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The Evolution of Drug Development: How AI is Changing the Game
Artificial intelligence has made incredible strides in recent years. However, it has yet to successfully create a blockbuster drug from start to finish. The journey from conceptualization to pharmacy shelves remains unachieved.
Despite this, AI’s contributions to the drug development process are significant.
A recently approved therapy illustrates AI’s role in drug development. Back in the early 1990s, Eli Lilly and Co. (LLY) in collaboration with a partner, introduced xanomeline. Initial trials showed promise in slowing cognitive decline in Alzheimer’s patients and alleviating delusions and hallucinations associated with the disease.
However, xanomeline faced a critical hurdle. The side effects were so severe that over 50% of participants in Phase 2 trials dropped out, leading to the drug being shelved.
But this isn’t where the story ends…
As I have noted in previous articles, AI in healthcare is a significant theme this year. In today’s Smart Money, we will explore how AI helped resurrect xanomeline and whether investing in this technology is worthwhile.
Nearly ten years later, Boston-based PureTech Health PLC (PRTC) took an interest in xanomeline. Their research revealed that while xanomeline effectively targeted certain brain receptors, it induced side effects by affecting receptors outside the brain. This meant solutions were within reach, leading PureTech to acquire the rights to the drug from Lilly.
PureTech’s team identified 65 potential binders and 114 suppressors to mitigate xanomeline’s side effects. They recognized that testing all 7,410 combinations was impractical.
To navigate this complex issue, PureTech employed predictive algorithms, a form of AI. While the specific methods remain confidential, their AI successfully identified an optimal solution: trospium chloride, an already FDA-approved drug for bladder control.
Trospium chloride not only minimizes xanomeline’s adverse effects but allows its therapeutic benefits to operate in the brain. Although we have yet to determine if this combination will treat Alzheimer’s, it has effectively reduced delusions and hallucinations, showcasing potential in treating schizophrenia.
The pivotal results emerged from a groundbreaking Phase 2 trial in 2019.
You may wonder why we continue to discuss PureTech, given its market cap of around $500 million, which pales in comparison to larger pharmaceutical giants.
In fact, PureTech spun off the division responsible for this innovation into Karuna Therapeutics.
In late last year, Bristol-Myers Squibb Co. (BMY) – valued at $115.2 billion – acquired Karuna for a substantial $14 billion. Bristol-Myers secured FDA approvals for schizophrenia treatments just last month.
The significance of this drug, now called Cobenfy, cannot be overstated. Analysts view Cobenfy as the first truly innovative schizophrenia medication in over 30 years. Cantor Fitzgerald predicts it could generate over $1 billion in annual revenue by 2026.
Furthermore, Bristol-Myers intends to further research Cobenfy for its original Alzheimer’s applications and for bipolar disorder. Analyst Paul Matteis of Stifel estimates this expansion could propel peak annual sales to $10 billion, potentially totaling over $100 billion in lifetime sales.
If these projections materialize, Bristol-Myers’ initial $14 billion investment would seem negligible.
Such advancements highlight the transformative potential of AI in drug development. As technology continues to evolve, even greater innovations are anticipated in the coming years.
In Fry’s Investment Report, I often recommend AI healthcare leaders, including Bristol-Myers, which I added to my portfolio in February. Since then, its stock has risen by over 10%.
I’m actively searching for the next wave of AI healthcare leaders.
To discover more about the AI healthcare stocks I endorse, join me at Fry’s Investment Report today.
Next, let’s review what we’ve discussed in Smart Money this past week…
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