The therapy is well-tolerated in allogeneic haematopoietic cell transplantation (HCT) patients.
Priothera – a company focusing on the development of its S1P receptor modulator compound – has announced positive data from the phase 1b clinical trial evaluating mocravimod.
Mocravimod is a sphingosine 1 phosphate receptor modulator, which has been previously tested in multiple autoimmune indications and is being developed to enhance the curative potential of HCT.
The treatment involved allogeneic haematopoietic cell transplantation patients and assessed the safety and tolerability of mocravimod. The secondary objectives were to establish the pharmacokinetic profile of the drug as well as to assess GvHD-free, relapse-free survival at six months following the last treatment.
The research discovered that mocravimod can safely be added to standard treatment regimens in patients with haematological malignancies requiring all-HCT. Furthermore, CD4+ T cells were more sensitive to mocravimod treatment than CD8+ T cells.
Mocravimod resulted in a considerable reduction of circulating lymphocyte numbers and had no negative impact on engraftment and transplant outcomes. Meanwhile, a global phase 2b/3 study assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in acute myeloid leukaemia patients is due to begin in the coming months.
Elisabeth Kueenburg, chief medical officer at Priothera, explained: “Mocravimod’s mode of action has already been well established in autoimmune indications, and the phase 1b trial shows that its potential also extends to haematology.”
“We believe mocravimod has the potential to be a first-in-class therapy in maintaining graft-versus-leukaemia responses, one of the most serious complications of allogeneic HCT, while preventing graft-versus-host disease,” she added.
Florent Gros, co-founder and chief executive officer of Priothera, concluded: “The positive phase 1b data reinforces the potential for mocravimod to improve survival outcomes for patients with haematological malignancies requiring HCT. We’re looking forward to building upon this foundation with our upcoming pivotal phase 2b/3 trial and advancing our lead asset towards its next significant milestones.”