LYT-300

 

Our programs
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
LYT-300
Oral Allopregnanolone
Neurological indications

Preclinical

Neurological indications


LYT-300 is an oral form of FDA-approved allopregnanolone, which is currently marketed in the U.S. as ZulressoTM and administrated as a 60-hour intravenous infusion. Despite FDA approval, the 60-hr IV infusion has greatly limited the usage of Zulresso. Achieving oral bioavailability for allopregnanolone, a natural neurosteroid, may enable its usage across a range of neurological conditions.
Phase completedPhase in progress
Targeting neurological conditions by trafficking oral therapeutics via the lymphatic system

LYT-300 is PureTech’s preclinical product candidate targeting a range of neurological conditions. It was born out of the Company’s GlyphTM technology platform, which employs the body’s natural lipid absorption and transport process to orally administer drugs via the lymphatic system.

We are advancing a broad pipeline of programs to treat cognitive deficiency and improve symptoms associated with medical conditions across neurology and psychiatry, including attention-deficit hyperactivity disorder (ADHD), major depressive disorder (MDD), autism spectrum disorder (ASD), multiple sclerosis (MS) and various other neuroinflammatory diseases. We are also developing associated clinical monitors and measurement-based care applications. Our lead, patented technology platform is exclusively licensed from the lab of Dr. Adam Gazzaley at the University of California, San Francisco (UCSF), and augmented by proprietary adaptive algorithms developed by our team.

  • Program Discovery Process by the PureTech Team
    • Given PureTech’s interest in the lymphatic system, the Company sought out different approaches to selectively traffic therapeutic molecules through the lymphatic system to target immune cells in the lymph nodes. This led to the development of LYT-300, a product candidate born out of PureTech’s Glyph technology platform.
  • Innovative Approach to Solving the Problem
    • PureTech is advancing its Glyph technology platform, which employs the body’s natural lipid absorption and transport process to orally administer drugs via the lymphatic system by (1) targeting the mesenteric lymph nodes and (2) bypassing first-pass metabolism. To date, PureTech has evaluated and validated more than 20 molecules as well as a range of novel linker chemistries that have demonstrated promising lymphatic targeting in preclinical studies. The most advanced of these is LYT-300, an oral form of FDA-approved allopregnanolone, which is currently marketed in the U.S. as ZulressoTM and administrated as a 60-hour intravenous infusion. Allopregnanolone is a natural neurosteroid, which PureTech believes may be developed for the potential treatment of a range of neurological conditions by achieving oral bioavailability. Neurosteroids, such as allopregnanolone, are a class of potent endogenous small molecules that have been recognized over the past three decades for their therapeutic potential to treat a range of neurological conditions. However, the translation of these compounds into viable therapeutics has been hampered by a number of factors including:
      • the inability to create an oral formulation due to first pass metabolism by the liver, and
      • the inability to administer them chronically to patients – essential for treating CNS disorders.
  • Intellectual Property

    In addition to its broad intellectual property coverage for its proprietary lymphatic targeting platform, PureTech has intellectual property that specifically covers compositions of matter, methods of use and methods of treatment for various classes of pregnane neurosteroids, including allopregnanolone, that have been developed utilizing PureTech’s Glyph technology.  PureTech’s intellectual property that is specifically directed to LYT-300 (oral allopregnanolone) consists of two patent families, one family comprising an international PCT application and the other family comprising two U.S. patent applications, which is co-owned with Monash University. Any issued patents from these patent applications are expected to expire in 2040 or 2041, exclusive of possible patent term adjustments or extensions or other forms of exclusivity.

     

  • Milestones Achieved
    • PureTech has demonstrated oral bioavailability with LYT-300 in large animals (non-human primates) of over 30 percent and plans to initiate first-in-human clinical studies by the end of 2021. 
    • The Company has continued to collaborate with Boehringer Ingelheim on applying the lymphatic targeting platform in the immuno-oncology space.
  • Expected Milestones
    • PureTech expects to carry out additional preclinical studies with LYT-300 (oral allopregnanolone) to support the initiation of first-in-human clinical studies by the end of 2021.

Lipid prodrugs provide multiple opportunities to enhance small molecule drug distribution 

LYT-300: Oral allopregnanolone for a range of neurological disorders