STOCKHOLM, Aug. 11, 2020 /PRNewswire/ -- The Primary endpoint was met in the Phase 3 study
TWELVE MONTH PERIOD (JUL 2019-JUN 2020)
Comparative figures for the period refer to January 2019 - June 2019 (Note: 12 months vs. 6 months due to shortened fiscal year)'
FOURTH QUARTER (APR-JUN 2020)
Comparative figures for the fourth quarter refer to April 2019 - June 2019
* All comparative figures refer to continuing operations
SIGNIFICANT EVENTS IN THE FOURTH QUARTER (APR-JUN 2020)
SIGNIFICANT EVENTS AFTER THE END OF THE FOURTH QUARTER
STATEMENT FROM THE CEO
In June, the results were presented from the second of two clinical studies in the Phase 3 program for MOB-015. As in the North American study, the European study met the primary endpoint and no serious adverse effects were identified. The superior mycological cure rate for MOB-015 has now been confirmed in two pivotal studies, strengthening our conviction that MOB-015 has the potential to become the future market leader in onychomycosis. We now look forward to finding the best path to approval in dialogue with our partners and regulatory agencies.
The European study was conducted at sites in Germany, the UK and Poland and included 452 patients with mild to moderate distal subungual onychomycosis (DSO) affecting 20-60 percent of the great toenail. Patients were randomized to daily treatment for 48 weeks, either with MOB-015 or 8 percent ciclopirox, the most widely used topical drug for onychomycosis.
Mycological cure was achieved in 84 percent of patients, which is unprecedented for a topical treatment and even higher than reported for oral treatments. The pattern is consistent with the results from the North American Phase 3 study, with a low complete cure rate despite the high mycological cure rate. The primary endpoint was met in the EU study as MOB-015 showed non-inferiority versus ciclopirox in achieving a complete cure at 52 weeks. The study results validate the previously presented conclusions: i) MOB-015 delivers a very high mycological cure rate, comparing favorably to oral antifungal drugs with the advantage of earlier onset of action; and ii) the vehicle enables efficient terbinafine delivery but also causes transient whitening/discoloration in nails, which contributes to the low complete cure rate reported.
With the primary endpoint achieved in both the North American study and the European study, the two studies can serve as a basis for product registration in Europe. For market approval in the U.S., the FDA normally requires two studies that show superiority (statistically superior to the comparator) for the primary endpoint. Consequently, an additional study is likely needed for U.S. registration.
This is an unusual situation that requires further dialogue with regulatory agencies and partners, since the outcomes of clinical studies normally are more uniform. In this case, the results for the two main parameters - complete cure and mycological cure - are fundamentally different. The very high mycological cure (ability to kill the fungus) is unprecedented but does not lead to a high complete cure rate, probably due to the observed transient whitening and discoloration of the nail, which complicates the assessment of clinical and complete cure. All experts engaged by Moberg Pharma agree that the high antifungal effect is extremely compelling, and that the product should over time be able to achieve a high rate of complete cure. We are therefore now discussing next steps for MOB-015 with our partners and regulatory agencies.
Anna Ljung, CEO of Moberg Pharma
CONFERENCE CALL - August 11, 2020 at 3:00 p.m. CET
CEO Anna Ljung will present the report at a telephone conference on August 11, 2020, at 3:00 p.m. CET.
Dial-in: SE: +46-8-505-583-50, US: +1-833-526-8382
ABOUT THIS INFORMATION
This information is information that Moberg Pharma AB is obliged to make public persuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 8.00 a.m. CET on August 11th, 2020
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The following files are available for download:
Interim report April â€" June 2020
SOURCE Moberg Pharma