Malin Corporation PLC Mycovia Reports Positive Topline Results (1324I)
10 December 2020 - 4:00AM
UK Regulatory
TIDM0Y71
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
For further information please contact:
Malin
Jessica Bergin, Investor Relations & External Reporting
Tel: +353 (0)1 901 5700
investorrelations@malinplc.com
Davy Corporate Finance (Euronext Growth Adviser & Joint
Broker)
Brian Garrahy / Daragh O'Reilly
Tel: +353 1 679 6363
Liberum (Joint Broker)
Bidhi Bhoma / Euan Brown
Tel: +44 (0) 20 3100 2000
Powerscourt (Irish Media enquiries)
Eavan Gannon
Tel: +353 87 236 5973
malin@powerscourt-group.com
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END
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