Biotech Values

[Mufaso]

ZEAL.CO - perfoming well on interim data today on their amylin analog in a small phase 1b trial (N=20 for part one of the study)

"Zealand Pharma announces positive topline results from the Phase 1b 16-week multiple ascending dose clinical trial with long-acting amylin analog petrelintide"
https://finance.yahoo.com/news/zealand-pharma-announces-positive-topline-153700688.html

-Body weight reductions of up to a mean of 8.6% with high dose petrelintide after 16 weekly doses (1.7% with placebo)
-Petrelintide was judged to be safe and well tolerated at all dose levels
-Results provide robust support of the potential of petrelintide as an effective alternative to GLP-1RA-based therapies for weight management
-Zealand Pharma anticipates initiation of a Phase 2b clinical trial in H2 2024

Petrelintide was assessed to be well tolerated in the trial, with no serious or severe adverse events (AEs). All gastrointestinal (GI) AEs were mild except for two moderate events (nausea and vomiting) reported by one participant who discontinued treatment after the third dose. Notably, no other participants discontinued treatment due to AEs. No other participants reported vomiting and there were only two reports of diarrhea, both of which were mild. Nausea was reported by 16.7-33.3% for active groups and 16.7% for placebo. A low number of participants reported injection site reactions, all of which were mild. No anti-drug antibodies were observed.

These topline results are from an interim data cut. The final results will be based on all collected data including complete post-treatment follow-up from the third cohort. Zealand expects to present more details on the 16-week results from Part 2 of the MAD trial at a scientific conference later this year. The company also plans to rapidly progress the clinical development of petrelintide and initiate a Phase 2b clinical trial later in 2024.

The part 2 of the trial involves dose escalation. I would expect the both the weight loss percentage and AE's to increase along with the dose escalation.