In the feasibility assessment, Alzinova has progressed from the primary market data collection and analysis, through the synthesis of the results, to the finalisation of the financial and out-licensing targets aligned with an overall business development strategy of the company. The data collected has provided valuable insights into the current trends and opportunities on the market for AD therapeutics, activities undertaken by the competitors and the recent clinical development results. The feasibility assessment has been performed with the support from the SME coach who provided valuable insights into the scope of the analyses.
The main conclusion from the feasibility study is that there exists a clear business opportunity to exploit on the global AD treatment market. Due to the significant market size, low number of existing treatment options, the limited number of new similar drugs in development, and a clear regulatory pathway for drug approval, the AD market provides a unique opportunity for Alzinova and the vaccine ALZ-101.
The launch of immunotherapies targeting clearance of Aβ will not fill the existing gap on this market and the high unmet needs related to treatment options for AD patients are forecasted to remain underserved. Thus, the AD market will remain a lucrative opportunity for pharmaceutical companies developing novel efficacious treatments. This is a business opportunity that Alzinova aims to explore.
The analysis has confirmed that there are no regulatory hurdles that can hamper the validation or the market launch of the drug upon delivery of sound clinical data. Importantly, ALZ-101 may qualify for preferential regulatory approval schemes upon successful conduct of the Phase 1 clinical trial. This may drastically shorten approval time and accelerate milestone payments for Alzinova.
