Company: GRCE
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001140361-25-030398
Chunk: 21

Company: Grace Therapeutics, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Item 8
Chunk 21
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1988 and is the only approved drug that has been clinically shown to improve neurological outcomes in aSAH patients. It is only available in the United States as a generic oral capsule and as a branded oral liquid solution called NYMALIZE™, which is manufactured and sold by Arbor Pharmaceuticals (acquired in September 2021 by Azurity Pharmaceuticals). Nimodipine has poor water solubility and high permeability characteristics because of its high lipophilicity. Additionally, orally administered nimodipine has dose-limiting side-effects such as hypotension, poor absorption and low bioavailability resulting from high first-pass metabolism, and a narrow administration window as food effects lower bioavailability significantly. Due to these issues, blood levels of orally administered nimodipine can be highly variable, making it difficult to manage blood pressure in aSAH patients, often leading to frequent dose interruptions. Nimodipine capsules are also difficult to administer, particularly to unconscious patients or those with impaired ability to swallow, while the oral liquid solution has tolerability challenges due to solubility limitations of nimodipine.

   GTx-104 Technology

Our lead drug candidate, GTx-104, is a
novel injectable formulation of nimodipine for the treatment of aSAH. This
formulation offers several potential advantages over oral administration of
nimodipine that is the current Standard of Care (SoC) in the United States. 

     •

     Novel injectable formulation of nimodipine

     •

     Overcomes solubility limitations of nimodipine

     •

     A patented formulation that uses non-ionic surfactant micelles as the drug carrier to solubilize nimodipine

     •

     Simple to prepare in a pharmacy and stable at room temperature

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   Value Proposition

   GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.