WOMEN’S HEALTH

Recurrent Vulvovaginal Candidiasis (RVVC)

Recurrent vulvovaginal candidiasis (RVVC), more commonly referred to as chronic yeast infection, is a debilitating condition that affects millions of women each year. The physical symptoms of RVVC, such as vaginal itching, burning, irritation, soreness and inflammation, can be painful and distressing. Some women may also experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain.

Although the physical symptoms can be distressing, it is often the emotional and psychological consequences of these recurrent infections that affect sufferers the most. RVVC often impacts the quality of life for women to a degree comparable to asthma, and worse than migraines. Yet despite its impact and high prevalence, there are currently no approved treatment options in the United States.

With no drug approved by the FDA in the U.S. for the treatment of RVVC, the current standard of care is the oral drug fluconazole, which is effective when treated for six months, but infections typically return. In addition, there are safety concerns that limit chronic dosing, including liver toxicity, miscarriage, drug/drug interactions, rare cases of QT prolongation and Torsades de pointes.

Mycovia is developing an oral therapy VT-1161 for the treatment of RVVC. In recently completed Phase 2b clinical studies in patients diagnosed with RVVC, it was shown to have the potential to be a safe and effective oral treatment. Phase 3 studies are currently underway.

Click here to learn more about the clinical trial of VT-1161 in RVVC and other important indications.

 

FUNGAL INFECTIONS

Onychomycosis

A fungal infection that involves the nail as well as the skin under and around the nail, onychomycosis affects approximately 35 million individuals in the United States and millions more around the globe. The prevalence of onychomycosis increases with age, with approximately 18% of individuals over the age of 60 affected. The infection typically involves one or more toenails, although fingernail infections represent about 5% of cases.  

Onychomycosis is a chronic condition, often developing over a period of months or even years. The infected nail can become discolored, thickened and disfigured, and may result in pain when walking. Onychomycosis can also be a significant medical issue for diabetics or other patients with compromised immune systems. In these patients, the infected nail can serve as an entry point for bacterial infection, which can lead to serious complications such as amputation. 

Onychomycosis will rarely improve without medical treatment. Due to concerns about possible side effects, limited efficacy and frequent relapse experienced with current therapies, physicians may discourage some patients from undergoing currently available treatments, which include both oral and topical therapies.

Mycovia has studied oral VT-1161 for the treatment of onychomycosis. This investigational agent has successfully completed a Phase 2b clinical study in patients diagnosed with onychomycosis of the large toenail. 

Additionally, Mycovia’s oral drug candidate VT-1598 has shown results against a range of resistant fungal pathogens:

Candida auris
According to the Centers for Disease Control and Prevention (CDC), Candida auris (C. auris) is an emerging fungal pathogen that presents a serious global health threat. It’s often resistant to many antifungal drugs and it can be difficult to identify with standard laboratory tests. C. auris can cause severe infections in some patients and has caused outbreaks in hospital and nursing home settings. According to the CDC, C. auris infections have been reported in over 30 countries including the United States.

Cryptococcus neoformans (C. neoformans or C. gatti)
Although most people never get sick from breathing in the microscopic fungus in the environment called Cryptococcus neoformans, this fungus can infect people with weakened immune systems. Cryptococcosis can affect the lungs, causing pneumonia-like symptoms, but it can also affect the central nervous system and other parts of the body. When Cryptococcosis spreads to the brain, it can cause cryptococcal meningitis causing headache, fever and neck pain.

Coccidioides
Coccidioides is a fungus that causes a condition called Valley Fever. The fungus is found in soil, and although rare, inhalation can infect people with compromised immune systems. Valley Fever is usually an infection in the lungs, but it can spread to other parts of the body in severe cases, requiring antifungal medication. Symptoms of Valley Fever are usually flu-like such as fever, cough and headache, but in severe cases a rash may appear.