Apricus Bio's MycoVa demonstrates 'non-inferiority' for treatment of onychomycosis compared to Loceryl

Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) today announced that an additional analysis conducted on behalf of the Company has shown that MycoVa^™ has successfully demonstrated 'non-inferiority' for the treatment of onychomycosis (commonly referred to as nail fungus), compared to the current standard of care in Europe for topical therapy, Loceryl^®.

'Non-inferiority' means that the experimental treatment worked well enough, compared to the effective existing drug, to support the conclusion that the new test drug is also effective. With this new analysis, Apricus Bio intends to request regulatory guidance from certain European agencies for the continued development of MycoVa^™ and hopes to eventually file for approval in certain European countries to market the drug for onychomycosis. "We are very pleased with this new analysis," says Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "We believe it may allow us to move forward towards eventual approval of the drug."

MycoVa^™(formally known as NM100060) combines an existing, approved drug for nail fungus, terbinafine, with Apricus' NexACT^® technology that enhances the absorption of the drug through the skin. Clinical trials on the drug started after 2005, when NexMed (now known as Apricus Bio) signed an agreement with Novartis, under which Novartis assumed responsibility to develop and commercialize the drug.

The first clinical trials did not show clear-cut efficacy, and in 2008, NexMed announced that the results were not strong enough to support filing for new drug approval with the U.S. Food & Drug Administration. Novartis declined to continue to develop the drug in 2009, and NexMed acquired the worldwide rights to the drug, subject to certain payments to be made to Novartis.

A later trial conducted by Novartis in Europe between 2007 and 2009, comparing MycoVa^™ with Loceryl^® over 48 weeks, was more promising. The reanalysis of the comparator trial data announced today shows that MycoVa^™ is no less effective than Loceryl^®in curing nail fungus. The percentage of patients with an adverse event that was suspected to be related to study drug was low for both drugs with no serious adverse events attributed to the drugs. There also were no safety concerns.

"We were disappointed that Novartis did not move forward with the drug in 2009, but we were excited when we regained worldwide rights, subject to certain payments to Novartis," explained Dr. Damaj. "We were convinced at that time, and remain so today, that MycoVa^™ had, and has, the potential to treat patients with mild onychomycosis. The analysis that we have recently performed has convinced us to move forward and request regulatory guidance meetings from health agencies in the United Kingdom, the Netherlands and Germany."

In the study, 1,029 patients with mild to moderate nail fungus were given either MycoVa^™ (a topical 10% terbinafine hydrogen chloride formulation) or Loceryl^® (5% amorolfine nail lacquer) for 48 weeks of treatment. The primary objective endpoint was a complete cure. The secondary endpoints were killing the fungus and improving the appearance of the nail.

The reanalysis of the results showed no significant difference in either the primary or secondary endpoints between MycoVa^™ and Loceryl^®,which is a registered trademark of Galderma.

The advantage of Apricus Bio's MycoVa^™ is that it is easy to apply, thus improving patient compliance.  MycoVa^™ is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug to penetrate through the nail plate to the nail bed and surrounding area where fungus is located.  By contrast, Loceryl^® requires more patient care before applying the lacquer. For Loceryl^®, this includes filing the affected areas of nail, including the nail surfaces, as thoroughly as possible. The surface of the nail should then be cleansed using disposable swabs.  The nail lacquer should be applied onto the entire surface of the infected nail(s) using reusable applicators.  Before repeat application of Loceryl^®, the affected nails should be filed down again as required, following cleansing with a cleaning pad to remove any residual lacquer. 

Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. According to the Merck Manual, the worldwide incidence rate of onychomycosis is approximately 10%. As described by Iorizzo and Piraccini (2007), the incidence has been increasing due to diabetes, immunosuppression and an aging population. While occurring in approximately 2.6% of children younger than 18 years, it occurs in as much as 90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma has stated that the worldwide market is approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.