As reported on RTT News, Serina Therapeutics has initiated patient dosing in its Phase 1b registrational study of SER‑252, marking a significant milestone for the company’s lead investigational therapy for advanced Parkinson’s disease.
SER‑252, a POZ‑apomorphine formulation, is built on Serina’s proprietary POZ drug‑delivery platform. The therapy is engineered to deliver continuous dopaminergic stimulation—an approach known to help reduce motor complications such as levodopa‑induced dyskinesia. Earlier this year, the U.S. Food and Drug Administration cleared the company’s Investigational New Drug application, enabling the start of this trial.
The Phase 1b study will assess SER‑252’s safety profile, tolerability, pharmacokinetics, and early signals of therapeutic benefit in individuals whose symptoms remain poorly managed under current treatments. According to the company, the FDA has provided written support for the study design and confirmed the program’s eligibility for a 505(b)(2) New Drug Application pathway, streamlining Serina’s regulatory route.
“With the FDA’s alignment on our registrational strategy, we are well positioned to efficiently generate the data needed to advance SER‑252 toward approval,” said Serina CEO Steve Ledger.
Serina is collaborating with Parkinson’s Australia and Neuroscience Trials Australia to assist with participant recruitment. A review of initial safety data from the first dosing cohort is expected later this year and may allow the trial to progress to its second cohort in the third quarter of 2026.
Parkinson’s disease affects more than 10 million individuals globally, underscoring the need for new therapeutic options. Serina’s POZ polymer platform—based on the water‑soluble synthetic polymer poly(2‑oxazoline)—is being explored for a broad range of applications, spanning small molecules, RNA‑based drugs, and antibody‑drug conjugates.
The company’s pipeline also includes:
- POZ‑lipids, positioned as non‑immunogenic substitutes for PEG‑lipids in lipid nanoparticles
- SER‑214, in development for early‑stage Parkinson’s and restless legs syndrome, which has completed Phase 1a testing
- POZ‑RNA technology for RNA‑based vaccines
- SER‑270, a long‑acting injectable VMAT2 inhibitor for movement disorders including tardive dyskinesia and Huntington’s chorea, expected to complete formulation and pre‑IND work in 2026
Financially, Serina reported a net loss of $4.59 million for the third quarter of 2025, compared with a profit in the same period the previous year. Shares of SER closed at $1.67 on Tuesday, rising further in after‑hours trading.
