Interleukin 1 Market: Competitive Landscape, Pipeline, and Market Analysis 2023

IL-1, also known as interleukin-1, is a cytokine that plays a crucial role in the immune response and inflammation. It is produced by various cells, including macrophages, monocytes, and dendritic cells. The mechanism of action of IL-1 involves binding to specific receptors on target cells, triggering a cascade of signaling events that lead to the activation of immune cells and the production of various pro-inflammatory molecules. IL-1 is implicated in the pathogenesis of several diseases, including rheumatoid arthritis, systemic juvenile idiopathic arthritis, adult-onset Still's disease, and other autoimmune and inflammatory conditions. IL-1 inhibitors are used in these indications to suppress the excessive inflammatory response and alleviate symptoms. According to the World Health Organization (WHO), rheumatoid arthritis affects approximately 1% of the population in Europe and the USA, with an estimated 1.3 million adults affected in the United States alone and the economic burden of rheumatoid arthritis is substantial, costs around €45 billion annually in Europe.

The growth drivers of the IL-1 market include increasing research and development efforts to develop novel IL-1 inhibitors, expanding applications of IL-1 inhibitors in various disease indications, and growing demand for targeted immunomodulatory therapies. Additionally, the rising prevalence of autoimmune and inflammatory diseases, along with the aging population, further contributes to the market's growth potential. Companies such as Novartis, J&J, Olatec Therapy, Amgen, Roche, AstraZeneca, Merck (MSD), Melinta Therap, Buzzard Pharma, Hutchmed, XBiotech, Ferring, AbbVie cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, AstraZeneca is one such company that is currently conducting a clinical trial of the drug AMG108 for the treatment of idiopathic pulmonary fibrosis.

Key Developments

• In Nov 2022, Amgen’s Anakinra registered (emergency use authorization) for COVID-19 pneumonia in USA
• In May 2023, MediciNova received notice of intention to grant patent for Ibudilast in microorganism infection in Europe .
• In March 2023, MediciNova extended the contract with BARDA to repurpose ibudilast against chlorine-gas-induced lung damage such as acute respiratory distress syndrome and acute lung injury

Approved IL-1 molecules

• Lenalidomide
• Pomalidomide
• Minocycline
• Kineret (anakinra)
• Ilaris (canakinumab)
• Diacerein
• Minocycline extended release
• Eyevinal (ibudilast)
• Arcalyst (rilonacept)
• Hutruo (bermekimab IV)
• Saccovid (efprezimod alfa)
• Minocin for injection (minocycline intravenous)
• Natrunix (vilamakitug)

IL-1 Pipeline Molecules

• Gevokizumab (VPM087)
• Bermekimab sc (MABp1 sc)
• Amzeeq (minocycline topical foam 4%)
• Goflikicept (RPH-104)
• Dapansutrile (OLT1177)
• Astegolimab (RG 6149)
• AMG 108
• Isunakinra (EBI-005)
• HMPL-004
• Zilxi (minocycline topical foam 1.5%)
• Minocycline modified release (DFD-29)
• Semapimod (AXD-455)
• Tadekinig alfa (IL-18BP)
• RLS-0071
• Diacerein controlled release (AC 201)
• Lutikizumab (ABT 981)
• Melrilimab (GSK3772847)
• CU06
• DRM02
• FL-101
• TT-301
• Dapansutrile topical (OLT1177 gel)
• 9MW1911
• AD-35
• DTRM-555
• GNSC-001
• HL2351
• LY 2189102

Clinical Activity and Development of IL-1

In the IL-1 space, more than 20 companies are conducting more than 1,000 clinical trials in this category of drugs. For instance,

• In Feb 2023, MediciNova presented the updated efficacy data from the phase IIb sprint-ms trial of Ibudilast in progressive multiple sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2023 (ACTRIMS-2023)
• In March 2023, Kiniska Pharmaceutical and Regeneron Pharmaceutical presented long-term extension adverse events data from the phase III rhapsody trial of Rilonacept in Pericarditis at the American Heart Association Scientific Sessions (AHA-2022)