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Disease modifying Therapy against Alzheimer


Project No: #19883
Capital needed
EUR 5,000,000
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Minimum investment per investor: 1000000
Country: Austria
Reason for needing Capital: Research & Development
Stage: Other
Ideal Investor Role: Equity partner
Highlights: AD04 is safe, cheap, easy to apply and has an excellent intellectual property Position with granted patents in Europe and in the US (and soon in Japan, too).
What you offer to investors?: ADvantage offers 25% Shares for an Investment of €5000000
Business plan:
Executive summary:
Additional documents:






WHO WE ARE

ADvantage is developing a novel
drug, termed AD04, for the treatment of Alzheimer’s disease (AD). Aluminium
oxyhydroxide at a specific dose and therapeutic schedule was used as control in
a previous clinical AD trial, and positively surprised by showing
disease-modifing potential. Our mission is now to provide proof of concept
(POC) by demonstrating its unique features in a prospective, biomarker-based
clinical study.


WHAT WE BELIEVE


During the last decade, no new
drug was approved for AD. Efforts to the development of drugs with
disease-modifying potential were disappointing. However, this is changing  given
novel insights into AD pathophysiology obtained in comprehensive research
programs building on objective biological markers
. ADvantage believes that AD04
represents a new and broadly applicable therapeutic
paradigm
. Given its mode of action (see below), we envisage
disease-modifying activity, thus potential for a true AD drug.


WHY IT
MATTERS


Alzheimer
is a devastating disease that
robs the life of patients and their
families
. Currently, 50 million people are affected by dementia worldwide.
This number doubles every 20 years reaching 131 million in 2050. In fact, AD is
the 6
th leading cause of death in industrialized countries. Patients
lose their memories and independence. Facing the loss of a beloved person
leaves the relatives with guilt, grief and anger. The
socio-economic burden of AD is enormous. Total worldwide cost of
dementia was estimated to US$ 818 bio in 2015. Most of these costs are devoted
to social (40%) and informal (40%) care. The availability of a
disease-modifying drug would
transform
the market
from one that reacts to a debilitating disease to one that helps
preserving the affected individual’s personality and Independence.


MARKET FOR AD THERAPEUTICS




Marketed drugs are the
acetylcholine esterase inhibitors donepezil, galantamine and rivastigmine and,
the N-methyl-D-aspartate (NMDA) receptor antagonist memantine. They are symptomatic drugs only,
and are indicated
for mid-to-severe AD. There is
no drug
approved for earlier disease stages nor one that would exert disease-modifying
activity
. All of the approved drugs are now also available as generics.


Costs spend on these
symptomatic drugs globally are US$ 10 bio, thus representing only 1-2% of the
total societal cost of the disease. This indicates the absence of an effective
therapy and showcases the opportunity.



The AD drug pipeline is rated
modest: 105 agents were tested in 139 clinical trials in 2017 (Phase I: 25
agents, Phase II: 52 agents, Phase III: 28 agents). This compares to 836 agents
tested for cancer in 2016.
The comparatively fast development timeline based
on the repurposing strategy and the intervention point are offering a unique
market opportunity for ADvantage. 
 






THERAPEUTIC PROGRAM



The
AD04 program is based on results made in a Phase II study primarily assessing
another drug candidate in early AD. Data obtained suggest AD04 to slow
shrinkage of the hippocampus, the part of the brain that harbors memory
function(s). This was demonstrated by measuring its volume with a fully
automated, MRI-based system. Importantly, reduced loss of hippocampal volume
correlated with less decline in memory (as compared to controls). Other
disease-driven parameters were also positively affected (e.g., quality of life
of caregivers). Concerning the mode-of-action, AD04 reboosts natural homeostatic pathways involved
in recognition of oxidation-modified lipoproteins and in resolution of
inflammatory responses. Similar mode of action has been shown in animal models
to prevent atherosclerosis. AD04 likely triggers shared pathways involved in
the amelioration of AD as of atherosclerosis.




DRUG
DEVELOPMENT PROGRAM




The clinical development plan
is driven by the repurposing strategy
and integrates AD04’s stage of development and specific indication, early AD.
To achieve marketing authorization, the following principal milestones need to be considered: (1) POC in humans by defining the spectrum
of AD04-triggered biomarker changes, (2) dose/
schedule optimization
by correlating the biomarker profile to positive
changes in clinical endpoints, (3) demonstration
of efficacy
of the optimal dosage. Given the eligibility of AD04 for fast track designation, dose/schedule optimization and efficacy testing
may be done in one pivotal trial using an adaptive design saving precious time.




ADvantage will run a small
study designed to define the spectrum of biomarker changes to deliver POC, i.e.
principal milestone (1) [2-arm study, classical AD04 dosage vs saline, n=20/arm,
endpoints: hippocampal volume, inflammation markers (PET, CSF)]. In parallel, ADvantage
will further validate the mode of action in AD using specific biomarker assays.
After the POC study, ADvantage can be sold in a trade sale process.


AD
Program at a glance:



Intervention
point: reboosts natural homeostatic pathways

Product candidate:
AD04

Stage of development:
mid-stage clinical (repurposing)

Next milestone:
completion of clinical trial demonstrating Proof-of-Concept

Commercial
Opportunity: global AD market, based on symptomatic drugs only, is worth US$ 10
bio. This is to be seen in the context of the total societal cost for AD: US$
868 bio in 2015.


















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