XERS

Pramlintide-Insulin

Type 1 & 2 Diabetes

Stage (next event)

Expected Date

Phase 2 (FDA Meeting)

H1 2021

Catalyst Info & Data Links

TITLE: Pramlintide-Insulin for Type 1 & 2 Diabetes - Phase 2 FDA Meeting

  • ClinicalTrials.gov (NCT04074317): Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D


WHAT IS THE CATALYST EVENT?


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • H1 2021


PRIOR DATA/EVENTS

PRESS RELEASE


Mechanism of Action

MECHANISM OF ACTION

  • Pramlintide is an analog of amylin, a natural hormone that inhibits glucagon secretion, delays gastric emptying, and is known to help increase satiety. Pramlintide is indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy. It works by slowing the movement of food through the stomach. This prevents blood sugar from rising too high after a meal and may decrease appetite and cause weight loss. Pramlintide use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes.

MARKET

  • There are 22.1M persons with diabetes in the US (T1D & T2D), where 6.2M currently use insulin

Updated by HC

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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