Breaking News and Views - Lupus, Gout and Spondyloarthropathy
Pharma Information and Reports is pleased to announce availability of December's issues of the following UpdatesPlus reports:
Sifalimumab (IFNα): Phase 2b Sifalimumab data were presented at ACR 2014. Patients with severe disease at baseline responded to q4w sifalimumab with an increase in SRI-4 rates (45% to 57-60%). CLASI measures of skin involvement as well as joint disease and fatigue were also improved. Increased incidence of zoster is, for the moment the AE of greatest concern (8.4% at the highest dose tested vs 0.9% with placebo)
Comments: SRI rates are still rather modest, albeit higher than those historically reported for Benlysta. Moreover sifalimumab efficacy was quite flat over a broad dose range (200, 600, 1200mg iv). This suggests redundancy in inflammatory pathways responsible for lupus, or alternatively sub-populations of patients. AstraZeneca is developing anifrolumab as well as sifalimumab. Anifrolumab blocks the type 1 IFN receptor and hence a broader spectrum of interferons (IFNα, IFNβ, and IFNω). If there is redundancy amongst the interferons Anifrolumab may offer greater efficacy. We suspect AstraZeneca will wait for Phase 2 anifrolumab data expected in 2015 before selecting a Phase 3 candidate.
To access our full 37 slide report please contact: fiona.watts@leaddiscovery.co.uk
Lesinurad/RDEA3170: AstraZeneca reported further data from CLEAR1 and CLEAR2 at ACR2014. Data were initially reported in Aug 2014 . New data demonstrated stable efficacy of a Lesinurad/allopurinol combo over 12mo
In addition to lesinurad, AstraZeneca is developing a 2nd generation URAT1 inhibitor, RDEA3170. A Phase 2 monotherapy study is now complete. A Phase 2 febuxostat combination study has also recently been announced and the first patients have now been recruited
Comments: AstraZeneca had previously indicated that EU and US filings for lesinurad would be submitted in Q4 2014. At the time of writing it appears that this will more likely be Q1 2015. Reasons for this are unclear
To access our full 21 slide report please contact: fiona.watts@leaddiscovery.co.uk
- UpdatesPlus-Lupus
- UpdatesPlus-Gout
- UpdatesPlus-Spondyloarthropathy (Psoriatic Arthritis, Ankylosis Spondylitis and Axial Spondyloarthropathy)
UpdatesPlus offers A unique and affordable combination of information monitoring and expert analysis across 14 therapy areas [further information]
Top news from lupus
Sifalimumab (IFNα): Phase 2b Sifalimumab data were presented at ACR 2014. Patients with severe disease at baseline responded to q4w sifalimumab with an increase in SRI-4 rates (45% to 57-60%). CLASI measures of skin involvement as well as joint disease and fatigue were also improved. Increased incidence of zoster is, for the moment the AE of greatest concern (8.4% at the highest dose tested vs 0.9% with placebo)
Comments: SRI rates are still rather modest, albeit higher than those historically reported for Benlysta. Moreover sifalimumab efficacy was quite flat over a broad dose range (200, 600, 1200mg iv). This suggests redundancy in inflammatory pathways responsible for lupus, or alternatively sub-populations of patients. AstraZeneca is developing anifrolumab as well as sifalimumab. Anifrolumab blocks the type 1 IFN receptor and hence a broader spectrum of interferons (IFNα, IFNβ, and IFNω). If there is redundancy amongst the interferons Anifrolumab may offer greater efficacy. We suspect AstraZeneca will wait for Phase 2 anifrolumab data expected in 2015 before selecting a Phase 3 candidate.
To access our full 37 slide report please contact: fiona.watts@leaddiscovery.co.uk
Top news from gout
In addition to lesinurad, AstraZeneca is developing a 2nd generation URAT1 inhibitor, RDEA3170. A Phase 2 monotherapy study is now complete. A Phase 2 febuxostat combination study has also recently been announced and the first patients have now been recruited
Comments: AstraZeneca had previously indicated that EU and US filings for lesinurad would be submitted in Q4 2014. At the time of writing it appears that this will more likely be Q1 2015. Reasons for this are unclear
To access our full 21 slide report please contact: fiona.watts@leaddiscovery.co.uk
posted by Jon Goldhill at 11:23 AM
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