Moberg Pharma Reveals Phase 3 Data, Reclaims EU Rights to MOB-015

In a recent update, Moberg Pharma announced the outcomes of its North American Phase 3 study on the topical onychomycosis treatment, MOB-015. This study, involving 384 patients across 33 centers in the US and Canada, aimed to explore whether a reduced treatment regimen could maintain efficacy. Patients were divided into two groups: 260 received MOB-015, while 124 were given a vehicle as a control. Unlike previous European trials, which involved daily application of the drug, this study tested an eight-week daily dosing followed by weekly maintenance for 40 weeks. Unfortunately, the study's primary endpoint—complete cure of the target toenail—was not met.

The North American trial was expected to bolster the treatment's competitive edge by potentially reducing the frequency of application after the initial phase. However, results indicated that the shortened daily dosing period was insufficient compared to the more rigorous schedule approved in the European Union. In light of these findings and strategic considerations, Bayer Consumer Health decided to halt the scheduled launch of MOB-015 in North America. Consequently, Bayer and Moberg Pharma intend to terminate their licensing agreement, allowing Moberg Pharma to regain full rights to MOB-015 in the EU while retaining previously paid milestone payments.

Despite the North American setback, Moberg Pharma remains optimistic about MOB-015's market potential. The product has already seen success in Sweden under the brand name Terclara®, capturing a 44% market share and demonstrating a 76% mycological cure rate with daily application. This performance underscores the product's strength and marketability, suggesting that the marketing strategy resonates well with consumers.

Moberg Pharma's future strategy involves a focus on direct sales in the US alongside strategic partnerships in other key markets. However, based on the latest data, the company is reevaluating its US strategy and shifting its focus toward Europe, where greater growth opportunities exist. Moberg Pharma aims to enhance its presence in Europe by playing a more active role in commercialization and brand ownership, which could lead to a larger share of the value chain. The company is currently in discussions with potential European partners to chart the best path forward.

Anna Ljung, CEO of Moberg Pharma AB, expressed that while the North American results introduced new challenges, they also highlighted the superior efficacy of the daily regimen approved in Sweden. This situation presents an opportunity for the company to strengthen its presence in the EU market and capture more value for the product.

In the North American study, complete cure was achieved in only 1.5% of patients using MOB-015, with no cures in the control group. Mycological cure was significantly better at 25.0% for those on active treatment. Treatment success, which includes mycological cure and a nearly clear nail, was achieved in 11.2% of patients. Importantly, MOB-015 was generally well tolerated, with no major safety issues or serious adverse events reported.

MOB-015, a topical formulation of terbinafine, offers a promising alternative to oral terbinafine, the current standard for onychomycosis treatment, which can cause systemic side effects. The drug has been approved for use in 13 countries, supported by earlier Phase 3 trials demonstrating high efficacy and safety. Moberg Pharma is committed to advancing its commercialization efforts and exploiting opportunities within the European market to maximize the potential of MOB-015.