Drugs

Grace Therapeutics Preparing NDA Resubmission

Grace Therapeutics says it plans to resubmit its NDA for GTx-104 after receiving an FDA Complete Response Letter in April, with a Type A meeting now scheduled to clarify the agency's expectations and outline a path forward for the intravenous nimodipine candidate.

The letter cited outstanding manufacturing and non-clinical issues rather than problems with clinical efficacy, according to the company. The drug is being developed for intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, a life-threatening form of stroke caused by bleeding into the space surrounding the brain.

The company says the agency action focused on deficiencies in chemistry, manufacturing and controls, as well as certain non-clinical data requirements. Importantly, the agency did not request any additional clinical trials, a signal that the drug’s efficacy and safety data in patients may be sufficient pending resolution of the technical concerns.

According to Grace, the agency requested additional leachables data from commercial product batches, further nonclinical toxicology risk assessments, and remediation of current GMP deficiencies associated with the company's contract manufacturing organization.

"We have been working diligently on addressing the cited items, and we look forward to a constructive discussion with the FDA as we continue to prepare our resubmission," Chief Executive Officer Prashant Kohli said in a statement.

The company said a Type A meeting with FDA has been scheduled and that it expects to provide a regulatory update after receiving official meeting minutes. Type A meetings are typically reserved for stalled development programs or disputes requiring immediate FDA input.

If approved, GTx-104 would offer an intravenous formulation of nimodipine, a drug that has remained the standard of care for aSAH patients for decades but is currently administered orally or through feeding tubes, according to the company.

As of March 31, Grace reported $17 million in cash and cash equivalents and said its current resources are expected to fund operations for at least the next 12 months, including activities required to address the issues identified in the CRL and support the planned NDA resubmission.

The outcome of the upcoming Type A meeting is expected to provide greater clarity on the timing and content of the resubmission and could determine how quickly the application returns to FDA review.

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