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Obesity drug developer, Gila Therapeutics, recently took a big step toward FDA approval for its new weight control treatment, completing its Phase I clinical trial in August. Gila is developing a novel intra-oral delivery of PYY, a well-known satiety hormone, to help patients reduce caloric intake and lose weight. Previous attempts to use PYY for this purpose have run into issues associated with systemic side effects of nausea and vomiting.

“We are thrilled to announce these results of our Phase I trial,” said co-founder and CEO, Dr. Thomas Vasicek. “We met our primary safety endpoint; the subjects reported no taste difference from placebo and experienced no nausea. We also assessed food consumption and satiety as secondary endpoints. While there was no significant effect on food consumption, there was a clear dose response effect on satiety.”

The next step for the company, according to Dr. Vasicek, is developing a clinical plan to demonstrate proof of concept for its intra-oral PYY approach, including a Phase II randomized, blinded, and placebo controlled study specifically designed to assess food intake and refine the optimal dose to carry forward into future trials.

This plan and the budget will serve as the basis of a Series B raise.

Gila Therapeutics is developing a novel treatment for obesity involving topical, lingual application of satiety hormones that naturally make users feel full after they eat. These hormones are normally secreted by the intestines after food begins leaving the stomach, but by providing them before eating, Gila’s solution can help users feel full sooner, eat less and lose weight. It began the Investigational New Drug (IND) process with the U.S. Food & Drug Administration (FDA) on July 5 and, in less than five weeks, the company enrolled and tested all 12 healthy volunteers, dosing the last subject on August 10.

Primary Endpoints: Safety and Tolerability

  • No issues
  • No systemic absorption

Secondary Endpoints: Food Intake and Satiety

  • No significant change in food intake
  • Significant increase in satiety. Subjects reported a persistent feeling of fullness, significantly greater than placebo.

Since the completion of the Phase I trial, the company has submitted an NIH SBIR grant application and two DoD pre-applications for non-dilutive funding based on the formulation and pre-clinical work that it has done.

To date, Gila Therapeutics has accomplished the following milestones:

  • Negotiated an exclusive IP license with the University of Florida
  • Raised Series A financing
  • Developed the clinical formulation, which has been stable for 6+ months
  • Completed pre-clinical work with no tolerability issues
  • Established a regulatory and clinical plan
  • Filed for Investigational New Drug in June 2017
  • Successfully completed Phase I safety study in August 2017

This is great news for Gila. Visit MyiSelect to learn more.