Moberg Pharma has reported successful top-line results from a Phase II trial of MOB-015 to treat patients with onychomycosis (nail fungus).

A total of 25 patients were included in the open-label clinical trial, which was carried out at Sahlgrenska University Hospital, Sweden, with professor Jan Faergemann as the coordinating investigator.

In the trial, patients with onychomycosis affecting 25% to 75% of at least one great toe nail received treatment with MOB-015 during 12 months and were followed for a total of 15 months.

Results showed that of the 24 patients who completed the trial, 13 met the primary endpoint of mycological cure after 15 months, while the secondary endpoint, mycological cure and excellent clinical improvement or cure was observed in seven of 24 patients.

The company said that biopsies confirmed high levels of terbinafine in the nail plate and nail bed, while MOB015 seen to be well-tolerated in trial.

Sahlgrenska University Hospital Dermatology Unit Dr Jan Faergemann said: “The mycological cure rate and clinical outcome in the study are remarkable for a topical treatment.

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“These results are promising for future phase III studies.”

“Especially since the majority of these patients had more than 50% nail involvement at inclusion. These results are promising for future phase III studies. An efficacious and safe topical terbinafine product would be highly attractive for dermatologists worldwide.”

MOB-015 is a proprietary topical formulation of Moberg Pharma-developed terbinafine, which is currently the most widely used oral prescription treatment for onychomycosis.

According to the company, preclinical and clinical data confirm that MOB-015 delivers effective levels of terbinafine through the nail and into the nail bed.

Moberg Pharma CEO Peter Wolpert said: “The excellent phase II results exceeded our expectations. MOB-015 has the potential to become a superior and leading product in the large and growing onychomycosis market.

“We are now proceeding with partner discussions for further development and commercialisation of MOB-015.”

Image: A toenail affected by onychomycosis. Photo: courtesy of Grook Da Oger.