Fungal Infection is a major cause of morbidity worldwide. Fungal Infections are caused by different fungi found in environment. Although, some fungi are not dangerous at all but few types of fungi are harmful to health. It involves the invasion of tissue such as skin and lung by specific type of fungi. According to Centers for Disease Control and Prevention (CDC), a public health institute in the U.S., approximately 1.5 million different species of fungi are present on earth. Out of them, 300 fungi species cause fungal infection in humans. Fungal Infection Trust, a U.K. based organization for the improvement of quality of life of fungal infected patient observed that approximately billion people are affected by fungal infection every year. It is most common among people who are using antineoplastic agents, immunosuppressive agents, broad-spectrum antibiotics and prosthetic devices. Patients with HIV infection, burns, neutropenia and pancreatitis are at high risk of developing fungal infection.
The fungal infection pipeline has more than 60 drugs. In pipeline analysis, drugs are analyzed based on route of administration and molecule type. The pipeline is also analyzed on the basis of monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and Pre-clinical stage.
Phase III & Filed
Phase III clinical trial known for the comparison of new treatments with the standard treatment in which the safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. After the completion of Phase III stage, the company filed New Drug Application to the regulatory authorities known as filed stage. There are 3 drugs for fungal infection in Phase III clinical trial. Terbinafine, also known as MOB-015, is a drug candidate of Moberg Pharma AB. The drug candidate is being developed for the treatment of onychomycosis. In fungal infection, no drugs have been registered for NDA filing.
VT-1161, a phase II drug candidate of Viamet Pharmaceuticals, Inc. for the treatment of onychomycosis (Fungal Infection) and recurrent vulvovaginal candidiasis. Phase II clinical trial is the second phase that answer safety, efficacy and dosing of the new intervention. There are total 14 drugs present in phase II trial of fungal infections. Phase II clinical trial take around 2 years to complete and between 100 – 120 patients participate in the Phase II trial.
PC945 is under development by Pulmocide Ltd. for the prevention and treatment for aspergillosis in cystic fibrosis, lung transplant and allergic bronchopulmonary aspergillosis. The drug candidate targets the cytochrome P450 C-14 alpha demethylase (CYP51) and inhibits its action. There are 8 drugs present in Phase I clinical stage. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.
VB 2862 is a pre-clinical drug candidate of Vyom Biosciences for the treatment of recalcitrant tinea infections. The company is using molecular replacement therapy platform for the development of VB 2862. Preclinical study is also known as animal study. It is done before testing a drug in people to find out the toxicity profile of the drug. Preclinical study is of two types, including in vitro and in vivo.
Pipeline analysis provides description about the key companies developing fungal infections drugs. Some of the key players actively involved in the research and development are Moberg Pharma AB, Viamet Pharmaceuticals, Inc., Pulmocide Ltd., Vyom Biosciences, NovaDigm Therapeutics Inc., Matinas BioPharma Holdings Inc., Sol-Gel Technologies Ltd. and Eisai Co. Ltd.