LYT-100

 

TRIAL PHASE
Product Candidate
PureTech Ownership
Initial Indications
Preclinical
Phase 1
Phase 2
Phase 3
LYT-100
100% (Internal)
Lymphedema

Initial Indication(s):

Lymphedema

Patient Population:

~1 million

Collaborators:

teva  memorialSloanKet

Key Differentiation:

Product candidate for lymphedema with encouraging in-human pharmacokenetics



LYT-100
Lymphedema
100% (Internal)
1

Initial Indication(s):

Lymphedema

Patient Population:

~1 million

Collaborators:

teva  memorialSloanKet

Key Differentiation:

Product candidate for lymphedema with encouraging in-human pharmacokenetics



Novel approach to treating lymphatic flow disorders

PureTech is developing its wholly owned product candidate LYT-100 for the treatment of lymphedema, other disorders of impaired lymphatic flow and conditions involving inflammation and fibrosis. In July 2019, PureTech acquired LYT-100, a small molecule product candidate that was well-tolerated in a Phase 1 clinical trial in healthy volunteers and showed a pharmacokinetic profile suitable for oral administration.

Due to LYT-100’s observed potent anti-fibrotic and anti-inflammatory activity in preclinical models and based on unique insights from PureTech's scientific focus and data from the company's collaborator with a functional analog in a lymphedema preclinical model, PureTech believes LYT-100, if successfully developed and approved, could become a promising treatment for lymphedema.  

 

  • Patient Need & Market Potential
    • Lymphedema is a chronic condition that afflicts millions of people in the United States and is characterized by severe swelling in parts of the body, typically the arms or legs, due to the build-up of lymph fluid and inflammation, fibrosis and adipose deposition.
    • Dysfunctions of the lymphatic system have remained largely untreated or poorly addressed by current therapeutics. Diseases of the lymphatics include lymphedema, lymphatic and vascular malformations, gastrointestinal lymphangiectasia and others. Impaired lymphatic drainage in the tumor microenvironment can promote immune escape and considerably contribute towards lymphatic metastatic spread of cancer. 

    • PureTech believes that neurodegenerative diseases, such as Alzheimer's and Parkinson’s disease, may be treated by correcting aging and inflammation related brain lymphatic dysfunction.

    • There has been little progress toward the development of meaningful treatments for lymphatic diseases, and there are currently no approved drug therapies that can treat disorders such as lymphedema.

    • There has been little progress toward the development of meaningful treatments for lymphatic diseases, and there are currently no drugs approved to treat the  most common lymphatic disease, lymphedema.

    • The current standard of care for lymphedema is management, primarily with compression and physical therapy to control swelling. These approaches are cumbersome, uncomfortable and non-curative, and they do not address the underlying disease, especially in patients with more severe lymphedema. Even with management, some patients will progress from mild-to-moderate lymphedema to more severe forms. Referral to current treatment regimens does not predict reversal or stabilization of lymphedema. In later stages, patients may also seek ablative surgeries, including liposuction or debulking. These surgeries reduce volume but do not restore lymphatic flow, and compression is still required to control swelling.

  • Our Approach to Solving the Problem
    • PureTech believes that targeting the chronic inflammation and fibrosis associated with lymphedema with an oral therapy could potentially treat secondary lymphedema. LYT-100 is a deuterated form of pirfenidone, an approved anti-inflammatory and anti-fibrotic drug. PureTech is developing LYT-100 for the treatment of lymphedema and other lymphatic and fibrotic disorders. LYT-100 was originally developed by Auspex for the treatment of IPF. Auspex was a leader in deuteration chemistry and was acquired by Teva Pharmaceutical Industries in 2015.

    • PureTech selected and acquired LYT-100 in July 2019 based on insights into the lymphatic system gained internally and via unpublished findings through its network of collaborators, coupled with the relationships of PureTech team members and their insights into the program previously developed at Auspex.
  • Intellectual Property
    • LYT-100 is extensively protected by composition of matter patents, as well as patents covering methods of use and process of manufacture for deupirfenidone as well as other claims.
    • As of July 31, 2019, the LYT-100 patent portfolio includes 31 active patents acquired and one patent application licensed from Auspex. These patents and application provide broad coverage of compositions of matter, formulations and methods of use for deuterated pirfenidone, including the LYT-100 deupirfenidone compound, comprising six issued U.S. patents, which are expected to expire in 2028, one U.S. patent application which if issued, is expected to expire in 2035, and 25 patents issued in 23 foreign jurisdictions, without taking into account any possible patent term extension or regulatory exclusivities.
    • PureTech has filed additional patent applications on deupirfenidone, including three U.S. patent applications directed to the use of deuterated pirfenidone, including LYT-100 deupirfenidone, for the treatment of lymphedema and other relevant disorders. Any issued patents claiming priority to these applications are expected to expire in 2039 through 2040, exclusive of possible patent term adjustments or extensions or other exclusivities.
  • Collaborations
    • PureTech’s LYT-100 program is advised by the world’s leading lymphedema experts, including Babak Mehrara, M.D., at Memorial Sloan Kettering Cancer Center and Stanley Rockson, M.D. at Stanford Medicine.
  • Milestones Achieved
    • LYT-100 was studied in a single dose crossover Phase 1 clinical trial of 24 healthy volunteers to assess safety and PK. The results demonstrate that LYT-100 displays improved PK relative to pirfenidone and suggest the possibility of twice-daily dosing of LYT-100 in patients with lymphedema. In addition, LYT-100 was well-tolerated and there were no serious adverse events observed in the Phase 1 clinical trial of healthy volunteers.
  • Expected Milestones and Timing
    • PureTech intends to commence a multiple dose Phase 1 clinical trial followed by a POC study in lymphedema patients for LYT-100 in 2020, with potential readout for the multiple dose Phase 1 clinical trial in 2020 and POC study in 2021.
    • PureTech also intends to evaluate LYT-100 and other potential new product candidates from its meningeal lymphatics platform for a range of neurodegenerative diseases.

PureTech is developing LYT-100 for lymphedema – a debilitating and chronic condition that affects millions of people and is characterized by swelling due to the build-up of lymph fluid and inflammation – and other disorders of impaired lymphatic flow and conditions of inflammation and fibrosis.