Moberg Pharma (MOB) Study Update summary

Study design and methodology

• North American phase III study enrolled 384 patients at 33 centers in the U.S. and Canada, with two-thirds receiving MOB-015 and one-third receiving vehicle.

• Dosing regimen was eight weeks of daily dosing followed by 40 weeks of weekly maintenance, differing from previous studies with continuous daily dosing.

• Study aimed to reduce nail whitening and overhydration seen in prior trials by adjusting dosing frequency.

• Key elements such as investigators, CRO, and mycology lab were kept consistent with previous studies.

• Biopsies at 24 weeks showed high terbinafine concentration in the nail bed with daily treatment.

Key efficacy and safety results

• Primary endpoint (complete cure at 52 weeks) was achieved by 1.5% of MOB-015 patients and 0% of vehicle group; this was not statistically significant.

• Mycological cure was 25% for MOB-015 at 52 weeks (p=0.030), lower than previous studies (up to 76%).

• Treatment success (mycological cure and almost/completely clear nail) was 11.2% for MOB-015 (p=0.003).

• MOB-015 was generally well tolerated with no serious adverse events related to the drug.

• Nail whitening was reduced compared to earlier studies, with fewer patients developing whitening at 12 weeks.

Strategic and regulatory implications

• Study did not meet the primary endpoint, so the data package is insufficient for U.S. regulatory approval; FDA requires two successful superiority studies.

• Bayer will halt the upcoming launch of MOB-015 and intends to terminate the EU license agreement, returning full EU rights to Moberg Pharma.

• Moberg Pharma will focus on the EU market, leveraging the effective daily dosing regimen already approved in 13 countries.

• OTC route in the U.S. is being considered but would require significant time and investment.

• Patent protection is granted until 2032; new data needed for ongoing patent applications based on lower dosing.