Malin Corporation PLC Mycovia Reports Positive Topline Results (1324I)

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RNS Number : 1324I

Malin Corporation PLC

09 December 2020

Malin Corporation plc

Viamet's successor, Mycovia, reports Positive Topline Results from Phase 3 VIOLET Studies of Oteseconazole in Patients with RVVC

   --    Primary and secondary efficacy endpoints met 
   --    Drug was safe and well-tolerated 
   --    NDA submission and US launch planned for 2021 

Dublin-Ireland, 9 December 2020 : Malin Corporation plc. (Euronext Growth Dublin:MLC) (Malin), a company investing in highly innovative life sciences companies, is pleased to note that Mycovia Pharmaceuticals (Mycovia), a company in which Malin's investee company, Viamet Pharmaceuticals (Viamet), has a significant economic interest, has announced positive topline results from its two pivotal Phase 3 VIOLET clinical trials for oteseconazole, its drug candidate for treating patients with recurrent vulvovaginal candidiasis (RVVC).

Topline data shows that Mycovia's pivotal Phase 3 VIOLET studies' primary and secondary efficacy endpoints successfully met statistical significance through Week 48. Mycovia also announced that it expects to have topline data from its third Phase 3 trial, an ultraVIOLET clinical trial evaluating the clinical effectiveness of oteseconazole compared to fluconazole, by year end. Data from all three clinical studies will be submitted as part of Mycovia's planned NDA submission in the first half of 2021 with an expected US launch in 2021. RVVC, commonly known as chronic yeast infection, is a debilitating infectious condition that affects nearly 138 million women worldwide each year and is defined as three or more episodes in a year.

"We are delighted with the Phase 3 data announced by Mycovia today. These data present the promise of a safe and effective therapy for women suffering from this chronic infection where there is currently no FDA approved therapy," said Darragh Lyons, Malin Chief Executive Officer. "We look forward to the final Phase 3 data and submission of a NDA over the coming months which will hopefully trigger the initiation of economic returns to Viamet shareholders, including Malin."

Malin owns approximately 15% of Viamet and carried its investment in Viamet at an estimated fair value of EUR80.1 million at 30 June 2020 under International Private Equity and Venture Capital Valuation guidelines.

A copy of Mycovia's press release is available to view here .

ENDS

About Malin Corporation plc

Malin (Euronext Growth Dublin:MLC) is a company investing in highly innovative life sciences companies. Its purpose is to create shareholder value through the application of long-term capital and operational and strategic expertise to a diverse range of global healthcare businesses. Malin has a focus on innovative businesses underpinned by exceptional science and works with its investee companies, providing strategic and financial support to enable them to reach their value potential. Malin is headquartered and domiciled in Ireland and listed on the Euronext Growth Dublin. For more information visit www.malinplc.com

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December 09, 2020 12:00 ET (17:00 GMT)