Replies to post #94916 on Biotech Values

[mcbio]

On BCX-4208 safety
Quote:
--------------------------------------------------------------------------------
this PNP inhibitor’s ability to reduce uric acid levels in the blood
--------------------------------------------------------------------------------

But it also suppress the immune system (T and B cells). Similar to the gout trial, in the phase IIa trial in psoriasis BCX-4208 was generally safe and well-tolerated at doses up to 120 mg daily for 6 weeks. However, the suppressive effect on the immune system probably takes longer to manifest itself.

Just curious if you caught BCRX's recent Phase 2b data for their gout drug: http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=637691 .

On the safety front, the Phase 2b tested the gout drug out to 24 weeks at doses of 5mg, 10mg, 20mg, and 40mg QD with allopurinol. AEs, including infections, were similar in both the drug and placebo groups. They did discontinue the 40mg arm because that arm met the protocol-defined cohort stopping rule based on number of withdrawals for reduction in CD4+ cell counts. Also, four patients in the 20mg discontinued because of redution in CD4+ cell counts.

BCRX plans to continue with 5, 10, and 20 mg doses, though I don't think they plan to go into Phase 3 absent a partner. Efficacy in the 10mg group, where there were no patient dropouts related to CD4+ reductions, looked as good as the higher doses. Do you see concern that even the lower doses, such as 10mg, would see issues with drops in CD4+ counts as we go beyond 24 weeks or is 24 weeks a reasonable length of time to think this might be a reasonable dose for the drug going forward? Note, again, that even with reductions in CD4+ in the higher arms, the AEs, including infections, were similar across all dosing groups.