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(Alliance News) - PureTech Health PLC on Wednesday touted the efficacy of its acute myeloid leukaemia therapy, after securing a regulatory designation from the US Food & Drug Administration.
According to the Boston, US-based biotherapeutics company, the FDA has granted orphan drug designation to LYT-200 for the treatment of acute myeloid leukaemia, or AML.
LYT-200 is PureTech's monoclonal antibody, which is designed to target Galectin-9, an immunosuppressive protein and oncogenic driver in leukaemia cells.
The therapy is being developed as a potential novel treatment for haematological malignancies, and is currently being evaluated in an ongoing Phase 1B clinical trial in relapsed and refractory acute myeloid leukaemia and myelodysplastic syndrome.
Orphan drug designation, which the FDA has granted to LYT-200, qualifies PureTech for incentives under the Orphan Drug Act. These include tax credits for some clinical trials, as well as eligibility for seven years of market exclusivity in the US, if the drug is approved for AML.
"The current long-term survival rates of patients with relapsed or refractory AML are very poor, and there remains a tremendous unmet need for more effective therapies," said Amir Fathi, director of the Leukaemia Programme at Massachusetts General Hospital, and lead investigator of the trial.
PureTech Health shares were trading 1.2% higher at 204.00 pence each in London on Wednesday afternoon.
By Holly Beveridge, Alliance News reporter
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