Policy & Regulation
Moberg Pharma announces expert evaluation clarification on phase 3 results providing strong support for MOB-015
23 January 2020 -

Swedish pharmaceutical company Moberg Pharma AB (STO:MOB) announced on Wednesday the completion of an expert evaluation of the results from its North American phase 3-study.

Reportedly, the analysis conducted with key opinion leaders (KOLs) has confirmed the validity of the data presented in December 2019 and increased the understanding of the study outcomes.

Key conclusions include that MOB-015 delivers a very high mycological cure rate that compares favourably to oral antifungal drugs, with the added advantage of an earlier onset of action; confirmation that the proprietary vehicle technology increases the hydration and permeability of the nail plate enabling efficient terbinafine delivery, however it also confounds the assessment of clinical cure and complete cure; and that a likely solution to the problem is a shorter dosing regimen with the potential to deliver superior complete cure rates.

In December 2019, the topline results were presented from the first of two clinical studies in the phase 3 programme for MOB-015, meeting the primary endpoint. Mycological cure (eradicating the fungal infection) was achieved in 70% of the patients, which is substantially higher than reported for other topical treatments (30% to 54%). In addition, 83% of the patients reported visible nail improvement by the first follow-up visit. However, despite the strong mycological cure and rapid visible improvement, a lower than expected complete cure rate of 4.5% (normal looking nails and negative fungal culture) was reached, which was surprising because a high mycological cure is typically followed by clinical cure and the combined endpoint complete cure.

Moberg Pharma has since engaged leading key opinion leaders to help the company verify the results and better understand the reasons for the conflicting outcome. The key question for the KOLs has been to help the company understand why the high mycological cure did not result in high complete cure.

A solution to the problem was identified in collaboration with the KOLs. After analysis of the available clinical data, including data from the recent phase 3 study, earlier Moberg Pharma studies as well as from the literature, the KOLs, as well as company experts, concluded that the complete cure rate for MOB-015 likely can be increased substantially by a shorter treatment period followed by a maintenance period.