Part 2 Update Dispels Malignancy Concerns; Remain Overweight

研报英文原文证据摘录

Part 2 Update Dispels Malignancy Concerns; Remain Overweight

EAIR of 0.35 per 100 PY (patient years), which is at the associated with marketed and pipeline products.

low end of the reference range (0.30-0.70), and dispelling arguments of an obefazimod-

related malignancy signal. To be clear, this includes two new non-NMSC malignancies at Price Performance - 1 Year

50mg and zero at 25mg. And while a significant share of our investor discussions since USD

the Part 1 topline had centered around potential market reaction to optics that Part 2 had 160

a non-NMSC malignancy imbalance, the data disclosure was well contextualized this 140

time around in terms of patient exposure (i.e., 68.6% of Part 2 patient year exposure at 120

50mg and 31.4% at 25mg) and case-level details clearly indicated the new malignancies 100

(one myeloproliferative neoplasm and one prostate cancer) were not drug related. On 80

NMSC (non-melanoma skin cancer), Part 2 included two cases each at the 25mg and 40

50mg doses, but the integrated UC EAIR of 0.59 per 100 PY was below the reference 20

range of 0.7-1.40. 0

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• Efficacy profile strengthened by Part 2. What’s been lost in the last four weeks Source: Bloomberg

of focus over what now looks to be an illusory malignancy signal is obefazimod’s

remarkable efficacy profile, which recall included a 40% pbo-adjusted clinical remission

rate at 44wks for 50mg, surpassing even Rinvoq. Building on Part 1, we view the

50mg induction nonresponder data from Part 2 as the most incremental efficacy update.

Specifically, patients who failed to respond to 8 weeks of induction treatment but

continued on 50mg maintenance (n=148) achieved a 37.2% clinical remission and