AlzeCure is developing five drug candidates within the research platforms NeuroRestore and Alzstatin. The company is also working on a preclinical project within the field of pain – TrkA-NAM.
- The NeuroRestore platform is developing a new generation of symptom-relieving drugs for the treatment of illnesses with cognitive disorders, such as Alzheimer’s disease. There are also possibilities for other indications for this target mechanism, including eye indications.
- Innovative disease-modifying and preventive drugs for Alzheimer’s disease are under development within the Alzstatin platform.
- The TrkA-NAM project is aimed at treating severe pain in indications such as osteoarthritis, which today lacks sufficiently effective treatment.
AlzeCure plans to have two of its drug candidates in clinical trials during 2020. A diversified portfolio also offers prospects for other indications such as sleep apnea, cognitive disorders from traumatic brain injuries and Parkinson’s disease.
The company has three candidates in the NeuroRestore platform and two candidates in the Alzstatin platform. The TrkA-NAM program is currently in a preclinical 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.