Date: 2013-03-11
Type of information:
phase: 2
Announcement: discontinuation of the study
Company: Moberg Derma (Sweden)
Product: Limtop® (imiquimod)
Action mechanism: Limtop® is based on a patent-pending formulation of imiquimod, a proven compound, which results in an optimal dose of the active substance being delivered into the skin. The compan's preclinical results show that Limtop has a significantly better capacity than existing preparations to transport the active substance to the target tissue in the skin.
Disease: actinic keratinosis
Therapeutic area: Dermatological diseases
Country: Germany
Trial details:
Latest
news: * On March 11, 2013, Moberg Derma has announced that the company has decided to discontinue the development of Limtop® - a drug candidate for the treatment of actinic keratosis. The decision is based on data from a completed phase II clinical trial, where the efficacy of Limtop® did not reach the predefined target. "Based on data from the completed study, we deem that the project's commercial potential has decreased and that continued investment therefore is not justified. This does not affect the company's assessment for continued profitable growth during 2013," said Peter Wolpert, President and CEO of Moberg Derma AB.
* On September 6, 2012, Moberg Derma has announced that it has successfully completed the recruitment of 97 patients with actinic keratosis (AK) on the head or face for the on-going Limtop phase II study. The aim is to evaluate the efficacy and safety of three different dose regimens of Limtop. The results are expected in the first half of 2013. Limtop is an innovative formulation of imiquimod for the treatment of actinic keratosis, genital warts and basal cell cancer. The objective is a product with short treatment duration, improved safety profile and similar or better efficacy than that of competing preparations.
* On May 2, 2012, Moberg Derma has announced that the German Federal Institute for Drugs and Medical Devices (BfArM) has granted Moberg Derma approval to initiate a clinical phase II trial for Limtop®. The aim is to evaluate the efficacy and safety of three different dose regimens of Limtop in a study involving 96 patients with Actinic Keratosis (AK) on the head or face. The results are expected in the first half of 2013.
The approval was granted following positive results from a phase I study on 30 healthy volunteers who were treated daily for 21 days. No serious treatment-related adverse events were observed.
