NeuroScientific Biopharmaceuticals Ltd (ASX: NSB) has obtained positive results from recently completed off-target safety assessment of its lead drug candidate EmtinB.
The trials involved a comprehensive in vitro screening programme to predict drug-induced toxicities in humans prior to first-in-human Phase I clinical studies.
The preclinical in vitro screening programme was undertaken by leading contract research company Eurofins CEREP, France.
Off-target safety assessments help to identify unintended interactions between a drug and a host of biological targets that are known to cause adverse side effects and toxicities in humans (anti-targets).
The key safety guidance document for drug development, The International Conference on Harmonisation Guidance for Industry (ICH) S7A, recommends completing off-target safety assessments in addition to pivotal safety studies in animals as part of risk mitigation strategies in the design and conduct of first-in-human clinical studies.1
NeuroScientific’s Managing Director and CEO, Matt Liddelow said that of 173 biological targets screened, EmtinB did not interact with any “anti-targets” (known causes of human toxicities), demonstrating the low potential for EmtinB to cause drug induced adverse reactions or toxicities in humans.
These positive safety results add further confidence to existing safety data for EmtinB in demonstrating its low liklihood to cause any major safety issues in humans and is another major step towards achieving the landmark milestone of starting first-in-human Phase I studies in the first half of 2022. I look forward to updating the market with further progress in the New Year as we advance towards Phase I clinical studies,” Mr Liddelow said.
EmtinB is a peptide-based compound that binds to surface-based cell receptors from the LDLR family, activating intracellular signalling pathways that stimulate neuroprotection, neuroregeneration and modulate neuroinflammation.
EmtinB is modelled on a specific active domain of the complex human protein called Metallothionein-IIA, which is produced as part of the human body’s innate immune response to cell injury.
Preclinical research has established that EmtinB is highly specific and selective for its target receptor, safe and well tolerated at high concentrations, and is able to penetrate the blood brain barrier. A series of Phase I clinical studies will be conducted to establish the safety profile of EmtinB in humans.