PureTech Meets Milestone of Achieving Oral Bioavailability of Allopregnanolone in Healthy Adults Dosed with LYT-300 – QNT Press Release


LYT-300 achieved systemic blood levels approximately nine-fold greater compared to previous reports with oral allopregnanolone.1 Allopregnanolone is a neurosteroid with proven efficacy that is currently only approved as a 60-hour intravenous infusion.

LYT-300, an orally administered prodrug of allopregnanolone, is designed to be differentiated from synthetic analogs, which may not replicate the full target engagement profile of natural allopregnanolone.

These clinical data establish proof-of-principle for PureTech’s Glyph™ platform for enabling oral administration of a range of therapeutics.

PureTech Health plc (NASDAQ:PRTC, LSE: PRTC)) (“PureTech” or the “Company”), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercializing highly differentiated medicines for devastating diseases, today announced the achievement of proof-of-principle for its Glyph ™ platform in a healthy adult study of LYT-300 (oral allopregnanolone), PureTech’s wholly-owned therapeutic candidate for the potential treatment of a range of neurological and neuropsychological conditions. This is a key milestone for the candidate, which is designed to overcome the normally poor oral bioavailability of allopregnanolone to deliver its proven efficacy via simple, convenient oral dosing. This is also the first mechanistic proof-of-principle in the clinic for PureTech’s Glyph lymphatic targeting platform, which is designed to bypass first-pass metabolism to help maximize the therapeutic potential of validated targets and drugs where oral bioavailability has been a barrier. The Glyph platform is also designed to have additional applications through its ability to selectively traffic therapeutics into the lymphatic system, potentially enabling more direct targeting of the immune system.

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PureTech announced the achievement of proof-of-principle for its Glyph™ platform in a healthy adult study of LYT-300 (oral allopregnanolone), PureTech’s wholly-owned therapeutic candidate for the potential treatment of a range of neurological and neuropsychological conditions. (Graphic : Business Wire)

“Natural allopregnanolone has demonstrated efficacy for the treatment of postpartum depression (PPD) and other neuropsychological conditions, but up to now has required IV delivery due to high first-pass liver metabolism. LYT-300 is designed to unlock the validated pharmacology of natural allopregnanolone with a potential oral treatment option for PPD and a range of other neurological and neuropsychological conditions,” said Julie Krop, MD, Chief Medical Officer of PureTech. “Achieving significant systemic exposure of allopregnanolone with orally administered LYT-300 is also a key validation for our Glyph lymphatic targeting platform and represents proof-of-principle for being able to administer drugs orally that currently require IV administration due to first-pass liver metabolism.”

PureTech has previously presented data in non-human primates with LYT-300 demonstrating significantly greater oral bioavailability than orally administered allopregnanolone. Data from this Phase 1 program reaffirmed this finding in humans, showing bioavailability of allopregnanolone that was approximately nine-fold greater than that of orally administered allopregnanolone, based on previously published data.1 In the PureTech study, fasted healthy adults were given LYT-300 containing the equivalent of 53 mg of allopregnanolone, achieving plasma exposure levels with an AUCinf of 352 ng*hr/mL. This represents a nine-fold increase in dose-adjusted exposure when compared to a previously published study in fasted healthy adults in which 30 mg of allopregnanolone was orally dosed, resulting in an AUCinf of 21 ng*hr/mL.1

Allopregnanolone is a natural neurosteroid with well-established biology that has demonstrated efficacy for the treatment of epilepsy, depression and other neurological indications, but its poor oral bioavailability has limited …

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