A drug treating postpartum depression (PPD) may soon be available to take orally, easing accessibility for patients, thanks to work by Monash University researchers in partnership with PureTech Health plc.
Allopregnanolone remains the only FDA-approved medication on the market used for the treatment of PPD. Currently, it has to be administered as a 60-hour intravenous infusion, to help it break down in the liver.
In Australia, up to 1 in 5 mothers of children aged 24 months or less are diagnosed with depression, yet readily accessible medications to specifically treat PPD remains limited.
That may soon change with this latest announcement, with the researchers reporting they have generated data using ‘LYT-300’, an oral form of allopregnanolone, to create a pill that has the potential to dramatically increase practicality and usability.
Professor Chris Porter and his team at the Monash Institute of Pharmaceutical Sciences developed the new drug delivery technology, ‘GlyphTM’ which showed that when the drug was administered via the platform, systemic blood levels were roughly nine-fold greater than that of orally administered allopregnanolone, based on past data.
The platform uses the human body’s lipid absorption pathways, targeting drug absorption to the lymphatic system and away from the liver.
The Glyph technology is licensed to commercial partner PureTech Health plc, a clinical-stage biotherapeutics company specialising in highly differentiated medicines for devastating diseases, including PPD.
As the first clinical validation of the Glyph technology in humans, Professor Porter and the Monash team, led by Associate Professor Natalie Trevaskis, believes this new discovery is a key milestone.
“These data show that allopregnanolone can be successfully administered orally, which is very encouraging not only for women with PPD, but also for those with other neurological and neuropsychiatric conditions, including other forms of depression, anxiety and sleep disorders, who could benefit from an oral form of allopregnanolone,” he said.
“Because Glyph re-routes drug transport via the lymphatic system, it has the potential to enhance the bioavailability of orally administered drugs like allopregnanolone.”
“Since it selectively traffics therapeutics into the lymphatic system, it has the potential to target therapies to the immune system. We are hopeful that LYT-300 will be the first of many applications for Glyph.”
Julie Krop, M.D., the Chief Medical Officer of PureTech, also noted the possibilities in the new treatment.
“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,” she explained.
The next stage in the multi-part program of LYT-300 will be to evaluate safety and tolerability across a range of doses, and then to identify a dose to take forward.
With the scientists having now proved the successful extent the substance can be absorbed into its intended biological destination, additional dose exploration and the effect of food on oral absorption of the prodrug are now being determined.