A range of neurological and neuropsychological conditions, including anxiety, mood disorders and Fragile X-associated Tremor/Ataxia Syndrome
A range of neurological and neuropsychological conditions, including anxiety, mood disorders and Fragile X-associated Tremor/Ataxia Syndrome
Our programs 1
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
LYT-300
Oral Allopregnanolone
Neuropsychiatric and rare CNS conditions

2a

Neuropsychiatric and rare CNS conditions


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, mood disorders and Fragile X-associated Tremor/ Ataxia Syndrome. Allopregnanolone is a positive allosteric modulator of GABAA receptors that has therapeutic potential across a wide range of neurological conditions, including anxiety and Fragile X-associated Tremor/ Ataxia Syndrome, though its therapeutic application has been limited due to high first pass metabolism. Our Glyph platform reversibly links a drug to a lipid, 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.

A range of neurological and neuropsychological conditions, including anxiety, mood disorders and Fragile X-associated Tremor/Ataxia Syndrome

LYT-300, an oral prodrug of allopregnanolone, is being advanced for the potential treatment of anxiety, mood disorders and Fragile X-associated Tremor/ Ataxia Syndrome. 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, mood disorders and Fragile X-associated Tremor/ Ataxia Syndrome. 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, 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 lipid, 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 drugs that would otherwise be limited by first-pass liver metabolism.
  • Program Discovery Process by the PureTech Team
  • Patient Need & Market Potential
  • Milestones Achieved & Development 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 Zachary Steel and others, The global prevalence of common mental disorders: a systematic review and meta-analysis 1980–2013, International Journal of Epidemiology, Volume 43, Issue 2, April 2014, Pages 476–493, https://doi.org/10.1093/ije/dyu038.
4 Schüle, C., Nothdurfter, C., & Rupprecht, R. (2014). The role of allopregnanolone in depression and anxiety. Progress in Neurobiology, 113, 79–87. https://doi.org/10.1016/j.pneurobio.2013.09.003
Allopregnanolone is a positive allosteric modulator of GABAA receptors that has therapeutic potential across a wide range of neurological and neuropsychological conditions, including anxiety, mood disorders and Fragile X-associated Tremor/ Ataxia Syndrome, though its therapeutic application has been limited due to high first pass metabolism. To overcome this, medicinal chemistry approaches have been applied to synthesize orally bioavailable chemical analogs of allopregnanolone. These oral analogs may have different pharmacological effects than endogenous allopregnanolone and therefore may not capture its full therapeutic potential, though one of them was recently approved in PPD. We believe our Glyph platform should enable us to retain the potency of endogenous allopregnanolone in a more convenient oral form and potentially enable us to unlock the therapeutic potential of allopregnanolone across a range of neurological and neuropsychiatric conditions.