18 July 2019 - - UK-based biopharmaceutical company PureTech Health plc (LSE: PRTC) has acquired and plans to develop a clinical-stage product candidate for the potential treatment of lymphatic and immunofibrotic diseases, including lymphedema, the company said.
In preclinical studies, the oral, small molecule candidate, LYT-100, demonstrated anti-fibrotic and anti-inflammatory mechanisms, and in a Phase 1 clinical trial in healthy volunteers, LYT-100 was observed to be well tolerated with a favorable pharmacokinetic profile to support twice daily oral dosing.
LYT-100 expands PureTech's internal R and D pipeline and continues its progress in developing new medicines based on insights into the lymphatic system and local modulation of the immune system for the treatment of immune and central nervous system disorders, lymphatic conditions, and cancers.
Lymphedema is one of the most common lymphatic diseases. It is a chronic condition that afflicts ms of people and is characterised by severe swelling in parts of the body usually in the arms or legs due to the build-up of lymph fluid and inflammation, fibrosis, and adipose deposition.
The most prevalent form of the condition, secondary lymphedema, is frequently caused by cancer treatments or infections resulting in damage to or the removal of lymph nodes.
For example, of the more than 250,000 Americans diagnosed with breast cancer each year, up to one in five who receive surgery will develop secondary lymphedema.
The current standards of care for lymphedema compression and physical therapy are cumbersome and non-curative approaches that cannot correct immune cell infiltration or regenerate the dysregulated lymphatics.
If left untreated, lymphedema can lead to disfigurement, severe pain, disability, infection, and fibrosis. PureTech's product candidate, LYT-100, has the potential to fulfill a widespread need for an effective approach that can treat secondary lymphedema without surgery.
LYT-100, an oral small molecule with well-established preclinical anti-fibrotic activity, has been previously studied in healthy volunteers as part of a Phase 1, single ascending dose study.
PureTech will continue clinical development in healthy volunteers, looking at additional safety and pharmacokinetics of LYT-100 prior to initiating a human biomarker and proof-of-concept study expected in 2020.
LYT-100 was acquired from a large pharmaceutical company where it was originally being developed in another indication.
Lymphedema is a chronic condition characterized by severe swelling of the limbs or other tissues due to the build-up of fluid that would normally be drained by the lymphatic system.
The most prevalent form of the condition, secondary lymphedema, is frequently caused by cancer treatments or infections resulting in damage to or the removal of lymph nodes.
Millions of Americans are affected by the condition, which typically progresses through multiple stages marked by increased fibrosis, limb volume, and tissue changes, ultimately resulting in disfigurement, severe pain, disability, and infection.
The current standard of care for lymphedema include compression, physical therapy, and surgery to help reduce symptoms, but none address the underlying condition.
There are currently no FDA-approved therapeutics to treat lymphedema, suggesting a major need for millions of patients.
PureTech is an advanced biopharmaceutical company developing highly differentiated medicines for dysfunctions of the Brain-Immune-Gut axis.
The company has gained deep insights into the connection between these systems and the resulting role in diseases that have been resistant to established therapeutic approaches.