AMG 108 / AstraZeneca - LARVOL DELTA

SAR445399 – an anti-IL-1R3 monoclonal antibody that blocks IL-1, IL-33 and IL-36 cytokine pathways for dermatologic diseases (ISDS 2023) - "Multiple therapies targeting individual members of the IL-1 family have only shown low to moderate efficacy in dermatologic disorders such as: αIL-36γ (Spesolimab) in AD, HS and PPP, αIL-33 (Itepekimab) in AD and IL-1R antagonist (Anakinra) or αIL-1R (MEDI-8968) in HS. Furthermore, an anti-murine surrogate of SAR445399 alleviates disease and inflammation in an Imiquimod-induced skin inflammation model with superior efficacy than IL-1 blockade alone. In summary, SAR445399 is a broad IL-1 pathway drug hitting 3 birds with 1 stone and is uniquely positioned to potentially raising the efficacy ceiling where a single agent therapy may not be fully efficacious in dermatology or other immunology areas."

Atopic Dermatitis • Dermatitis • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation • Psoriasis • IL1B • IL1RAP • IL33

The Current Role of Disease-modifying Osteoarthritis Drugs. (PubMed, Arch Bone Jt Surg) - "It was encountered that many publications have analyzed the impact of several DMOAD methods, including anti-cytokine therapy (tanezumab, AMG 108, adalimumab, etanercept, anakinra), enzyme inhibitors (M6495, doxycycline, cindunistat, PG-116800), growth factors (bone morphogenetic protein-7, sprifermin), gene therapy (micro ribonucleic acids, antisense oligonucleotides), peptides (calcitonin) and others (SM04690, senolitic, transient receptor potential vanilloid 4, neural EGFL-like 1, TPCA-1, tofacitinib, lorecivivint and quercitrin). In conclusion, even though DMOADs seem promising, their clinical effectiveness has not yet been demonstrated for managing OA. Until forthcoming studies can proved the medications' capacity to repair and regenerate tissues affected by OA, physicians should keep using treatments that only intend to alleviate pain."

Journal • Review • Gene Therapies • Immunology • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology • NELL1

[Poster Board # 601] A phase 2 study of MEDI8968, an anti-interleukin-1 receptor I (IL-1RI) monoclonal antibody, in adults with moderate-to-very severe chronic obstructive pulmonary disease (COPD), [Publication Number: A3964] (ATS 2015) - Presentation time: Tuesday, May 19, 2015, 9:30 AM - 11:30 AM; P2, N=324; SPRING (NCT01448850); Sponsor: MedImmune LLC; "There were no significant differences between placebo and MEDI8968 300 mg SC (600 mg IV loading dose) administered Q4W for 52 weeks on AECOPD rate, SGRQ-C score, and FEV1. The safety and tolerability profile of MEDI8968 was similar to that of placebo."

P2 data • Chronic Obstructive Pulmonary Disease • Immunology

A Randomized Double Blind, Placebo Controlled Trial With AMG 108 in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Amgen; N=200 ➔ 0

Enrollment change • Biosimilar • Diabetes

Systematic review of immunomodulatory therapies for hidradenitis suppurativa. (PubMed, Biologics) - "...Published data from clinical trials support the efficacy of adalimumab, infliximab, anakinra, ustekinumab, bermekimab and apremilast but not etanercept and MEDI8968. Clinical trials for CJM112 have been completed, with results awaiting publication. Trials are underway for secukinumab, IFX-1, INCB054707 and bimekizumab. Biologics used in smaller cohorts include canakinumab, golimumab and rituximab...Different clinical measurement scores and endpoints used to make direct comparison difficult. Longitudinal surveillance and pooled registry data are paramount to evaluate the long-term safety profile and efficacy of therapy."

Journal • Review