Aachen, Germany (OTE) – Aachen, Germany (ots)
– Potential first-in-class, selective nociceptin receptor (NOP)
agonist that aims to provide safe, effective treatment for moderate
to severe acute pain.
– Following successful Phase I results earlier this year
demonstrating an excellent safety profile, the program has now
progressed to Phase II.
– The randomized, double-blind, double-dummy, placebo- and active
controlled, 2-part Phase II trial will evaluate the safety,
tolerability and efficacy of this novel NOP agonist in patients post
bunionectomy surgery. Grünenthal anticipates reporting results in
early 2028.
Grünenthal announced today that the first patient has been
enrolled in KF7040-21, a Phase II trial to investigate the efficacy,
safety and tolerability of its proprietary nociceptin receptor (NOP)
agonist in adults with moderate-to-severe acute pain following
bunionectomy. The trial is being conducted at sites in the US, with
results expected to be available in early 2028.
The investigational compound has a unique mechanism of action
that selectively engages with the NOP receptor and may represent a
first-in-class therapy option for acute moderate to severe pain.
Earlier this year, the investigational compound was shown to be safe
and well-tolerated in a Phase I trial, supporting progression to
Phase II.[1]
KF7040-21 is a randomised, double-blind, placebo- and active-
controlled Phase II trial comprising a Proof of Concept (PoC) phase
and a dose-ranging phase. Overall, up to 400 participants are
expected to be enrolled. Initially, 96 participants will be included
in the PoC phase. Following completion of this phase, an interim
analysis will inform the decision to proceed to the dose-ranging
phase, in which up to 304 additional participants may be enrolled to
compare three dose levels of the investigational compound with
placebo and an active comparator. Further information can be found on
clinicaltrials.gov.
“The start of this Phase II trial is an important step in our
efforts to provide patients living with pain with novel treatment
options,” says Uli Brödl, Chief Scientific Officer at Grünenthal. “By
selectively activating the nociceptin receptor, our investigational
compound may offer a differentiated approach to deliver safe and
effective pain relief.”
About Bunionectomy
Bunionectomy is the surgical procedure for removing a bunion, an
enlargement of bone and soft tissue that develops on the side of the
foot, which most commonly occurs in the joint at the base of the big
toe: the big toe progressively angles outwards towards the smaller
toes, creating a bony bump (hallux valgus deformity). Bunions may be
caused by hereditary factors, inflammatory arthritic conditions, or
through wearing poorly fitting or pointed shoes that constrict the
toes.[2]
Bunionectomy is accepted by regulatory authorities as a
postoperative hard (bony) tissue pain model in which the analgesic
effect of an investigational compound may be evaluated as a treatment
for acute pain.[3]
About the NOP Receptor
The Nociceptin/Orphanin Receptor (NOP) is a G protein-coupled
receptor whose natural ligand is the 17-amino-acid neuropeptide
nociceptin (N/OFQ).[4] NOP agonists have been shown to act as potent
analgesics without the potential for abuse liability in pre-clinical
models.[5]
