NeuroScientific completes FDA pre-IND meeting on EmtinB for advanced glaucoma

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NeuroScientific Biopharmaceuticals (ASX:NSB) has received feedback and guidance from the US FDA on its planned non-clinical and clinical development program of EmtinB as a treatment for adults with advanced glaucoma via a pre-IND meeting.

The company said meeting completion is an important milestone as it provides regulatory clarity around its proposed Phase 1 trial. The company said it received positive feedback from the FDA on its planned IND-enabling studies to evaluate further toxicology, pharmacokinetics and formulation optimisation for intravitreal administration.

NeuroScientific executive director Tony Keating said, “We are pleased with the guidance and recommendations the FDA has provided. The FDA has answered a number of critical questions related to our non-clinical and clinical development program and provided us with a clear understanding of the design for our Phase 1 trial.

"Furthermore, we confirmed with the FDA, the non-clinical intravitreal administration studies needed to complete an IND application. We will now use this feedback to determine the optimal next steps in progressing EmtinB towards a first-in-human trial. The FDA feedback is critical to our strategy, and we look forward to providing our shareholders with further updates in due course.”