Friday, February 6, 2015

Biotech Investing: Will Anthera (ANTH) ever report interim analysis of Blisibimod

Anthera Pharma (ANTH) stated in their 3rd quarter press release (see below) that they planned delay the interim analysis of their lead compound Blisibimod in both the Phase 3 Lupus trial and the Phase 2/3 IgA trail due to partnership discussions which were expected to be concluded in 2014.  Well, the partnership with Zenyaku Kogyo Co. was announced on December 15th so we are coming up to two months after the deal and still no interim analysis results???  Have they been completed and not announced???

Also, who the heck is Zenyaku Kogyo Co?  I pulled up their website and translated it into English and it looks like a mix between a Japamation studio and OTC medicine shop (link below).  My favorite drug that's highlighted on their front page in DICKININ which includes ingredients ibuprofen, caffeine, and licorice extract.  Let's hope the Anthera shareholders don't get DICKININ with their investment!

As always, good luck fellow biotech investors and have a great weekend!

https://translate.google.com/translate?hl=en&sl=ja&tl=en&u=http%3A%2F%2Fwww.zenyaku.co.jp%2F



Blisibimod

Our Phase 3 systemic lupus erythematosus clinical study, CHABLIS-SC1, is recruiting patients in Eastern EuropeLatin America and Southeast Asia.  To date, we have enrolled over 260 of the 400 patients planned for the CHABLIS-SC1 study.  Enrolled patient demographics and disease characteristics for the CHABLIS-SC1 study continued to be consistent with our goal to enroll patients with higher levels of lupus activity and positive biomarkers despite the stable use of corticosteroids.  These characteristics appeared predictive of improved outcomes in our previous Phase 2 clinical study.  

Our Phase 2/3 IgA nephropathy study, BRIGHT-SC, is currently recruiting patients with a biopsy-proven diagnosis of IgA nephropathy primarily in Southeast Asia. Our expansion of BRIGHT-SC study's footprint in Europe and Canada is underway with sites in the European Union likely to be initiated in the fourth quarter of 2014.  The baseline characteristics of patients enrolled in the BRIGHT-SC study continued to be consistent with our objectives to enroll patients with a biopsy diagnosis of IgA nephropathy, high levels of proteinuria, and kidney function indicative of progressive kidney disease.

Interim analyses of CHABLIS-SC1 and BRIGHT-SC were planned for the third quarter of 2014 to confirm the clinical assumptions of the designs of these two studies.  However, due to our on-going partnership negotiations for Asian rights for blisibimod for both lupus and IgA nephropathy, we elected to delay these analyses.  We expect these discussions will be completed during the fourth quarter of 2014. There can be no assurance that a definitive agreement will be executed relating to any proposed partnership, or that any partnership will be approved or consummated.

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