PISCATAWAY, NJ--(Marketwired - July 01, 2015) -
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An agent previously in clinical development as a topical anti-inflammatory is retargeted for hyperpigmentation using nPharmakon’s computational technology
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First-in-class topically bioavailable selective KIT kinase inhibitor with anti-inflammatory activity (COX / 5-Lipoxygenase inhibitor)
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Statistically significant superiority to vehicle and commercial comparator is seen in both visual scoring and instrumentally measured L*a*b* L values
nPharmakon LLC, a life sciences company focused on “retargeting” -- the identification of previously unrecognized molecular targets of clinically tested therapeutic agents and their subsequent development for new uses -- announced today the results from a clinical study of NPH29, the company’s development candidate for skin hyperpigmentation. In a double-blind, within-subject, nurse-administered 30 day study involving 21 study participants, NPH29 1% cream has demonstrated statistically significant superiority to vehicle cream and the commercial comparator, a best-selling product in Japan with tranexamic acid as the active ingredient, in both visual scoring and instrumentally measured L*a*b* L values (p < 0.005); no adverse events attributable to the NPH29 cream were observed.
“This is a major milestone for our company,” said Dr. Felix Sheinerman, Chief Scientific Officer of nPharmakon. “The NPH29 story demonstrates the potential of the company’s retargeting approach to quickly advance “de-risked” assets from computational predictions to demonstration of activity in pre-clinical models to clinical proof of concept in new indications.”
“There is a great need for safe and efficacious treatments for skin hyperpigmentation conditions with a mechanism of action other than tyrosinase inhibition,” said Dr. Dmitri Rebatchouk, CEO of nPharmakon. “Given the prior clinical history of NPH29 and the new data demonstrating its efficacy in reducing pigmentation, we believe NPH29 can now be rapidly developed and launched as a new treatment for various hyperpigmentation disorders, providing a new option to patients -- articularly to those for whom other treatments have not been effective. Since NPH29 is both a KIT inhibitor and an anti-inflammatory, it could prove to be particularly useful for treatment of peri-inflammatory and post-inflammatory hyperpigmentation, such as hyperpigmentation accompanying acne.”
About skin hyperpigmentation disorders
Skin hyperpigmentation is highly prevalent worldwide, notably in Asia, and in individuals with medium to dark skin tone (Fitzpatrick skin type III to V); skin blemishes of localized hyperpigmentation can be highly distressing and have a material negative impact on the quality of life of the sufferers. Examples of skin hyperpigmentation disorders include post-inflammatory hyperpigmentation, e.g. pigmentation following acne and other inflammatory skin disorders; melasma; and pigmentation following medical and cosmetic procedures. Only products containing hydroquinone are approved by the US FDA for the treatment of hyperpigmentation. Hydroquinone, developed in the 1950s, is restricted or banned in Europe and in many Asian countries due to irritancy and other safety concerns. New effective and safe treatments are greatly needed.