Prior to BIO International Conference, the organisation released a report detailing the state of R&D for the treatment of Alzheimer’s disease and it affirmed the bleak picture for successfully developing a treatment.
BIO’s CEO, Jim Greenwood, summed up where the industry currently stands on the disease area: “The good news is that America’s biopharmaceutical companies currently are conducting 74 clinical-stage programs intended to stop, prevent, or slow the progression of this looming crisis. The bad news is that, while these programs hold real promise, the R&D challenges with this disease are enormous and the level of investment and innovation is not where our nation needs it to be to address this exploding public health crisis.”
The scale of the investment issues can be seen when Alzheimer’s investment is compared alongside oncology, currently the disease seeing the most investment.
During the period 2008 to 2017, companies working on novel oncology drugs raised $12.2bn (€10.9bn) in venture capital, by comparison those working on Alzheimer’s treatment only raised $741m.
Clinical issues
This disparity in funding can be explained by comparative success seen in clinical trials, which is where Alzheimer’s research has struggling – having never seen a disease-modifying treatment approved.
As a result, larger pharma companies have begun pulling resources away from the area, and those that have remained have experienced their own difficulties in achieving success.
According to the report, this has led smaller companies to carry the baton for clinical research, with 77% of Alzheimer’s research carried out by ‘small, emerging’ companies.
As Greenwood mentions, there are 74 clinical-stage programs involving 30 distinct molecular targets, with 10 treatment strategies, including targeting the amyloid and tau pathways.
The major problem remains that unless Phase III projects can start achieving success, the investment required to progress these candidates through the clinic will be limited and history is currently weighing heavily against this.
Reasons to be positive
Despite past failures, however, the report found that early-stage research is still going strong and has not seen a noticeable downward trend over the period 2008 to 2017.
On average, clinical trials investigating disease-modifying Alzheimer’s drugs were approximately 17 per year and Phase I initiations remained largely similar, year-on-year.
In addition, though the area has seen a lack of funding from venture capital in recent years, the report states that funding from the US government has increased, with $1.9bn invested in 2018.
The report calls for more work on such lines to be continued, “More effort upstream is still needed. Continued funding of basic research to advance our understanding of the biology of Alzheimer’s disease will arm drug developers with new targets and approaches to attack this complex disease. Although we now have identified multiple players in the etiology of the disease, the exact detailed molecular mechanism behind Alzheimer’s remains unknown.”
