AlzeCure is developing several drug candidates in parallel based on the different research platforms.
- Within NeuroRestore, a new generation of symptomatic therapies is being developed for the treatment of Alzheimer’s.
- Within Alzstatin, disease-modifying and preventive drugs are being developed for the treatment of Alzheimer’s.
- Within TrkA-NAM, new drugs are being developed to treat patients with painful osteoarthritis.
- Within VR1, a new drug is being developed to treat patients with peripheral neuropathic pain.
AlzeCure plans to have two of the company’s drug candidates in clinical trials during 2020. A diversified portfolio of drug candidates paves the way for other indications, such as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson’s disease.
The company has three candidates in the NeuroRestore platform and two candidates in the Alzstatin platform, as shown in the image below. The company is also working on two projects in the field of pain, TrkA-NAM and VR1. The TrkA-NAM project is currently in the preclinical development phase and VR1 is in the clinical development phase.
AlzeCure Pharma’s Pipeline
Research phase: Preclinical discovery and optimization phase. In this phase, potential new drug candidates are synthesized, and their chemical and biological properties are assessed in various in vitro and in vivo test systems. This includes testing of pharmacological effects, pharmacological versus toxicological dose levels, different administration methods and translation to humans.
Pre-clinical development phase: Preparation for clinical studies in humans. The drug candidate undergoes preclinical safety and toxicological tests to determine the tolerability of the drug candidate, adverse reaction profile and maximum dosage level before starting clinical studies. Final formulation work, stability studies and similar work are also carried out. Documentation is compiled and submitted to regulatory authorities and ethics committees for approval before starting clinical studies.
Clinical Phase I: During Phase I, the drug candidate is tested and evaluated from a safety and tolerability perspective, usually in a smaller group of healthy volunteers. The focus from a regulatory perspective is to assess the safety profile, dose levels, how the substance is absorbed, degraded in the body and excreted, as well as evaluating possible interactions with other drugs and food.
Clinical Phase II: In Phase II, the drug candidate is given to patients with the disease to be treated. A primary aim of this clinical phase is to measure efficacy in a relevant patient population, but also to provide additional information on tolerability in the patient population. During this phase, preclinical studies are also being conducted to assess the possibility of giving the drug to pregnant women and children. The intended final formulation for the market is developed.
Clinical Phase III: The aim of Phase III clinical studies is to measure efficacy in a larger patient population with the relevant disease. In Phase III, the efficacy and safety of the drug candidate is confirmed in a patient group that, as far as possible, mimics the population in which the finished drug is to be used, with regard to weight, age, gender, etc. A comparison is made with the current standard treatment of care, or placebo if no standard treatment is available for the disease in question.