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Glucagon Patch Meets Phase 2 Goal

ZP-Glucagon Patch may help prevent severe outcomes with hypoglycemia.

Zosano Pharma has announced positive results from phase 2 clinical trials of its glucagon patch, called ZP-Glucagon. It is indicated for the treatment of severe hypoglycemia.

Glucagon is a hormone produced by pancreatic alpha cells that is released during times of low blood glucose to increase blood glucose levels. It works by stimulating the liver to convert glycogen to glucose and release the converted product into circulation. It currently sees clinical use as an injectable rescue medication for severe hypoglycemia.

Zosano’s product is a rapid onset, transdermal microneedle glucagon patch. The phase 2 trials were conducted to evaluate safety and efficacy of the patch versus standard of care (injectable glucagon) for the treatment of insulin-induced severe hypoglycemia. The study design was an open-label, randomized four-way crossover trial with 16 total subjects. The study compared two doses of the ZP-Glucagon patch (0.5 mg and 1 mg) with two doses of intramuscular glucagon injections (0.5 mg and 1 mg as well).

The results of the study showed that 100 percent of subjects achieved normalized blood sugar with both strengths of the patch. Both the 0.5 mg and 1 mg strength of the patch had sufficiently rapid onset of action. The patch and the glucagon injection both had similar response times as well. The trial did not identify any new safety issues with use of the patch versus intramuscular glucagon.

A patch formulation of glucagon offers an ease-of-use advantage to the standard-of-care intramuscular injection. In an emergency, patients and caregivers may find it easier to apply a patch and press down versus using an injection. The injection requires more dexterity to actually draw up a dose and deliver an injection. This can result in needle stick injuries or delayed treatment.

The study has not been published yet. Zosano reports that the ZP-Glucagon patch has been tested in over 400 patients throughout phase 1 and phase 2 trials.

Practice Pearls:

  • Both doses of the ZP-glucagon patch had similar time to onset and efficacy with standard-of-care in this phase 2 trial.
  • The patch offers ease-of-use and safety advantages over the standard-of-care glucagon intramuscular injection.
  • No new safety issues or adverse effects were associated with the ZP-glucagon patch.

“Zosano Pharma Announces Positive Phase 2 Results for Its ZP-Glucagon Patch Program for Treatment of Severe Hypoglycemia.” Fremont, CA. October 13, 2015. Available at: http://ir.zosanopharma.com/releasedetail.cfm?ReleaseID=936338.