that it will present a poster on the effect of RXC008 in supressing brosis and tissue injury in pre-clinical models of Crohn's disease at the Inflammatory Bowel Disease Nordic (IBD Nordic) Conference (23-25 November 2022, Malmo Sweden)....The poster at IBD Nordic will present results from adoptive transfer and chronic dextran sulphate sodium (DSS) modelling studies which show that RXC008 can suppress brosis and attenuate tissue injury in animal models of GI-brosis and has the potential to be developed as a novel therapy to inhibit brotic stricture formation in Crohn's disease....Redx's third drug candidate, RXC008, a GI-targeted ROCK inhibitor for the treatment of brostenotic Crohn's disease, is currently in pre-IND stage, with Phase 1 clinical studies expected to commence in 2023."

New P1 trial • Preclinical • Crohn's disease • Immunology • Inflammatory Bowel Disease

IN BRIEF: Redx Pharma to start new Crohn's disease study in late 2023 (Morningstar UK) - "Redx Pharma PLC - Cheshire-based cancer and fibrosis drug developer - Announces end of 2023 as start of phase 1 studies for its Crohn's disease clinical development candidate RXC008. The inhibitor is designed to act exclusively in the gastrointestinal tract at the site of fibrosis in Crohn's disease patients....The company adds: 'This programme will be the third development candidate that Redx has progressed in the area of fibrosis.'"

New P1 trial • Crohn's disease • Immunology • Inflammatory Bowel Disease