After hours today, Monday August 25, 2025, Serina received very good news from the FDA itself as it relates to the development of its SER-252 (POZ-apomorphine) drug, which is in development for the treatment of patients with advanced Parkinson’s Disease (PD). It was announced that it had received written feedback from the FDA itself that it could initiate a registrational study. A biotech just receiving this news is highly ideal because it can bring it one step closer to potentially receiving U.S. marketing approval of it. However, this communication from the FDA today is far more important because it will allow it to file for approval under something known as the 505(b)(2) NDA pathway.
In essence, this pathway is different from the typical approval pathway in that it makes it so that SER-252 can be filed both as a new drug and as a type where it acts like a generic duplicate. This is an important point to note because apomorphine (marketed as Apokyn) has already been approved by the FDA to improve movement and coordination in PD patients and does so through the release of dopamine. Since this has already been approved by the FDA, what the company does is it modifies the drug in such a way using its POZ technology platform.
Think of this platform as using an improved polymer, poly (2-oxazoline), which can deliver drugs in a load in a continuous, precise manner. The purpose of this is to allow controlled drug delivery to be met exactly with the specific therapeutic profile window of a specific drug. The stable release of drugs allows for it to work but at the same time keeps blood levels stable. Other advantages of this drug are being able to be kept at a stable room temperature, allowing for greater drug loading, and not accumulating in tissues. Lastly, one other important point to mention is that there is no immunogenicity (no severe immune response reaction to the drug or any antibodies fighting back) established with it.
With all this being said, despite this pathway being given, that doesn’t mean that the company won’t have to see successful outcomes from clinical trials. For instance, it was told that it has to put into motion a pharmacokinetic profile bridging aspect to an already approved apomorphine drug. The plan is to file an IND for this advanced PD treatment program in Q4 of 2025. If this intended timeline sticks, then Serina believes that it will be able to initiate a phase 1b study using SER-252 to treat these patients in Q1 of 2026. There is an important differentiation to note, and that is that this phase 1b trial is going to be done in the United States. It has a plan of starting to dose patients in an Australian study (to be used as a global study) at an earlier time period of Q4 2025.
This early-stage study is being designed in mind to have both a single-ascending-dose portion of cohorts and multiple-ascending-dose cohorts. Regardless, the goal is to compare subcutaneous SER-252 to placebo with respect to a few exploratory efficacy measures. With this trial focusing on PD patients who have problems with motor fluctuations, one of the efficacy endpoints being deployed is MDS-UPDRS motor scores. This takes a look at motor movement problems and how they impact a patient in terms of their daily life.
The aspect of using polymer poly (2-oxazoline) as part of the POZ technology is that it can be applied to other modalities far beyond that of only small molecules. With that being said, it can also use this tech towards the development of other classes of drugs that might be improved upon, like antibody-drug conjugates (ADCs), RNA therapeutics, cannabinoids, and many others. In addition, further shots on goal can bet sought out after as part of the 505(b)(2) NDA pathway. With this providing a quicker pathway to approval, it might be able to convince the FDA to allow other drugs in its pipeline to be given this specific drug development pathway. Specifically, the company has other POZ-developed small molecules that might eventually also be afforded this pathway.
Parkinson’s disease is a type of neurodegenerative disorder whereby movement is affected along with a patient seeing tremors. Apomorphine is designed to activate multiple types of dopamine receptors. In other words, it doesn’t just specifically select one subtype, and this offers a differentiated way that patients are treated. What this company has done is take this and apply its POZ technology platform, as I have noted above. The continuous, controlled, sustained release is expected to offer an improved modality, which can be delivered via multiple routes of administration, like intravenous (IV), subcutaneous (SC), or intramuscular (IM).