Aachen (OTE) – Aachen (ots)
– The investigational compound has a unique mechanism of action and
the potential to become a first-in-class therapy option for the
treatment of acute and chronic pain.
– In a Phase I trial, the investigational compound was demonstrated
to be safe and well tolerated.
– A Phase II trial will commence later this year.
Grünenthal announced today that the company successfully
concluded a Phase I trial evaluating the safety and tolerability of
its proprietary NOP agonist. In the trial, which involved 113 healthy
participants, the compound was demonstrated to be safe and well
tolerated, with no dose-dependent adverse event pattern observed.[1]
Grünenthal is now planning to progress its NOP agonist into a Phase
II trial that aims to enrol 400 US-based patients undergoing
bunionectomy – a well-established model for evaluating the efficacy
and safety of a compound as a treatment for acute pain. The trial
will commence later this year with results expected in the second
half of 2027.
Through its specific selectivity for the nociceptin receptor,
Grünenthal’s NOP agonist features a unique mechanism of action for
the treatment of acute and chronic pain and may present a first-in-
class therapy option. The compound has the potential to deliver
robust pain relief in a broad range of conditions without the side
effects commonly associated with opioids. During the Phase I trial,
no such adverse events, including somnolence, constipation or
respiratory depression, or events suggesting any abuse liability
potential were observed.
„We are excited about the successful completion of our Phase I
clinical trial and double down on our efforts to bring the compound
to patients“, says Uli Brödl, MD, Chief Scientific Officer at
Grünenthal. „With selective nociceptin receptor activation,
Grünenthal hopes to introduce a new mechanism of action into the pain
treatment landscape and provide patients with a much-needed
alternative therapy option.“
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