LYT-310

Epilepsies and other neurological conditions

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LYT-310

Oral Cannabidiol

Epilepsies & other neurological indications

Phase:
Preclinical

Initial Indications:
Epilepsies & other neurological indications

Patient Population:

Key Differentiations:

Therapeutic candidate designed to unlock the validated efficacy of cannabidiol (CBD). Derived from the Glyph platform, LYT-310 offers oral dosing and the potential for improved tolerability, which could expand the therapeutic application of CBD across a wider range of age groups and indications, including both rare and more common forms of epilepsy and other neurological indications.

More about LYT-310

Phase completed

Phase 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-310 is safe or effective for use by the general public for any indication.

Epilepsies and other neurological conditions

LYT-310, an oral form of cannabidiol (CBD), is being advanced for the potential treatment of epilepsies and other neurological indications. Like LYT-300, we developed LYT-310 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 have poor oral bioavailability.

Key Points of Innovation & Differentiation
- We are developing LYT-310 to offer improved oral dosing and tolerability of CBD. A CBD-based product has received regulatory approval in the United States and Europe to treat seizures resulting from certain rare conditions, but it requires a large volume of a sesame oil-based formulation, which limits its use in broader indications and age groups. LYT-310 could expand the therapeutic application of CBD across a wider range of age groups and indications, including both rare and more common forms of epilepsy and other central nervous system disorders. LYT-310 is designed to:
  - enable oral administration in a capsule or other patient-friendly method of administration;
  - expand the use of CBD into a broad range of therapeutic areas and patient populations (such as adolescents and adults) where higher doses are required to achieve a therapeutic effect;
  - potentially improve safety and reduce gastrointestinal (GI) tract side effects that are associated with the currently approved CBD-based treatment by reduce GI and liver exposure; and
  - allow for a readily scalable, consistent product in a cost-effective manner.
- 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
- We sought out different approaches that could selectively transport therapeutic molecules through the lymphatic system to target cells in the lymph nodes. Based on insights gained internally and via unpublished findings through our network of collaborators, we became aware of a technology being developed at Monash University that had the potential to selectively target the lymphatic system. We obtained an exclusive license to this technology and the related intellectual property. We have since further developed the platform and have generated our own intellectual property associated with the Glyph technology platform.
- We conducted a systematic analysis of compounds and indications that could benefit from the application of our Glyph platform. We prioritized areas of high unmet patient need where the broad application of treatment options with validated efficacy was untapped due to poor oral bioavailability and tolerability. We believe LYT-310 may expand the therapeutic application and potential of CBD across a range of epilepsies and other neurological indications.
Patient Need & Market Potential
- A CBD-based product has received regulatory approval in the United States and Europe to treat seizures resulting from certain rare conditions, but it requires a large volume of a sesame oil-based formulation to achieve therapeutic levels of exposure, which limits its use in broader indications and age groups.
Milestones Achieved & Development Status
- In November 2022, we announced LYT-310 as a new therapeutic candidate leveraging our Glyph platform.
- In multiple preclinical models, including large animal and non-human primate, LYT-310 has demonstrated a three to fourfold increase in oral exposure vs. unmodified CBD in a fasted state. This has the potential to translate into improved safety and reduced side effects. Lymphatic transport has also been confirmed in preclinical models, with up to 30% of LYT‑310 entering the lymphatics, compared to 5% for unmodified CBD – which further supports the novel Glyph mechanism of enhancing bioavailability.
- In December 2023, we announced preclinical data demonstrated LYT-310 was effective in preventing seizures in the Maximal Electroshock Model (MES), a validated and highly translatable preclinical model considered a gold standard for the assessment of antiseizure drugs. LYT-310 was tested against various formulations of CBD, including an oral CBD formulation in sesame oil. LYT-310 showed strong anti-seizure protection activity and was shown to be more effective at preventing seizures at a dose three times lower than an oral CBD formulation. Based on the data, LYT-310 has the potential to expand the use of CBD to broader patient populations, particularly in populations and conditions where higher doses are required to achieve a therapeutic effect.
Expected Milestones
- Initiation of a Phase 1 clinical trial of LYT-310 is expected in the first half of 2024.
Intellectual Property
- Within the extensive Glyph intellectual property portfolio, which covers a wide range of novel linker chemistries, LYT-310 is specifically covered by one patent family comprising one US patent application and four foreign patent applications as of December 31, 2022, which is co-owned with Monash University. Any patents to issue from these patent applications are expected to expire in 2038, exclusive of possible patent term adjustments or extensions or other forms of exclusivity.

Press Releases

November 30, 2022

PureTech Announces New Therapeutic Candidate, LYT-310, an Oral Form of Cannabidiol (CBD) Leveraging PureTech's Glyph™ Platform