Periodic Reporting for period 1 - AmInnovation (Disruptive Innovation to Treat Alzheimer’s and Parkinson’s diseases: new target, new patented drug, new therapeutic strategy.)
Reporting period: 2019-06-01 to 2019-11-30
- The candidate therapeutic agent AmyP53 has been synthesized under strictly controlled conditions and fully characterized for chemical and biological properties.
- It has been administered at very high doses in male and female rats via the intravenous and intranasal routes.
2. Main results achieved
- Pure synthetic AmyP53 is highly soluble in water and can be formulated as a nasal spray compatible with therapeutic use.
- All animals treated with AmyP53 were healthy and did not display any sign of toxicity in regular preclinical studies, whatever the dose of AmyP53 tested.
- In particular, all AmyP53-treated animals were found similar to control untreated animals for body weight, food consumption, behaviour, blood markers, major organs function and histology including brain, liver, and kidney.
Therefore, all the objectives of the approved AmInnovation program were successfully achieved. In particular, the intranasal administration of AmyP53 was totally de-risked, which was a key prerequisite for developing our solution against Alzheimer’s & Parkinson’s diseases with a nasal spray treatment.
The follow-up of this study will thus to investigate the safety and pharmacokinetics of Amy53 administered through the nasal route and implement a first in-man (clinical trial Phase 1/2 with patients). By the meantime, the data obtained during the AmInnovation SME Phase 1 H2020 grant will be published in a scientific journal in 2020 and the European Commission will be acknowledged.