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REPRINT FROM AUGUST 2, 2010
BioCentury
Arcion’s improved (noci)reception
By Michael Flanagan
Opioids are associated with nausea, drowsiness and the risk Senior Writer
Arcion Therapeutics Inc. is hoping to improve on both
Arcion’s ARC-4558 is a 0.1% gel formulation of clonidine, a the efficacy and safety of systemic therapies for diabetic neuropa- direct-acting adrenergic receptor alpha 2 (ADRA2) agonist. The thy by combining a topical approach with a screening test to gel is designed to deliver the agent directly through the skin, identify patients with increased nociceptor expression. The “where it acts on the terminal end of irritable nociceptors or hyperactive pain fibers” to provide pain “What has begun to emerge
in the neuropathic pain
field is the concept that
the disease involves
Campbell said. Topically targeting abnor- that patients often have problems with the two phenotypes.”
mally sensitive pain fibers “provides a side effects on top of the fact that efficacy is highly uneven,” said President and CEO James Campbell,
should allow for a better safety and toler- James Campbell. “A lot of patients who are Acrion Therapeutics
ability profile with efficacy that is at least on par with the marketed agents,” he said.
Oral drugs commonly prescribed for diabetic neuropathy betic neuropathy, said COO Kerrie Brady, ARC-4558 has include Lyrica pregabalin, a GABA receptor agonist from Pfizer
potential for “use as a standalone first-line agent or as an add- Inc., and Cymbalta duloxetine, a selective serotonin and nore-
on for patients who are currently stabilized on oral medication pinephrine reuptake inhibitor (SSNRI) from Eli Lilly and Co.,
but not getting sufficient pain relief.” The initial clinical work with ARC-4558 was conducted by Side effects on Lyrica’s label include dizziness, somnolence, Curatek Pharmaceuticals L.P., which moved it into a Phase
dry mouth and peripheral edema, as well as more serious risks III trial in patients with post-herpetic neuralgia and diabetic such as angioedema, hypersensitivity reactions, seizures and neuropathy in 2000. The compound did not meet the primary suicidality. Cymbalta carries warnings about nausea, somno- endpoint of pain relief from baseline and Curatek later shifted its lence, insomnia and dizziness, as well as a possible risk of focus to the dermatology space. Arcion purchased the assets in hepatotoxicity, orthostatic hypotension, abnormal bleeding, DAVID FLORES
KAREN BERNSTEIN, Ph.D.
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BioCentury, THE BERNSTEIN REPORT ON BIOBUSINESS REPRINT FROM AUGUST 2, 2010
Product Discovery & Development,
involve other receptors in addition to the both validate the screening tool and test cotic withdrawal, attention deficit hyper- more effective in patients with preserved activity disorder (ADHD), hot flashes as- interpret the results, but after I went back sion. It is also approved as an oral tablet clear positive signal there,” said Campbell.
efficacy signal by focusing on a subset of patients with moderate to severe diabetic the neuropathic pain field is the concept that the disease involves two phenotypes.
correlation” between a patient’s ratings or below the detection limit, and are far pain originating in the nociceptors or pain nociceptor expression. The results showed hypertension,” which is supported by re- fibers that are expressed in the skin, in which case a topical therapy makes sense,” sponse to the capsaicin stimulus test, he Regarding efficacy, the study’s statisti- proximal levels of the peripheral nervous system, such as the spinal cord, or in some relationship between pain relief and skin cases even the central nervous system,” in company will look to raise an undisclosed which case a systemic therapy is likely to patients with nociceptor expression.
Arcion’s hypothesis is that ARC-4558’s success hinges on identifying patients with Phase III testing, which is slated for 4Q10 higher levels of nociceptor expression in the 180-patient intent to treat population (p=0.069), the compound was significantly more effective in patients with nociceptor 500 patients with increased levels of noci- pany devised a test that involves putting a expression (p<0.05). In addition, the level ceptor expression identified using the same of pain relief increased in patients with on a distal part of the leg, covering it for Arcion Therapeutics Inc., Baltimore, Md.
“The key thing about the capsaicin test Curatek Pharmaceuticals L.P., Buffalo
is that it stimulates the same type of pain fibers in the skin that we are looking for Pfizer Inc. (NYSE:PFE), New York, N.Y.
clonidine to act on. Other tests involving Eli Lilly and Co. (NYSE:LLY), Indianapolis,
skin pricks, vibrations or reflex stimuli

Source: http://www.arciontherapeutics.com/news/press/documents/Arcion_Prod_080210.pdf