
Serina Therapeutics enrolls first affected person in SER-252 research
Serina Therapeutics has enrolled the primary affected person in its Section Ib registrational research of SER-252 for superior Parkinson’s illness (PD).
The research assesses the security, pharmacokinetics, tolerability and preliminary efficacy of SER-252 in people with superior Parkinson’s whose signs are usually not adequately managed by present therapies.
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The intention is to start dosing sufferers this quarter, in step with earlier steering from Serina Therapeutics.
Serina Therapeutics has established partnerships with Parkinson’s Australia and Neuroscience Trials Australia to assist affected person identification and recruitment actions for the Section Ib trial. The corporate plans to launch additional updates as affected person enrollment progresses.
Steve Ledger, CEO of Serina Therapeutics, stated: “Enrolling our first affected person represents a big operational milestone as we transfer SER-252 into the clinic. Our group has constructed a powerful operational presence in Australia, working intently with main Parkinson’s illness specialists and affected person advocacy organizations to assist environment friendly enrollment.
“Now that the FDA has aligned with our registration growth technique underneath a 505(b)(2) NDA pathway, we’re centered on conducting this research and producing significant medical knowledge for sufferers with superior Parkinson’s illness who face vital unmet medical wants.”
SER-252 is an investigational apomorphine remedy developed utilizing Serina Therapeutics’ POZ platform to offer steady dopaminergic stimulation (CDS).
Serina Therapeutics’ POZ know-how makes use of poly(2-oxazoline), an artificial, water-soluble polymer designed for exact drug loading and managed subcutaneous supply.
Through the use of this know-how, Serina goals to keep up secure drug ranges for therapies with a slim therapeutic window.
The corporate can be exploring broader functions of its POZ platform, together with licensing agreements such because the non-exclusive license with Pfizer for lipid nanoparticle drug supply formulations.