Manhattan Pharmaceuticals begins phase 2a study on new psoriasis treatment

By E. Janene Geiss

Philadelphia, Dec. 28 - Manhattan Pharmaceuticals, Inc. said Wednesday that a phase 2a study has been initiated with PTH (1-34), its experimental product for the topical treatment of psoriasis.

The double-blinded, placebo-controlled trial, which is being conducted at Boston University Medical Center, will treat 40 adult volunteers up to age 80 with daily application of a placebo and two strengths of PTH (1-34), all delivered in the proprietary Novasome base developed by IGI, Inc., according to a company news release.

The aim of the study is to determine the therapeutic efficacy and safety of PTH (1-34) (a parathyroid hormone-related peptide analog) for the treatment of adult patients with psoriatic lesions, officials said.

The treatment is based on a naturally occurring protein in skin and hair follicles that serves to regulate the growth of skin cells.

When applied to psoriatic lesions in an earlier phase 1/2 clinical trial, officials said, PTH (1-34) restored the normal development and migration of skin cells, preventing cell build-up and the formation of plaques.

Because PTH (1-34) is the active ingredient in a currently approved injectable product for osteoporosis, Manhattan said it expects to be able to seek approval of its topical form of the drug under the provisions of a 505(b)(2) regulatory submission, a form of New Drug Application that relies on the FDA's previous findings in approved NDAs and published literature. This limits new systemic safety data requirements, officials said.

Psoriasis affects nearly 4.5 million Americans, with 15% to 25% of those patients developing a moderate to severe form of the disease. Psoriasis patients seeking treatment in the United States account for nearly 2.4 million dermatology visits a year at a total cost of $3 billion, officials said.

Current topical treatments for psoriasis range from traditional tar salve, which has limited efficacy, to tazarotene gel, which commonly causes localized itching and burning. Topical corticosteroids are a mainstay in the treatment of localized psoriasis, but they are not recommended for long-term use and can have significant side effects and intolerability issues, officials said.

The most widely prescribed non-steroidal compound is a topical form of calcipotriene, which has the brand name Dovonex. It has been owned and promoted by a variety of companies since its introduction in 1994 and currently generates about $140 million in U.S. product sales and significant additional revenue worldwide.

The company said PTH (1-34)'s early data shows a potentially stronger product profile than Dovonex.

Manhattan is a New York City development-stage pharmaceutical company that acquires and develops proprietary prescription drugs for large, underserved patient populations.

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