Inotrem Granted Access to Priority Medicines Scheme (PRIME) for Its Lead Compound MOTREM™ in the Treatment of Septic Shock

  • European Medicine Agency’s PRIME status is granted to promising
    medicines that may offer a major therapeutic advantage over existing
    treatments or benefit patients with no treatment options.
  • Accessing PRIME will support the optimization of MOTREM’sTM
    development program.

PARIS–(BUSINESS WIRE)–#EMA–Inotrem S.A., a biotechnology company specialized in the control of
acute inflammatory syndromes, today announced that the European
Medicines Agency (EMA) has granted access to its PRIority MEdicines
(PRIME) scheme for its lead product MOTREMTM in the field of
septic shock.

The purpose of PRIME created in 2016 by the EMA is to bring treatments
to patients faster by providing early and enhanced support to medicines
that have the potential to address patients’ unmet needs. Through the
PRIME scheme, Inotrem will be able to optimize the development of its
lead compound and accelerate EMA’s regulatory assessment. The inclusion
of MOTREMTM in the PRIME program was supported by the
following criteria: (i) there is an important unmet medical need for the
treatment of septic shock, (ii) the efficacy of MOTREMTM
could be proven in relevant preclinical models in vivo and (iii)
data from a Phase 1 clinical trial showed tolerance in human subjects.
Inotrem launched this year a Phase 2 multicenter clinical trial with
patients suffering from septic shock in four European countries.

Septic shock is a serious and very debilitating acute condition with
high mortality and associated long-term physical, psychological, and
cognitive disabilities in survivors. Sepsis, which is characterized by
an intense and excessive systemic inflammatory reaction in response to a
serious infection, affects worldwide up to 1% of the population annually
with a mortality rate of 25 to 40% placing it as the 10th leading cause
of death in developed countries and the 1st cause of death in intensive
care units. MOTREMTM is the formulation of the active
ingredient LR12, a synthetic peptide capable of controlling the
amplification loop of the inflammatory response by inhibiting the TREM-1
receptor, and as such brings the potential of improving hemodynamic
parameters and survival rates of septic shock patients. There are
currently no specific therapies approved for this indication, and
Inotrem’s MOTREMTM aims at becoming the first mechanism-based
personalized medicine for septic shock.

EMA’s decision to grant our product the PRIME status is an important
recognition of both Inotrem’s innovative therapeutic approach in the
management of acute inflammation and the critical need for causal
therapies in a severe condition such as septic shock. This is also the
first time a product being developed in the critical care setting is
receiving the PRIME status,
” said Jean-Jacques Garaud, M.D., CEO and
co-founder of Inotrem. “We are very pleased to be part of this
program and look forward to working together with the EMA’s Committee
for Medicinal Products for Human Use with their regulatory support to
pursue our clinical development plan moving toward the MOTREM
marketing authorization process,
” added Margarita Salcedo Magguilli,
CDO of Inotrem.


Anne REIN, +33 6 03
35 92 05