MSD (Merck & Co.) has announced the commencement of the Phase III Shorespan-007 clinical trial of bomedemstat (MK-3543), an investigational treatment for essential thrombocythemia (ET), a rare blood disorder.
Global recruitment for the Shorespan-007 trial has commenced, targeting ET patients who have not previously undergone cytoreductive therapy.
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The randomised, double-blind, active comparator-controlled trial will compare bomedemstat to hydroxyurea, the current standard of care chemotherapy, in approximately 300 patients worldwide.
Assessing the durable clinicohaematologic response rate (CHR) is the trial’s primary endpoint.
Secondary endpoints include the evaluation of fatigue symptoms using the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0), the Patient-reported Outcomes Measurement Information System (PROMIS) Fatigue SF-7a total fatigue score, and the MFSAF v4.0 total symptom score.
The trial will also measure the haematologic remission duration, event-free survival, and the rate of disease progression.
Bomedemstat is a small molecule irreversible LSD1 inhibitor. It is currently being investigated for its potential in treating a range of myeloproliferative neoplasms (MPNs), including ET, myelofibrosis (MF), and polycythemia vera (PV).
The US Food and Drug Administration has granted bomedemstat orphan drug and fast track designations for ET and MF treatment, as well as orphan drug designation for acute myeloid leukemia.
In addition to the Shorespan-007 trial, bomedemstat is being studied in Shorespan-006, another Phase III trial.
It is evaluating the asset against the best available therapy in approximately 300 patients with ET, who have either an inadequate response to or are intolerant of hydroxyurea.
Merck Research Laboratories global clinical development vice-president Dr Gregory Lubiniecki said: “The standard of care in essential thrombocythemia has remained unchanged for decades and patients are in need of new options that have the potential to not only improve disease control, but also improve their quality of life.
“We are rapidly advancing our clinical development programmes with the goal of helping to address these unmet needs and bring more options to patients living with myeloproliferative neoplasms.”
The latest development comes after MSD and GI Innovation entered a clinical trial collaboration and supply agreement to assess GI-102 in combination with Keytruda (pembrolizumab) for various types of cancer.
