Company: GRCE
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001140361-25-041804
Chunk: 29

Company: Grace Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Item 8
Chunk 29
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 December 2022, we reported that the topline results of this trial met all primary outcome measures.

   Next Steps

The
further development of GTx-102 has been deprioritized in favor of our focus on
development of GTx-104. On February 13, 2025, we announced FDA’s written
responses to our GTx-102 End of Phase 1 meeting request where FDA made
recommendations on the path toward an NDA. They provided guidance on the design
of a single pivotal efficacy and safety trial, including the neurological
assessment scale for the primary endpoint, that could, with appropriate
confirmatory evidence, support an NDA. We plan to collaborate with our
scientific advisory board and FDA (via Type C meeting) on the design of a
potential pivotal efficacy and safety trial and will determine the next steps
after that time. Further clinical development work will be contingent on
additional funding for GTx-102 or the signing of a strategic partnership. It is
also possible that we may out-license or sell our GTx-102 drug candidate for
the U.S. and/or global markets. 

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   GTx-101 Overview

   GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to ease the symptoms of patients suffering with PHN. GTx-101 is administered via a metered-dose of bupivacaine spray and forms a thin bio-adhesive topical film on the surface of the patient’s skin, which enables a touch-free, non-greasy application. It also comes in convenient, portable 30 ml plastic bottles. Unlike oral gabapentin and lidocaine patches which are used for the treatment of PHN, we believe that the biphasic delivery mechanism of GTx-101 has the potential for rapid onset of action and continuous pain relief for up to eight hours. No skin sensitivity was reported in a Phase 1 trial.

   About Postherpetic Neuralgia (PHN)

   PHN is neuropathic pain due to damage caused by the varicella zoster virus (“VZV”). Infection with VZV causes two distinct clinical conditions. Primary VZV infection causes varicella (i.e., chickenpox), a contagious rash illness that typically occurs among young children. Secondary VZV can reactivate clinically, decades after initial infection, to cause herpes zoster (“HZ”), otherwise known as