Cerecin on track to develop oral dementia drug

CEO Charles Stacey

Cerecin Inc., a global biotechnology company focused on neurology drug development, is developing a new drug candidate for Alzheimer’s disease in liquid form. This is easier to ingest than injections, which take over an hour to administer, or pills that need to be swallowed, according to Chief Executive Officer Charles Stacey.

“Since dementia is a degenerative disease, the majority of patients are elderly. This is why ease of administration is an important consideration for treatment,” Stacey said during a recent interview with Maeil Business Newspaper. “We are confident that our new drug candidate Tricaprilin (CER-0001) will be a game changer in the field of dementia treatment, which has been dominated by injectable drugs.”

Stacey also emphasized Tricaprilin’s unique qualities. While existing treatments aim to remove amyloid, an abnormal protein, Tricaprilin focuses on resolving metabolic dysfunction by using ketone bodies, a glucose substitute.

“The brain accounts for only 2 percent of human body weight, but it is a highly metabolized region that uses 25 percent of all glucose for energy,” he explained. “If brain metabolism functions properly, memory decline can be prevented, and we are focusing on ketone bodies as the fuel for this.”

Another distinctive feature of Tricaprilin is that it targets Alzheimer’s patients who do not carry the ‘APOE4’ gene, which is often linked to dementia.

”There are 50 million people with Alzheimer‘s worldwide, and 45 to 60 percent of them do not have APOE4,“ Stacey said. “This is more common among Asians, which is why the Asian market is crucial.”

Tricaprilin’s efficacy as an Alzheimer‘s treatment has been demonstrated multiple times.

“In a previous Phase 2 clinical trial, patients who took Tricaprilin daily showed a 156 percent improvement in cognitive scores compared to the placebo group after 45 days, which is encouraging, given that amyloid-targeting treatments take 18 to 24 months to show results,” Stacey noted.

He added that while 20 percent of patients on injectable treatments suffer from brain swelling, Tricaprilin’s side effects are very mild.

Cerecin, founded in 2001 and headquartered in the United States and Singapore, develops neuropharmaceuticals related to ketone bodies. Its largest shareholder is Nestlé Group which holds a 60 percent stake, and Stacey, a surgeon and neuroscientist, has been leading Cerecin since 2015.

Cerecin has identified South Korea as a key country for its Phase 3 clinical trials, which will begin in 2025. Korea accounts for 80 percent of the patients involved in Asia.

“Korea is very important as it has well-established medical institutions, excellent data management, and high patient participation,” Stacey said. “We are currently working with 15 professors to prepare for Phase 3, which will confirm the strong data proven in Phase 2.”

Cerecin’s commitment to Korea is further evidenced by its plans to list on the country’s secondary Kosdaq market in 2025.The company has raised around 40 billion won ($30.18 million) from Korean investors and selected Samsung Securities Co. as a joint lead manager alongside Hana Securities Co. in June, with the help of Partners Investment.

“We considered stock markets in the United States, Hong Kong, and Singapore, but we found Kosdaq to be an attractive option as it is the most transparent, has reasonable regulations, and a high proportion of the biotech industry,” Stacey explained. “We plan to go public in November next year after passing the technology evaluation this November.”

Cerecin also plans to diversify its pipeline by expanding Tricaprilin’s indications to include migraines and infantile spasms (pediatric epilepsy) and has also completed its Phase 2 trials for both conditions.

“We are currently discussing technology transfer for migraines with six major pharmaceutical companies,” according to Stacey.

“We also aim to develop treatments for stroke, traumatic brain injury, and heart failure and commercialize our existing pipeline by speeding up clinical trials over the next one to two years.”