Priothera Ltd. a yau ta ba da sanarwar cewa Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta ba da izini don ci gaba da aikace-aikacen Kamfanin Binciken Sabon Magunguna (IND) don fara mahimman karatun sa na Phase 2b/3 na mocravimod (mai suna MO-TRANS).

Priothera zai fara nazarin MO-TRANS na duniya Phase 2b / 3 a Turai, Amurka da Japan, yana kimanta inganci da amincin mocravimod a matsayin haɗin gwiwa da kulawa a cikin manya da cututtukan cutar sankarar bargo (AML) marasa lafiya waɗanda ke jurewa allogenic hematopoietic stem cell transplant (HSCT). ). Ana sa ran binciken MO-TRANS zai fara a cikin rabin na biyu na 2022 kuma ana sa ran bayanan farko daga wannan binciken a ƙarshen 2024.

Allogenic stem cell dasawa shine kawai hanyar da za ta iya warkar da marasa lafiya na AML, duk da haka zaɓuɓɓukan jiyya na yanzu suna da alaƙa da babban adadin illa, da yawan mace-mace.

Florent Gros, Co-kafa kuma Shugaba na Priothera, yayi sharhi "FDA IND izinin fara binciken MO-TRANS yana kimanta mocravimod a cikin marasa lafiya na AML da ke jurewa HSCT allogeneic wani babban ci gaba ne ga Priothera. Muna kan hanya don ƙaddamar da wannan muhimmin gwaji na asibiti na Phase 2b/3 kuma muna fatan yin aiki tare da ƙwararrun ƙwararrun masu bincike a duk faɗin Amurka, Turai da Asiya, waɗanda ke raba burinmu na kawo mocravimod ga marasa lafiya a matsayin haɗin gwiwa da kulawa. don AML da yiwuwar sauran cututtukan cututtukan jini.

ABUBUWAN DA ZA KU GUDU DAGA WANNAN LABARI:

We are on track to initiate this pivotal Phase 2b/3 clinical trial and are looking forward to working alongside a large team of enthusiastic investigators across the US, Europe and Asia, who share our goal of bringing mocravimod to patients as an adjunctive and maintenance treatment for AML and potentially other hematologic malignancies.
Priothera will initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult Acute Myeloid Leukemia (AML) patients undergoing allogenic hematopoietic stem cell transplant (HSCT).
The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.