Regulatory Update
Sanofi announced that in a 52-week, 36 patient, Phase II/III trial, treatment with olipudase resulted in a relative improvement of 22% in the predicted diffusing capacity of carbon monoxide (DLco) and a 39.5% decrease in spleen size compared to a 3% DLco improvement and a 0.5% decrease in spleen size with placebo in adult patients with acid sphingomyelinase deficiency (Niemann-Pick Disease). However, treatment with olipudase did not improve the Splenomegaly Related Score compared to placebo. Sanofi announced that in a 52-week, 20 patient, open-label, Phase II trial, treatment with olipudase resulted in a relative DLco improvement of 33% and a 49% decrease in spleen size in patients < 18 years old with acid sphingomyelinase deficiency. The NIH announced that it halted a trial after interim data from 5,383 patients enrolled in a 5,407 HIV-negative patient, Phase IIb/III trial, showed that 129/2,694 patients who received the Sanofi Pasteur vaccine with the GSK immunity-boosting adjuvant became infected with HIV compared to 123/2,689 patients that received placebo. Published Research Updates In a 12-week, 111 patient, Phase IIb trial, several dosing regimens of tirzepatide lowered HbA1c more than placebo in patients with type 2 diabetes. In a 13-week, 42 patient, Phase II, open-label trial, treatment with bermekimab resulted in 61% of patients naive to anti-TNF treatment and 63% of patients that failed anti-TNF treatment achieving Hidradenitis Suppurativa Clinical Response (HiSCR), which was defined as a greater than or equal to 50% reduction in inflammatory lesion count and no increase in abscesses or draining fistulas. In an 8-week, 204 patient, Phase II trial, 33.3% of patients treated with serlopitant achieved a 4 point or > worst-itch numeric rating scale (WI-NRS) score compared to 21.1% with placebo in patients with pruritus associated with psoriasis. Comments are closed.
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