Zealand’s amylin is promising, but way behind Novo’s combo

The amylin analogue ZP8396 is safe, though does not produce immense weight loss, when administered repeatedly at low doses for six weeks, Zealand Pharma said today. This is promising data, because at this point in the project’s development the safety matters more than the effectiveness. The new results come from part 1 of a phase 1 multiple ascending dose trial in healthy lean and overweight people, and the clean safety – there were no serious or severe adverse events and no withdrawals – means the company can go ahead with the second part of the trial. This will test “significantly higher doses”, necessitating titration, over the course of four months, and will yield top-line data next year. The group intends ZP8396 as both an add-on to incretin-based obesity therapy and as an alternative to incretins, which can be hard to tolerate as Zealand itself knows all too well. As for the combination strategy, Novo Nordisk is already ahead. Novo’s Cagrisema project – a combination of the amylin analogue cagrilintide and the GLP-1 semaglutide – achieved weight loss of up to 15.6% in a phase 2 trial in overweight and obese patients with diabetes. Cagrisema is currently in four phase 3 trials.

Phase 1 data so far on Zealand's ZP8396
Trial Ph1 single dose trial Part 1 of Ph1 multiple ascending dose trial
Dose   0.7mg     1.4mg     2.4mg   0.6mg once weekly  1.2mg once weekly
Pbo-adj weight loss -3.2% -4.2% -4.8% -4.9% -4.7%
All data at 6wk. Source: company releases.

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