- Presentations expand VIVJOA safety profile
and prescribing information
in hepatic and renally impaired
patients
DURHAM,
N.C., Aug. 1, 2024 /PRNewswire/ -- Mycovia
Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical
company, has announced that it will present topline results from
three Phase 1 studies evaluating VIVJOA® (oteseconazole) at
the 2024 Infectious Diseases Society for Obstetrics and Gynecology
(IDSOG) Annual Meeting, in Portland,
Oregon, August 1-3. VIVJOA is
the first FDA-approved medication for recurrent vulvovaginal
candidiasis (RVVC), or chronic yeast infection, in post-menopausal
women or women who are not of reproductive potential.
The 2024 IDSOG Annual Meeting will gather healthcare
professionals to discuss research and innovation in the
epidemiology, pathophysiology, prevention, management and impact of
infectious diseases in women.
"We are proud to return to the IDSOG Annual Meeting this year to
discuss these insightful studies of VIVJOA," said Dr. Stephen Brand, Chief Development Officer at
Mycovia Pharmaceuticals. "With VIVJOA now available in the U.S., we
are grateful for this platform to share the growing body of safety
data evaluating VIVJOA in women with chronic yeast infection."
During Poster Session 1 on Thursday,
August 1, from 3:30 to 4:30 p.m.
PST, Dr. Brand will present: Pharmacokinetic and Safety
Results From Two Phase 1 Studies of VIVJOA in Women With Severe
Renal Insufficiency Not Requiring Dialysis vs Normal Renal Function
and Women With Moderate Hepatic Impairment vs Normal Hepatic
Function.
During Oral Abstract Session 6 on Saturday August 3, from 11:00 a.m. to 12:30 p.m., Dr. Brand will present:
Single-Center, Randomized, Double-Blind, Placebo- and
Active-Controlled, Parallel, Nested Crossover, Thorough QT Study of
VIVJOA in Healthy Women.
Among drug-specific characteristics of antifungal agents, renal
disposition and nephrotoxicity are important clinical
considerations, as many patients requiring antifungal therapy have
compromised organ functions or are receiving other potentially
nephrotoxic or hepatotoxic medications.
VIVJOA data presented will include safety and tolerability in
women with mild to severe renal insufficiency, as well as in women
with mild and moderate hepatic impairment, pharmacokinetic
parameters, and cardiac repolarization, further characterizing
VIVJOA's use in women treated for RVVC.
These new findings are reflected in the recently revised
prescribing information.
"The data from these studies are critical to further advance our
understanding of VIVJOA's utility for RVVC, in particular in a
subset of women who are at higher risk for kidney, liver or cardiac
issues," said Dr. Thorsten
Degenhardt, Chief Operating Officer. "We hope our
presentations will help healthcare professionals in conversations
with their RVVC patients who are appropriate for our
medication."
About Recurrent Vulvovaginal Candidiasis
RVVC is a debilitating, chronic infectious condition that
affects 138 million women worldwide each year. RVVC, also known as
chronic yeast infection, is a distinct condition from vulvovaginal
candidiasis and defined by the Centers for Disease Control and
Prevention as three or more symptomatic acute episodes of yeast
infection in 12 months. Primary symptoms include vaginal itching,
burning, irritation and inflammation. Some women may experience
abnormal vaginal discharge and painful sexual intercourse or
urination, causing variable but often severe discomfort and
pain.
About VIVJOA®
VIVJOA® (oteseconazole) is an azole antifungal indicated to
reduce the incidence of recurrent vulvovaginal candidiasis (RVVC)
in females with a history of RVVC who are not of reproductive
potential. VIVJOA is the first FDA-approved medication that
provides sustained efficacy demonstrated by significant long-term
reduction of RVVC recurrence through 50 weeks versus comparators.
Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall
integrity, and this selective interaction is also toxic to fungi,
resulting in the inhibition of fungal growth. Due to its chemical
structure, oteseconazole has a lower affinity for human CYP enzymes
as compared to fungal CYP enzymes. The FDA approved VIVJOA based
upon the positive results from three phase 3 clinical trials of
oteseconazole – two global VIOLET studies and one U.S.-focused
ultraVIOLET study, including 875 patients at 232 sites across 11
countries.
Please click here for full Prescribing Information.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
VIVJOA is contraindicated in females of reproductive potential.
Females who are NOT of reproductive potential are defined as:
persons who are biological females who are postmenopausal or have
another reason for permanent infertility (e.g., tubal ligation,
hysterectomy, salpingo-oophorectomy).
VIVJOA is contraindicated in pregnant and lactating women.
VIVJOA is contraindicated in patients with known
hypersensitivity to oteseconazole.
WARNINGS AND PRECAUTIONS
Based on animal studies, VIVJOA may cause fetal harm. The drug
exposure window of approximately 690 days (based on 5 times the
half-life of oteseconazole) precludes adequate mitigation of the
embryofetal toxicity risks. Advise patients that VIVJOA is
contraindicated in females of reproductive potential, and in
pregnant and lactating women because of potential risks to a fetus
or breastfed infant.
ADVERSE REACTIONS
The most frequently reported adverse reactions among
VIVJOA-treated patients in clinical studies included headache
(7.4%) and nausea (3.6%).
DRUG INTERACTIONS
VIVJOA is a Breast Cancer Resistance Protein (BCRP) inhibitor.
Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin)
may increase the exposure of BCRP substrates, which may increase
the risk of adverse reactions associated with these drugs.
Please see full Prescribing Information and Patient
Information.
To report SUSPECTED ADVERSE REACTIONS, contact Mycovia
Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
About Mycovia Pharmaceuticals, Inc.
Mycovia Pharmaceuticals, Inc. is an emerging biopharmaceutical
company dedicated to recognizing and empowering those living with
unmet medical needs by developing novel therapies. VIVJOA®
(oteseconazole) capsules, the first FDA-approved product for
Mycovia, is an azole antifungal indicated to reduce the incidence
of recurrent vulvovaginal candidiasis (RVVC) in females with a
history of RVVC who are not of reproductive potential.
Oteseconazole received FDA Qualified Infectious Disease Product and
Fast-Track designations to become the first FDA-approved therapy
for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu
Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize
oteseconazole in China, including
mainland China, Hong Kong, Macau and Taiwan.
Mycovia also recognizes a tremendous potential for its oral
fungal inhibitors and a growing need to treat a range of multi-drug
resistant fungal pathogens. For more information, please visit
www.mycovia.com.
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SOURCE Mycovia Pharmaceuticals, Inc.