Company: GRCE
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001140361-25-030398
Chunk: 24

Company: Grace Therapeutics, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Item 8
Chunk 24
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)(2) regulatory pathway
for GTx-104. 

Final results from this PK trial were
reported in May 2022, and showed that the bioavailability of GTx-104 compared
favorably with the oral formulation of nimodipine in all subjects, and no
serious adverse events were observed for GTx-104.

  25
  

In this trial, all endpoints indicated
that statistically there was no difference in exposures between GTx-104 and
oral nimodipine over the defined time periods for both maximum exposure and
total exposure. Plasma concentrations obtained following IV administration
showed significantly less variability between subjects as compared to oral
administration of capsules because IV administration is not as sensitive to
some of the physiological processes that affect oral administration, such as
taking the drug with and without meals, variable gastrointestinal transit time,
variable drug uptake from the gastrointestinal tract into the systemic
circulation, and variable hepatic blood flow and hepatic first pass metabolism.
Previous studies have shown these processes significantly affect the oral
bioavailability of nimodipine, and therefore cause oral administration to be
prone to larger inter- and intra-subject variability.

   The bioavailability of oral nimodipine capsules observed was only approximately 7% compared to 100% for GTx-104. Consequently, about one-twelfth the amount of nimodipine is delivered with GTx-104 to achieve comparable PKs as with the oral capsules. This data is presented in the chart below. 

   Regulatory

In April 2025, we announced details of
a Type C written meeting response with the FDA. The purpose of this meeting was
to obtain feedback on the completed Phase 3 STRIVE-ON safety trial of GTx-104
and our NDA submission, including clinical, non-clinical, and CMC requirements.

  26
  

   Feedback from the FDA informed our data and regulatory packages, and we submitted the NDA for GTx-104 on June 25, 2025. Acceptance of the NDA will be subject to the FDA’s review of the complete filing. 

   GTx-102 Overview

   GTx-102 is a novel, concentrated oral-mucosal spray of betamethasone intended to improve neurological symptoms of A-T for which there are currently no FDA-approved therapies. GTx-102 is a stable, concentrated oral spray formulation comprised of the gluco-corticosteroid betamethasone that,