Replies to post #161042 on Biotech Values

[DewDiligence]

Re: XOMA competition in uveitis

Humira - highly likely to be significantly active. That said, the endpoints are complex and I haven't worked through them. Scheduled to complete in the latter half of 2014.

Note that ABBV is testing Humira in two phase-3 uveitis studies that roughly parallel XOMA’s EYEGUARD-A and EYEGUARD-C in active and stable disease, respectively. The primary endpoint in ABBV’s trials is indeed complex, but in both cases vitreous haze is a component of the endpoint (on an absolute basis in the active-disease trial and a relative basis in the stable-disease trial).

Sirolimus intravitreal injections. No idea of possible chance of success. Scheduled to complete trials in late 2014.

In Santen’s phase-3 everolimus trial, the primary endpoint is identical to XOMA’s (proportion of patients with a 2-step reduction in vitreous haze), although this isn’t clear from the description at clinicaltrials.gov.

[DonShimoda]

Thanks for the heads up. I'll update the XOMA RMF to reflect same.

[DewDiligence]

Early competition of a sort in posterior uveitis from PSDV:

http://finance.yahoo.com/news/psivida-corp-announces-interim-data-120000291.html

[DewDiligence]

OPLI* is another (early) XOMA competitor in NIU:

http://finance.yahoo.com/news/ophthalix-initiate-phase-ii-study-214400692.html

*An 83%-owned subsidiary of Israel’s Can-Fite BioPharma.

[DewDiligence]

(XOMA)—Santen reports positive phase-3 Sirolimus data in NIU:

http://finance.yahoo.com/news/santen-phase-iii-study-meets-130000465.html

Santen Pharmaceutical Co., Ltd. (Osaka, Japan), today announced that SAKURA (Study Assessing double-masKed Uveitis tReAtment) Study 1, the first of two Global Phase III studies evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU), met its primary endpoint.

…347 patients with non-infectious posterior, intermediate or panuveitis were enrolled at approximately 150 sites for SAKURA Study 1. Eligible patients were randomized into three treatment arms, each receiving different doses of sirolimus by intravitreal injection. The primary endpoint was the proportion of patients achieving a vitreous haze score of zero at month five (Standardized Uveitis Nomenclature [SUN] Photographic scale). SAKURA Study 2 continues to enroll patients under the same protocol.

Santen may be waiting for the results of SAKURA-2 so it can present both studies at a medical conference simultaneously.

It’s notable that the primary endpoint in both of these trials is based on the absolute vitreous haze score rather than the delta from baseline.