An oral prodrug of allopregnanolone being advanced for the potential treatment of anxiety disorders and postpartum depression
An oral prodrug of allopregnanolone being advanced for the potential treatment of anxiety disorders and postpartum depression
Our programs 1
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
LYT-300
Oral Allopregnanolone
Depression, anxiety & related indications

1

Depression, anxiety & related indications


Designed to overcome the poor oral bioavailability of allopregnanolone to advance what we believe could be a best-in-class new medicine for treating anxiety and depression. Allopregnanolone is a positive allosteric modulator of GABAA receptors that has therapeutic potential across a wide range of neurological conditions, including depression and anxiety disorders, though its therapeutic application has been limited due to high first pass metabolism. Our Glyph platform reversibly links a drug to a dietary fat molecule, creating a novel prodrug. We believe this technology has the potential to provide a broadly applicable means of enhancing the bioavailability of certain orally administered drugs that would otherwise be limited by first-pass liver metabolism.

Phase completedPhase in progress
1 The FDA and corresponding regulatory authorities will ultimately review our clinical results and determine whether our wholly-owned therapeutic candidates are safe and effective. No regulatory agency has made any such determination that LYT-300 is safe or effective for use by the general public for any indication.

An oral prodrug of allopregnanolone being advanced for the potential treatment of anxiety disorders and postpartum depression

LYT-300, an oral prodrug of allopregnanolone, is being advanced for the potential treatment of anxiety disorders and postpartum depression. We developed LYT-300 using our Glyph™ platform, which harnesses the body’s natural lipid absorption and transport process to enable the oral administration of certain therapeutics that otherwise cannot be administered orally.
  • Key Points of Innovation & Differentiation
    • We are developing LYT-300 to advance what we believe could be a best-in-class new medicine for treating anxiety and depression. LYT-300 is designed to overcome the poor oral bioavailability of allopregnanolone. LYT-300 has demonstrated oral bioavailability in healthy adults, achieving blood levels of allopregnanolone at or above those associated with therapeutic effect and nine times greater than orally administered allopregnanolone, based on third-party published data.1 LYT-300 has also demonstrated favorable tolerability in addition to target engagement with GABAA receptors, which are known to regulate mood and other neurological conditions.
    • Allopregnanolone is a positive allosteric modulator of GABAA receptors that has therapeutic potential across a wide range of neurological conditions, including depression and anxiety disorders, though its therapeutic application has been limited due to high first pass metabolism. To overcome this, the industry has developed oral chemical analogs of allopregnanolone, though these may not capture the full therapeutic potential of endogenous allopregnanolone.
    • Our Glyph platform reversibly links a drug to a dietary fat molecule, creating a novel prodrug. The linked fat molecule re-routes the drug’s normal path to the systemic circulation, bypassing the liver and instead moving from the gut into the lymphatic vessels that normally process dietary fats. We believe this technology has the potential to provide a broadly applicable means of enhancing the bioavailability of certain orally administered drugs that would otherwise be limited by first-pass liver metabolism.
  • Program Discovery Process by the PureTech Team
  • Patient Need & Market Potential
  • Milestones Achieved & Developmental Status
  • Expected Milestones
  • Intellectual Property
1 Brexanolone NDA 211371 Multi-disciplinary Review and Evaluation, FDA CDER, 2018.
2 Any Anxiety Disorder. (n.d.). National Institute of Mental Health (NIMH). https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder
3 Any Anxiety Disorder. (n.d.). National Institute of Mental Health (NIMH). https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder
Allopregnanolone is a positive allosteric modulator of GABAA receptors that has therapeutic potential across a wide range of neurological conditions, including depression and anxiety disorders, though its therapeutic application has been limited due to high first pass metabolism. To overcome this, the industry has developed oral chemical analogs of allopregnanolone, though these may not capture the full therapeutic potential of endogenous allopregnanolone. Our Glyph platform reversibly links a drug to a dietary fat molecule, creating a novel prodrug. The linked fat molecule re-routes the drug’s normal path to the systemic circulation, bypassing the liver and instead moving from the gut into the lymphatic vessels that normally process dietary fats. We believe this technology has the potential to provide a broadly applicable means of enhancing the bioavailability of certain orally administered drugs that would otherwise be limited by first-pass liver metabolism.