PhaseBio Pharmaceuticals has filed a patent for a mathematical model that explores the relationship between PB2452, ticagrelor, and its active metabolite. The model aims to determine dosing regimens of PB2452 to reverse the antiplatelet effects of ticagrelor in specific patient populations. GlobalData’s report on PhaseBio Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on PhaseBio Pharmaceuticals, hormone-based therapies for metabolic disorders was a key innovation area identified from patents. PhaseBio Pharmaceuticals's grant share as of June 2023 was 1%. Grant share is based on the ratio of number of grants to total number of patents.
Modeling dosing regimen of an antibody for platelet aggregation
A recently filed patent (Publication Number: US20230192895A1) describes a method for modeling, simulating, and determining an effective dosing regimen of an antibody or fragment that binds to an inhibitor of P2Y12 receptor signaling or P2Y12 receptor-induced platelet aggregation in a patient population. The method involves determining a pharmacokinetic-pharmacodynamic (PK/PD) model that characterizes the relationship between ticagrelor and ticagrelor active metabolite (TAM) individually versus P2Y12 receptor-induced platelet aggregation and P2Y12 receptor signaling.
Based on the determination of the PK/PD model, the method predicts an effective dosing regimen. If the model indicates a decrease in P2Y12 receptor-induced platelet aggregation and signaling, the predicted regimen is a higher dose of the antibody or fragment infused at a faster rate or over a longer period of time. Conversely, if the model indicates an increase in P2Y12 receptor-induced platelet aggregation and signaling, the predicted regimen is a lower dose of the antibody or fragment infused at a slower rate or over a shorter period of time.
The dosing regimen is designed to increase P2Y12 receptor-induced platelet aggregation and signaling values towards the baseline observed before administration of the inhibitor of the P2Y12 receptor signaling. It is also effective in sustaining the increase of P2Y12 receptor-induced platelet aggregation and signaling. The method utilizes various methods to determine P2Y12 receptor-induced platelet aggregation and signaling, such as light transmittance aggregometry (LTA), VerifyNow™-based P2Y12 reactivity units (PRU), vasodilatory stimulated phosphoprotein (VASP) phosphorylation, and other platelet-function or P2Y12-receptor-signaling assays.
The method also models the metabolism of ticagrelor to TAM as a function of the concentration values of the antibody or fragment. The predicted effective dosing regimen may include an initial bolus followed by a higher rate infusion, and then a slower rate infusion. The values of P2Y12 receptor-induced platelet aggregation and signaling necessary for the intended patient population are maintained for a specific duration, ranging from 1 to 48 hours or 10-30 hours.
The dosing regimen aims to provide complete reversal of the inhibitor of P2Y12 receptor-induced platelet aggregation and signaling, with sustained reversal for at least 20 to 24 hours. Administration of the antibody or fragment restores platelet function, including platelet aggregation or platelet receptor signaling, to at least 80% of baseline within 1 minute to 60 minutes of administration. The restoration of platelet aggregation or platelet receptor signaling is sustained for at least 12 hours after administration.
In summary, this patent describes a method for determining an effective dosing regimen of an antibody or fragment that binds to an inhibitor of P2Y12 receptor signaling or P2Y12 receptor-induced platelet aggregation. The method utilizes a PK/PD model to predict the dosing regimen based on the observed changes in platelet aggregation and signaling. The dosing regimen aims to restore platelet function and sustain the reversal of the inhibitor for a specific duration.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies
