The Phase I safety and pharmacokinetic study has now been completed. Because virtually no adverse events were reported during the first two cohorts and the lack of toxicity in the bridging toxicology study completed before the Phase I was initiated, we decided to amend the protocol to significantly increase the dose in the third and final cohort. This three-fold higher dose will give us substantially more latitude to explore dose response in both the concussion and Rett Syndrome Phase II trials and to mitigate the potential risk of suboptimal dosing. A final report, including pharmacokinetic data, is expected before the end of September, after which the Phase II trials will be initiated.
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In Rett Syndrome, the therapeutic goal is to restore neuronal function as a way of reducing the symptoms of the condition. Neurons in Rett Syndrome patients have not died or atrophied; they exist in an immature state with impaired intra-neuronal communication, called synaptic plasticity. Deficits in synaptic plasticity are a feature of other autism spectrum disorders (ASDs) as well. The Company is presently evaluating opportunities to expand the NNZ-2566 franchise into other ASDs.
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NNZ-2591
We have allocated some resources to develop a reliable manufacturing process for NNZ-2591 and, as we did with NNZ-2566, to conduct a study with the US Army to elucidate the mechanism of action. These initial steps will inform our future decisions about which indications to pursue and how to position the molecule with respect to commercialisation.
Cheers, Tony
NEU Price at posting:
2.4¢ Sentiment: LT Buy Disclosure: Held
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