Serina-AgeX merger to develop treatment for advanced Parkinson’s
SER-252 (POZ-apomorphine) as weekly injection to target off episodes
The company will continue under the Serina name and expects to submit an investigational new drug application (IND) for SER-252 to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial, which is anticipated to start in the fall of 2024.
“The merger with AgeX positions Serina to advance our CNS [central nervous system] pipeline assets and expand our platform partnering opportunities,” Milton Harris, PhD, cofounder and chair of the board at Serina, said in a press release.
“As a board director of the combined company, I look forward to collaborating with our new partners AgeX and Juvenescence, as we continue the work of translating our science into innovative therapeutics,” he added.
Many therapies have narrow therapeutic dose range that’s safe, efficient
Many therapies, including those used to treat Parkinson’s, have a narrow therapeutic dose range in which they are safe and efficient. They often require more frequent dosing, resulting in large and frequent fluctuations in patients’ exposure to the medications.
These therapies need to be monitored, and their doses need to be adjusted to a higher frequency, adapted to each patient. These fluctuations pose clinical challenges and affect the quality of life of many patients.
Levodopa is one of the main medications used to treat the symptoms of Parkinson’s. It is the precursor of dopamine, which is a chemical used by nerve cells to communicate and is gradually lost in Parkinson’s. Levodopa works by replacing lost dopamine in the brain.
In advanced Parkinson’s, levodopa may cause patients to experience off episodes, periods of time when the medication wears off before it’s time for the next dose. Moreover, this often leads to dyskinesia (involuntary motor movements).
Apomorphine is a medication used to treat off episodes. Its current formulations must be delivered via a subcutaneous (under-the-skin) injection.
SER-252 POZ-apomorphine is made using the company’s proprietary POZ Platform delivery technology. This technology allows for greater control in drug loading as well as rate of release to enable continuous delivery.
It’s meant to be delivered as a single injection once a week and, according to the company, could potentially reduce off time as well as prevent dyskinesia.
Serina to launch preclinical studies for SER-252
Serina will advance preclinical studies on SER-252, before submitting an IND application to the FDA for the initiation of a Phase 1 clinical trial.
“We are delighted to announce the proposed merger with Serina,” said Joanne M. Hackett, PhD, chairperson and interim CEO of AgeX. “We see exciting potential to generate novel drug candidates with the POZ Platform delivery technology.”
Under the terms of the agreement, Juvenescence, an AgeX stockholder, will provide an additional $15 million in capital to the merged company until July 2025.
“Serina merging with AgeX is an important step towards recognizing the potential to develop the POZ Platform to deliver novel medicines and treatment modalities,” said Richard Marshall, MD, PhD, CEO of Juvenescence Limited.