TruNoc^™ – Clinical Results

TruNoc has been tested and shown to be well tolerated in two clinical studies as an analgesic in a pain model in healthy volunteers and in hospitalized patients with severe post-partum pain. Proof of concept for TruNoc as an analgesic was also demonstrated in these studies. Each of these studies is detailed below.

In a pain model study in 16 healthy female volunteers, the efficacy of TruNoc as an analgesic was determined by rating the perceived intensity of painful stimuli applied to the right nostril of volunteers. TruNoc was demonstrated to have a dose-dependent analgesic effect of 100 mg comparable to 1,000 mg of acetaminophen (paracetamol).

In a second proof of concept study, 180 hospitalized patients with surgically-induced post-partum pain 48 h after otherwise uncomplicated vaginal delivery were randomized to placebo (n=30), 25 mg TruNoc (n=50), 100 mg TruNoc (n=50) and 1,000 mg acetaminophen (n=50). 100 mg TruNoc was shown to have a comparable analgesic effect to 1,000 mg acetaminophen.

In a safety study in 32 healthy volunteers to investigate gastroduodenal tolerance, TruNoc was reported to have a significantly lower incidence of gastric and duodenal haemorrhages and erosions (ulcerations) compared to racemic Ketoprofen.

While these studies have provided proof of concept for TruNoc in acute pain, Nitec will seek to develop TruNoc for chronic inflammation and pain.

Future clinical trials of TruNoc
Within the next 12 months, Nitec is conducting pharmacokinetic studies in preparation for further clinical development of TruNoc in higher doses. The phase 1 studies are also likely to include an additional pain model to demonstrate proof of concept.

Nitec expects to conduct a phase 2 proof of concept trial for TruNoc in neuropathic pain thereafter. The initial areas of focus are likely to be in neuropathic pain related to diabetes, HIV and herpes virus infection, with diabetic-related neuropathic pain likely to be the first indication to be investigated. Nitec also expects to conduct a phase 2 proof of concept trial for TruNoc in osteoarthritis.