Moberg Pharma (MOB) Study Update summary

Study design and methodology

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

• Dosing regimen was eight weeks of daily application 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.

• Mycological cure and clinical cure were key endpoints, with comprehensive training and consistent trial elements to ensure compliance.

Key results and efficacy outcomes

• Primary endpoint (complete cure at 52 weeks) was not met; only 1.5% of patients achieved complete cure with MOB-015, none in vehicle group.

• Mycological cure rate was 25% for MOB-015, lower than previous studies (which reached up to 76%).

• Treatment success (mycological cure and almost/completely clear nail) was 11.2% for MOB-015; nail whitening was reduced compared to earlier studies.

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

• Lower mycological cure attributed to insufficient duration of daily dosing; weekly maintenance prevented reinfection but did not eradicate fungus.

Strategic and regulatory implications

• Study results do not support U.S. regulatory filing; FDA requires two successful superiority studies.

• No immediate plans for another U.S. study due to cost and timeline; focus shifts to Europe where approvals and higher efficacy are established.

• Bayer will halt the upcoming launch and terminate the EU license agreement, returning full EU rights and milestone payments to Moberg Pharma.

• Patent protection remains until 2032; new data needed for further patent applications.