Moberg Pharma AB called a late stage clinical trial a success after the nail fungus treatment MOB-015 cured the condition and removed the fungus, meeting the main and secondary goals of two studies.
The results, however, appear contradictory, according to the Swedish company. So Moberg provided more detail on the two studies in an updated press release issued Dec. 12.
MOB-015 achieved a cure rate of 4.5% during the clinical trial, compared to 0% in patients who received a placebo, according to a Dec. 9 press release. A cure is defined by Moberg as a completely clear nail and a cure of the fungus itself, called mycological cure. A mycological cure was achieved in 70% of the patients. The therapy also achieved treatment success in 15.4% of patients. A majority of patients reported improvement in their conditions as early as 12 weeks, with 33% reporting their toenails were cured or almost cured.
The therapy was generally well-tolerated, and adverse events were similar to placebo.
Moberg acknowledged that the percentages seen in the trial were contradictory in the Dec. 12 update.
"Since the results are somewhat contradictory and the company has received many questions, we want to clarify the various study parameters as well as our view of the current status and next step," Moberg said.
The company said the discrepancy is in how investigators viewed the visual improvement of the nail. While mycological cure can be tested in the lab, an assessment of the nail's return to a normal appearance is more subjective to the investigators reviewing the data.
"The outcome of the study is surprising, since a high mycological cure is normally over time followed by normalization of the nail's appearance," Moberg said.
Review of the data is continuing after release of the initial topline results. Moberg said all nail photos are being reviewed with experts, and more insight will be gained from an ongoing study in Europe in which MOB-015 is being compared to a commonly used topical treatment for the condition.
"It is too early to draw any firm conclusions from the first study in the Phase 3 program," Moberg said. "The company plans to provide an update once additional information is available."
Shares of Moberg were down more than 18% to 15.84 Swedish krona at the close of the European markets Dec. 12.
As of Dec. 11, US$1 was equivalent to 9.43 Swedish krona.