IRAK4 RA Flashcards
Question
Answer
Competitor advantages / Disadvantages
Pfizer Asset advantages / disadvantages
Disadvantage: >24 months behind large number of compounds in Ph3 and Ph2 for RA. Advantages: None of late stage competitors have met efficacy criteria set forth for advancement of Pfizer asset, Pfizer currently leading in clinical development, with no other IRAK4 inhibitors in clinical development
Competitors (All MOA)
Ph3: Barcitinib (Incyte, JAK1/JAK2 inhibitor), IR-501 (Immune Response; vaccine), Masitinib (AB Science, c-kit inhibitor), ofatumumab (Genmab, CD20 inhibitor), Sarilumab (Regeneron, anti-IL-6R), Siukumab (Janssen, anti-IL6). Ph2: HU-003 (Huons, sepsis, targets IRAK 4), Ph2: Filgotinib (Galapagos, JAK1 inhibitor); Clazakizumab (Alder, anti-IL-6); Guselkumab (Janssen, anti-IL-23); Olokizumab (UCB, anti-IL-6); Peficitinib (Astellas, JAK1/JAK3 inhibitor); Ustekinumab (Janssen, anti-IL-12/IL-23); Spebrutinib (Avila, Btk inhibitor); ABT-494 (Abbott; JAK1 inhibitor); ACP-196 (Acerta, Btk inhibitor); ALX-0061 (Ablynx; anti-IL-6); CF-101 (NIH, anti-adenosine A3-R); PRT-2607 (Portola; Syk inhibitor); PRTX-1000 (Protalex, Staph Prot A); Xmab-5871 (XenCor, anti-CD19). Ph1: AMP-110 (Amplimmune, anti-B7H4); ARG-301 (Univ Tennessee, HLA class II antigen); Blisibimod (Amgen, anti-BAFF); PCI-45292 (Pharmacyclics, Btk inhibitor); Cerdulatinib (Portol, JAK/Syk inhibitor); CFZ-533 (Novartis, CD40-R); Decernotinib (Vertex, JAK3 inhibitor); GS-9876 (Gilead, Syk inhibitor); KD-025 (Surface Logix, anti-IL-17); TAK-020 (Takeda, Btk inhibitor). Preclinical IRAK 4 inhibitors: Rigel, Nimbus, Pharmacopeia, Albany, SignalChem, and Aurigene all in preclin for inflammatory disease, autoimmune disease, diffuse large B cell lymphoma, and/or cancer.
What phase of development is Pfizer Asset?
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When/what is next milestone for Pfizer Asset?
POC Ph2b
Indication Standard of Care
DMARD monotherapy or combination, or TNFi, or non-TNF biologic, low-dose glucocorticoids
Indication Prevalence
In 2013, the Centers for Disease Control and Prevention announced data estimating that 52.5 million U.S. adults suffer from arthritis - equating to about 23 percent of the population.
peak projected sales
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