A small pharmaceutical company in Research Triangle Park is considering its next steps after seeing positive results in a clinical study evaluating its treatment for Alzheimer's disease.
In a recent phase 2 study, T3D Therapeutics saw results that suggest the company's lead product candidate can be disease modifying in advanced stages of Alzheimer's. This is a disease area with a lot of focus in the pharmaceutical industry and an estimated patient potential of more than 6 million Americans.
With these results, the next step for the clinical program, called T3D-959, is a phase 3 study, which would require additional resources. The company, founded in 2013, has five employees, including CEO John Didsbury. While the company has an office in RTP, it has operated virtually since its formation, working with contractors and a scientific advisory board to move its program forward. But this model wouldn't be sustainable for a larger, capital-intensive phase 3 study.
The company is evaluating multiple avenues to move forward, Didsbury said. T3D Therapeutics could either try to secure a partnering arrangement or position itself as an acquisition target of a larger pharmaceutical company. Alternatively, T3D could pursue development on its own. This would require bringing in capital through granting agencies or private equity. The company is also evaluating a potential IPO to access capital through the public markets.
"All of those options are on the table," Didsbury said.
Didsbury declined to provide details on whether T3D is involved in conversations about potential partnerships or an acquisition. However, he said the company expects to have a defined path forward by the end of the first quarter of next year.
T3D has raised about $30 million since its formation, including about $6 million last year, according to filings with the U.S. Securities and Exchange Commission. The company in 2019 completed a $15 million funding round and secured a $9 million multi-year grant from the National Institute on Aging to support its phase 2 study.
Alzheimer's disease is an area of medicine that's gaining momentum and investment. T3D's phase 2 study was one of 187 clinical trials assessing 141 potential Alzheimer's disease treatments as of January 2023. That number of trials was the most ever on record.
Large pharma companies are investing in the Alzheimer's disease space, leading to the first new therapeutics in about two decades.
Biogen (Nasdaq: BIIB) and Eisai Co. in July received traditional approval for a treatment called Leqembi. The companies also received accelerated approval from the U.S. Food and Drug Administration for the drug Aduhelm in 2021. At the time of its approval, the FDA said Aduhelm was the first novel therapy approved for Alzheimer's disease since 2003.
Eli Lilly and Co. (NYSE: LLY) earlier this year disclosed positive results from a phase 3 study showing that its drug, donanemab, "significantly slowed cognitive and functional decline" in patients with early symptomatic Alzheimer's disease. The company expects the FDA to complete its review of the drug in the first quarter of 2024.
Despite its place as a small company competing with the likes of Biogen and Eli Lilly, Didsbury sees some competitive advantages for T3D's lead program. The company's drug can be delivered orally, rather than through an injection. Additionally, T3D is evaluating its drug in patients with "mild to moderate" Alzheimer's disease, as compared to earlier stages of the disease. Didsbury added that company also thinks its drug has the potential for cognitive improvement in patients, instead of slowing down the decline in cognition.
