HL009 (Adenosylcobalamin Liposomal Gel)

HanAll is currently developing HL009, adenosylcobalamin liposomal gel, with three different potential mechanisms of actions. HL009 can bind to nitric oxide (NO) which causes dermatitis; also it can inhibit inducible nitric oxide synthase (iNOS) to further reduce NO levels. From an immunology perspective, HL009 can activate T regulatory cells which excrete IL-10 and TGF-beta suppressing immune response.

Adenosylcobalamin has low permeability through skin due to its large molecular size and relatively high hydrophilicity. Thus, HanAll has formulated adenosylcobalamin topical product utilizing liposomal formulation technology. Benefits of liposomal formulation technology include improved stability, enhanced skin penetration due to increased lipophilicity, and reduced skin irritation by using lipids with proven safety.

Current treatment options for atopic dermatitis are limited especially in pediatric patients as well as affected sites with great sensitivity (i.e. face, etc). Systemic antihistamines are being prescribed, however, their efficacy against atopic dermatitis are relatively weak with lack of evidence. Topically applied corticosteroids are the mainstay of therapy for AD. Most clinicians and patients prefer to use low potency corticosteroids, but significant number of patients require potent corticosteroids which are generally avoided in skin folds and on the face. Since atopic dermatitis most often affects pediatric population, uses of steroids are relatively limited due to various adverse drug events (i.e. skin atrophy, growth dysfunction, etc). The topical calcineurin inhibitors appear to be effective for the treatment of AD, and, unlike topical steroids, do not cause skin atrophy. Therefore, they may be useful on the face, neck, and in skin folds. However, concerns have been raised by the FDA about a possible link to cancers and in 2006 placed a “black box” warning for these agents. Accordingly, there are no safe agents for clinicians and parents to comfortably use in pediatric population for AD. To address above issues, HanAll has formulated adenosylcobalamin which is generally regarded as effective and safe for AD.

HanAll has conducted number of preclinical studies and phase II trials has been completed in Korea and US. HanAll is also preparing phase III trial in Korea. Number of patents also has been filed to various countries.