Companies partner on wearable apomorphine injection system

Serina, Enable Injections aim for faster, simpler therapy

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by Andrea Lobo |

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Serina Therapeutics has partnered with Enable Injections to advance SER-252 (POZ-apomorphine), Serina’s lead treatment candidate for advanced Parkinson’s disease, in combination with the enFuse wearable delivery system.

EnFuse is designed to allow patients to self-administer SER-252 subcutaneously (under the skin) in a faster, simpler, and more convenient way than current methods.

“The technology and benefits of enFuse have the potential to significantly reduce many of the burdens associated with the current standard of care for Parkinson’s,” Mike Hooven, chairman and CEO of Enable Injections, said in a company press release. “We greatly look forward to bringing those living with, and treating, Parkinson’s disease an improved treatment experience that is more convenient, less time-consuming, and less disruptive to their lives with SER-252 in combination with enFuse.”

Many therapies — including levodopa, which is used to treat Parkinson’s symptoms — have a narrow therapeutic dose range in which they are safe and efficient.

Levodopa works to replace dopamine, a chemical that nerve cells use to communicate that is gradually lost in Parkinson’s. However, as the disease progresses, patients will require higher and more frequent dosing to control symptoms, resulting in frequent fluctuations in patients’ exposure to the medications.

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Relieving the burden of apomorphine injection

Parkinson’s patients may also experience periods between doses in which symptoms are not well controlled, referred to as off episodes, and uncontrolled motor movements, or dyskinesia.

Apomorphine is a dopamine agonist that mimics the activity of dopamine by binding to its receptors. It’s used to treat off episodes, and is delivered via a subcutaneous injection (sold as Apokyn).

“Current apomorphine treatments require daily and time-consuming infusions through an electronic pump that not only burdens patients and providers, but can cause significant skin reactions,” said Randall Moreadith, MD, PhD, Serina’s chief development officer.

SER-252 is made using Serina’s proprietary POZ platform delivery technology, which is based on a synthetic polymer that incorporates “a predictable amount” of medication to provide controlled loading and release. Medications with narrow therapeutic windows can be designed to maintain adequate, stable levels in the blood, Serina says.

Preclinical studies showed that SER-252 could safely enable continuous drug delivery via a once-weekly subcutaneous injection, according to the company. Based on this data, Serina plans to advance the therapy to clinical testing in 2025.

“With enFuse, patients can self-administer SER-252 in the convenience of their home with wearable technology and with a rapid treatment time,” Moreadith said. “If effective, a SER-252 and enFuse combination provides the potential for patients to remain in a continuous ‘on’ state and avoid dyskinesia.” An on state is when symptoms are well controlled with medication.

Under the terms of the agreement, Serina will obtain a worldwide exclusive license to the enFuse platform, for an upfront and future milestone payments. Enable will also be entitled to product sales and single-digit royalties.

The first enFuse combination product was approved by the U.S. Food and Drug Administration (FDA) in 2023. The device allows people with paroxysmal nocturnal hemoglobinuria to self-administer Empaveli (pegcetacoplan).