RE:RE:AEZS update next? Robustness and Risks
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Tolerability:
- AIM Biologicals are expected to exhibit excellent tolerability in humans.
- This substantially de-risks the program, as adverse effects are minimized.
- However, efficacy risk remains a consideration.
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Mechanism Validation:
- AIM Biologicals are based on the natural science that allows a mother’s immune system to tolerate fetal antigens.
- Unlike broad immune suppression, AIM Biologicals induce specific immune tolerance.
- This reduces the risk of infections and cancer associated with immune system suppression.
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Preclinical Evidence:
- Positive pre-clinical proof-of-concept has been demonstrated in various in-vitro and in-vivo models.
- The program’s efficacy has been confirmed in ex-vivo studies using human blood samples from both NMOSD and Parkinson’s disease patients.
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Value Accretion:
- Transitioning from the ultra-high-risk preclinical stage to human testing is a significant milestone.
- Human data can accelerate value accretive steps.
- The potential market impact is substantial, addressing diseases with market sizes in the billions.
In summary, Aeterna Zentaris’ AIM Biologicals program represents a promising approach to autoimmune diseases, leveraging natural immune mechanisms. While risks remain, the robust data set developed over years positions this program well for further advancement.