European Pharmaceuticals & Biotechnology "Feedback from ADA: take 2" Weston

研报英文原文证据摘录

European Pharmaceuticals & Biotechnology "Feedback from ADA: take 2" Weston

rat Hossain

data and that AZN intends to use the learnings to inform the P3 dose escalation Associate Analyst

schedule to enhance the tolerability profile in P3. We note there are a few cases of nusrat.hossain@ubs.com

liver enzyme elevation but all appear manageable at this stage. This is worth +44-20-7883 1586

monitoring, in our view, but not a major concern, and we note LLY's orfoglipron

also has a few cases of liver enzyme elevation in its P3 obesity trial. We note that

management classed the 2 bilirubin elevations as asymptomatic and not clinically

relevant. Managment views the clinical profile of elecoglipron as similar to

Foundayo, but with differentiation coming from the scope of the P3 program

(both in terms of combinations and indications) and AZN's commercial strength in

exUS markets (particularly in EM).

The SOLSTICE diabetes trial data also look encouraging with broadly consistent

tolerability profile compared to the obesity trial, especially considering difference

in dose escalation schemes versus the obesity trial.

Roche: Roche hosted an ADA investor call yesterday. Key takeaways include: 1) on

enicepatide P2 tolerability profile, where mid dose of 12mg (n=77) had 14%

treatment discontinuation due to adverse events (AEs), versus 5% / 7% on higher doses

at 16mg and 24mg, Roche and the trial investigator KOL believes these are likely due to

the nature of small P2 trials and said there was no specific AEs that contributed to this

higher discontinuation rate at mid dose. Indeed, Roche may go for higher than the

24mg dose in P3 as a way of differentiation. 2) On differentiation of enicepatide,

Roche believes it can potentially differentiate versus tirzepatide on glycemic control, and