Grace Therapeutics, Inc. (GRCE) announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the firm's New Drug Application (NDA) for GTx-104 for the treatment of patients with aneurysmal Subarachnoid Haemorrhage or aSAH.
GTx-104 is a clinical-stage injectable formulation of Nimodipine being developed for IV infusion in aSAH.
The FDA has referenced certain items in the chemistry, manufacturing, and controls (CMC) and non-clinical sections of the application, and Grace believes it can address them in a resubmission of its NDA.
The CRL cited items also include related leachable data for product packaging, non-clinical product toxicology risk assessments, and product manufacturing deficiencies at our contract manufacturing organisation.
Grace Therapeutics intends to resubmit the application following the resolution of the cited items.
The NDA application submitted earlier included data from the Phase 3 STRIVE-ON trial, a prospective, randomised, open-label trial of GTx-104 compared with oral Nimodipine in patients hospitalised with aSAH, which demonstrated clinical benefit compared with oral nimodipine.
The trial met its primary endpoint, with patients receiving GTx-104 observed to have a 19% reduction in at least one incidence of clinically significant hypotension compared to oral Nimodipine (28% versus 35%).
In addition, there were fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral Nimodipine.
Meanwhile, there were eight deaths on the GTx-104 arm compared to four deaths on the oral Nimodipine arm. According to the firm, the deaths in both arms were due to the severity of the patient's underlying disease, and no deaths were determined to be related to GTx-104 or oral nimodipine.
Also, with respect to the CRL, the company intends to request a Type A meeting with the FDA to clarify the path forward and determine the appropriate next steps.
GRCE has traded between $1.79 and $5.18 over the last year. The stock closed Thursday's trade at $2.35, down 45.48%.
In the overnight market, GRCE is down 3.40% at $2.27.
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