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NeuroRestore

In Alzheimer’s disease, the nerve cells cease functioning as they should, which leads to a deterioration of memory and learning. AlzeCure Pharma has identified drug-like substances that stimulate neurotrophic signal pathways and nerve cell function and also improve memory.

NeuroRestore is a platform of symptomatic drug candidates for diseases where cognitive ability is impaired, such as Alzheimer’s.

NeuroRestore stimulates several important signal pathways in the brain, which among other things leads to improved cognition. In preclinical studies with NeuroRestore, we have been able to demonstrate that our drug substances not only boost communication between nerve cells but also improve cognitive ability.

The drug candidates in NeuroRestore stimulate signaling of “neurotrophins,” the most well-known of which is Nerve Growth Factor (NGF) and Brain Derived Neurotrophic Factor (BDNF). The levels of NGF and BDNF are disrupted in many diseases and signaling is reduced. This reduced function impairs communication between the synapses, i.e. the contact surfaces at nerve ends, and reduces the survivability of nerve cells, which gives rise to cognitive impairments. Neurotrophins play a crucial part in nerve cell function, and disrupted BDNF function has a strong genetic association to impaired cognitive ability in several different diseases such as Alzheimer’s and Parkinson’s, as well as traumatic brain injuries and sleep apnea.

In addition to these indications, the same signal pathway is involved in certain eye indications including dry eye syndrome and neurotrophic keratitis, an indication that affect the cornea leading to a gradual deterioration of eyesight. AlzeCure also considers there to be a potential for adding further indications such as depression, as the company has demonstrated good effects from the drug substances in preclinical depression models. The effects in the preclinical studies are comparable to those of the antidepressant drug Prozac.

In several different preclinical models ACD856 has been shown to be able to significantly improve cognitive ability. This, combined with its demonstrated potential to significantly boost BDNF signaling, leads the company to believe that ACD856 could serve as symptomatic therapy in indications with reduced cognitive ability.

In 2019 the company received approval from the Swedish Medical Products Agency and the relevant ethics committee to begin clinical trials with ACD856. In December, treatment of the first individuals was initiated, with the primary endpoint marker being the half-life in humans. The study start is on schedule, with the aim of treating patients who suffer from conditions with cognitive disorders, such as Alzheimer’s. The results of this study are expected to be ready by mid-year 2020.

The video below briefly shows how a compound from the NeuroRestore program acts in the brain.

AlzeCure’s primary drug candidates within NeuroRestore – ACD855, ACD856 and ACD857 – act as enhancers of BDNF/NGF signaling, and the biological mechanism the substances affect enable their use in several different diseases in which the same signal pathway is disrupted. These indications can be grouped into three main categories.

Cognitive impairments linked to:

– Alzheimer’s disease
– Parkinson’s disease
– TBI and other head injuries
– Sleep disruptions
– Complications from major surgery

Depression

Specific eye and ear indications, such as

– Dry eye syndrome
– Impaired hearing

The figure below shows the expected growth in the number of cases of dementia between 2015 and 2050. The largest increase in number of cases of dementia and Alzheimer’s is expected to accur in low and medium income countries (LMIC), since these countries are expected to demonstrate a higher relative improvement in quality of life than high-income countries (HIC), which leads to an increased life expectancy. The need for treatment continues to be very high since there are currently no satisfactory treatment options for such patients.

Number of patients with dementia 2015-2050