Dekavil (F8-IL10) / Pfizer, Philogen - LARVOL DELTA

A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX (clinicaltrials.gov) - P2 | N=27 | Terminated | Sponsor: Philogen S.p.A. | Active, not recruiting ➔ Terminated; Approvals of new agents for the same indication have significantly slowed down the recruitment in this trial making the prosecution of the present investigation extremely difficult.

Trial termination • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL17A • IL18 • IL2 • IL22 • IL6 • MMP3

A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX (clinicaltrials.gov) - P2 | N=27 | Active, not recruiting | Sponsor: Philogen S.p.A. | Trial completion date: Dec 2022 ➔ Jun 2023

Trial completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL17A • IL18 • IL2 • IL22 • IL6 • MMP3

DekaJoint: Safety and Preliminary Signs of Efficacy of F8IL10 for Intra-articular Treatment (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: Philogen S.p.A.

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Randomized, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Efficacy of F8IL10 (Dekavil) in Patients With Active RA Receiving MTX (clinicaltrials.gov) - P2 | N=27 | Active, not recruiting | Sponsor: Philogen S.p.A. | Recruiting ➔ Active, not recruiting | N=87 ➔ 27 | Trial completion date: Apr 2018 ➔ Dec 2022

Enrollment change • Enrollment closed • Trial completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • IL17A • IL18 • IL1B • IL2 • IL22 • IL6 • MMP3 • TNFA

Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. (clinicaltrials.gov) - P2a; N=20; Terminated; Sponsor: Pfizer; Trial completion date: Jul 2021 ➔ Jan 2021; Active, not recruiting ➔ Terminated; Trial primary completion date: Jul 2021 ➔ Jan 2021; The Sponsor changed R&D strategy and priority.

Clinical • Trial completion date • Trial primary completion date • Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • IL10

Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease (clinicaltrials.gov) - P1b; N=0; Withdrawn; Sponsor: Pfizer; Suspended ➔ Withdrawn

Clinical • Trial withdrawal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. (clinicaltrials.gov) - P2a; N=20; Active, not recruiting; Sponsor: Pfizer; Recruiting ➔ Active, not recruiting; N=76 ➔ 20

Clinical • Enrollment change • Enrollment closed • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis and Crohn's Disease (clinicaltrials.gov) - P1b; N=5; Suspended; Sponsor: Pfizer; Trial completion date: Mar 2021 ➔ Feb 2022; Trial primary completion date: Mar 2021 ➔ Feb 2022

Clinical • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. (clinicaltrials.gov) - P2a; N=98; Recruiting; Sponsor: Pfizer; N=68 ➔ 98

Enrollment change • Biosimilar • Immunology • Inflammation • Inflammatory Bowel Disease

A phase Ib clinical trial in rheumatoid arthritis of dekavil (F8-IL10), a novel anti-inflammatory immunocytokine (EULAR 2014) - Presentation time: 14.06.2014, 10:15; Abstract #SAT0232; P1, N=20; NCT02076659; Sponsor: Philogen S.p.A; "Considering the maximum ACR response achieved: three patients achieved an ACR 70 response, three patients achieved an ACR 50 response and six patients achieved an ACR20 response at various time points during regular or extended follow-up...Of note stand out two patients in the 30 µg/kg cohort and in the 60 µg/kg cohort who achieved long-lasting remission: ACR70s at week 60 (Patient 8) and week 44 (Patient 11), still on-going."

P1 data • Rheumatoid Arthritis

A phase Ib clinical trial with dekavil (F8-IL10), an anti-inflammatory immunocytokine for the treatment of rheumatoid arthritis, used in combination with methotrexate (EULAR 2012) - Presentation time: 08.06.2012; 11:45; Anticipated presentation at EULAR 2012

Anticipated P1 data presentation • Rheumatoid Arthritis

A phase Ib clinical trial with Dekavil (F8-IL10), an anti-inflammatory immunocytokine for the treatment of rheumatoid arthritis, used in combination with methotrexate (EULAR 2012) - P1b, N= NA; The clinical trial is still on-going and has so far confirmed the excellent tolerability of DEKAVIL at the doses used; These safety data are in line with the ones which had previously been established for IL10 in patients with rheumatoid arthritis

Trial update • Rheumatoid Arthritis

Fibroblast-like synovial cell production of extra domain A fibronectin associates with inflammation in osteoarthritis. (PubMed, BMC Rheumatol) - "Fibronectin containing the ED-A domain is currently being used as drug delivery target in the development of anti-inflammatory drugs (e.g. Dekavil)...The disease process in OA shares features with the chronic wound healing response. Our findings support utilizing ED-A fibronectin for drug delivery or therapeutic targeting to reduce pro-inflammatory responses in OA."

Journal • IL6

Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis (clinicaltrials.gov) - P1b; N=5; Suspended; Sponsor: Pfizer; Trial completion date: Dec 2020 ➔ Mar 2021; Trial primary completion date: Dec 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date

F8-IL10: a new potential anti-rheumatic drug evaluated by a PET-guided translational approach. (PubMed, Mol Pharm) - "Patient observations and subsequently arthritic animal studies pointed to awareness of increased [124I]I-F8-IL10 uptake in liver and spleen associated with moderate systemic inflammation. This translational study demonstrated the value of in vivo biodistribution and PET-CT guided imaging in development of new and potential anti-rheumatic drugs'."

Journal

Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. (clinicaltrials.gov) - P2a; N=76; Recruiting; Sponsor: Pfizer; Trial completion date: Feb 2020 ➔ Jul 2021; Trial primary completion date: Feb 2020 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date

Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis (clinicaltrials.gov) - P1b; N=5; Suspended; Sponsor: Pfizer; Trial completion date: May 2020 ➔ Oct 2020; Initiation date: Mar 2019 ➔ Sep 2019; Trial primary completion date: May 2020 ➔ Oct 2020

Clinical • Trial completion date • Trial initiation date • Trial primary completion date