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Research and Development
Research and Development
Cervical cancer is caused by long-term infection of the basal cells of the cervix by 14 different subtypes of human papillomavirus (HPV), including HPV types 16, 18, 31, 33, 35, 45, 52, and 58. Persistent HPV infection leads to cervical dysplasia (cervical intraepithelial neoplasia), which often takes more than 10 years to progress to cervical cancer. Cervical intraepithelial neoplasia (CIN) is classified as CIN1 to CIN3 depending on the extent of the disease, and while partial resection is recommended for more advanced stages of CIN, there is no treatment for mild to moderate cases, leaving patients with no choice but to be followed.In January 2019, the WHO Executive Board identified accelerating the elimination of cervical cancer as a global public health problem. Approximately 30 million and 10 million women worldwide have CIN1/2 and CIN3, respectively. Of these, half a million women will develop cervical cancer and more than a quarter of a million will die each year. We recognize that the current situation is a serious problem for many women with CIN.
There are currently no drugs approved for the treatment of cervical intraepithelial neoplasia (CIN). HPV vaccines (Gardasil and other products) have been approved for administration to young women and men before they become sexually active to prevent HPV infection. The two main management approaches for CIN are observation (with HPV testing, cervical smear and/or ?οlрο?соpy) or treatment with excision or ablation of the abnormal tissue in the cervix (the cervical transformation zone) while preserving the uterus. The former is for patients with CIN1 and some patients with CIN2. The latter is for patients with CIN2 or higher.
Our drug candidate is a vaginal tablet designed to act directly on the cervix. It is intended to be self-administered by CIN patients at a stage prior to surgery for CIN and is expected to suppress HPV replication in the infected area and repair dysplastic tissue. The aim is to prevent the development of cervical cancer. Clinical trials have already begun in Japan and South Korea and, in addition to a high level of safety, the efficacy of tissue repair has been observed after 28 days of treatment in patients diagnosed with CIN2 and who have been found to have 'abnormal' cervical cells by cytology immediately prior to treatment. We believe that there is both medical and societal value in seeking to establish a therapeutic drug for CIN, for which there has been no treatment other than surgery.
Our therapeutic is patented and has been approved in Japan, Europe, China, Taiwan and South Africa and is under review for approval in other countries such as the United States.
Warts are caused by infection with the human papilloma virus (HPV). HPV enters the skin through small scars and causes infection of the skin's keratinocytes. The infected keratinocyte divides at a faster rate, causing thickening of the epidermis in the infected area and the formation of warts. Typical warts that appear on the hand, foot or face are called common warts and are caused by human papilloma virus types 2, 27 and 57. Although warts can affect people of all ages, children are particularly susceptible and may develop numerous warts.
The main treatment is cryosurgery using liquid nitrogen, which can cause pain and blisters. As it is difficult to eliminate the virus completely, a long period of treatment may be required. There is no effective antiviral medication.
Our drug candidate is an ointment that acts directly on common warts and is designed to inhibit the proliferation of HPV and repair wart tissue. Clinical trials have already begun in Japan, and it has been confirmed that the drug is highly safe and effective in reducing the size of warts and completely regressing them after 84 days of twice-daily administration. We have partnered with Iwaki Pharmaceutical Co., Ltd. for the development and commercialization of this drug in Japan. We aim to obtain regulatory approval for this product as a prescription medicine that can be used for pain-free treatment compared with treatments that use liquid nitrogen to destroy affected tissue.
Our treatment is patented and has already been granted in Japan, and examination is scheduled to begin in the United States and other countries around the world.
Condyloma acuminatum is a flat, dome-shaped, cauliflower-shaped, or pedunculated wart that develops around the genital and anal areas due to human papillomavirus (HPV types 6 and 11) infection. It is transmitted through sexual intercourse and in saunas and public bathrooms. It is generally not painful or itchy, but is prone to the formation and growth of new warts, and often recurs after treatment.
Topical medications, cryotherapy, and laser therapy are used, but it is known to cause recurrence in many cases. Imiquimod, an immunostimulant, is often prescribed as a topical medication, but it is known to cause intense inflammation around the area of application. As with common warts, there is a need for safe and effective antiviral medications.
Our drug candidate is an ointment that acts directly on condyloma acuminatum, and is expected to suppress HPV proliferation and repair dysplastic tissue. A clinical trial has already been started in Japan, and in a Phase I clinical trial on healthy volunteers, it has been confirmed to be highly safe.
Epidemic keratoconjunctivitis (EKC) is an inflammation caused by infection of adenovirus types 8, 19, 37, 53, 54, and 56 in the conjunctiva, and is accompanied by keratitis. The condition is highly infectious.
The incubation period is 8 to 14 days, and involves sudden onset with edema of eyelids and lacrimation. It causes swelling of preauricular lymph nodes, and development of corneal inflammation decreases transparency, with opacity in case persisting for up to a few years. Adenovirus, the causative virus of EKC, is mainly spread by hand contact, and infection extends within workplaces, hospitals, and households where people engage in close physical contact.
No effective antiviral drugs are available. Symptomatic treatment such as steroid eye drops are typically prescribed.
Seasonal influenza is caused by infection with influenza A and B viruses and is a recurring epidemic around the world. Severe cases kill between 290,000 and 650,000 people a year worldwide. Influenza viruses are susceptible to mutation and change their antigenicity slightly from year to year, leading to repeated epidemics. They can also mutate significantly over a period of years to decades, and completely new subtypes can emerge, which are known as discontinuous antigenic mutations and have the potential to cause a pandemic.
Several anti-influenza agents have been approved. The emergence of drug-resistant viruses has been reported for most of the approved drugs. This drug resistance and the potential for the emergence of large antigenic mutations necessitates the development of new antiviral drugs.
Dengue fever is an infectious disease caused by the dengue virus and transmitted by mosquitoes. Dengue fever starts with a sudden onset of fever, followed by a rash, headache, osteoarthritis, nausea and vomiting. The fever usually resolves 2-7 days after the onset of the disease, and the rash appears around the time the fever resolves. The disease can be particularly severe on reinfection, and in rare cases, it can develop into dengue hemorrhagic fever or dengue shock syndrome, which can be fatal if not treated promptly and appropriately.
A total of seven coronaviruses are known to infect humans, including four types of the cold syndrome and three types of severe pneumonia viruses of animal origin (SARS-CoV, MERS-CoV and SARS-CoV-2). The first four viruses cause common cold symptoms, but in most cases do not cause severe illness. The three severe pneumonia viruses can cause severe respiratory and other illnesses, such as COVID-19 caused by SARS-CoV-2, which is still raging around the world.
The antiviral drug “remdesivir” has been approved against COVID-19, but the development and approval of more effective antiviral drugs are eagerly awaited.
Down syndrome is a group of congenital disorders that are caused by a total of three chromosomes (trisomy) on chromosome 21. It is characterized by delayed physical development, distinctive facial features, and mild intellectual disability. It appears in 1 per 1,000 births per year and is the most common genetic disorder in newborns. In patients with Down syndrome, Alzheimer's disease is known to occur at a high rate after the age of 40 years.
Since Down syndrome is a chromosomal abnormality, there is currently no fundamental treatment for the condition. A Spanish research group has published the findings of a phase 2 clinical trial showing that a green tea extract, which has Dyrk1a inhibitory properties, improves cognitive function in patients with Down syndrome.
According to an estimate of Alzheimer's Disease International in 2015, one person in the world is diagnosed with dementia every 3 seconds. In Japan, a survey by a research group of the Ministry of Health, Labour, and Welfare showed that there are about 4.62 million patients with dementia as of 2012, which is expected to increase in the future. The brains of patients with Alzheimer's disease, which accounts for about half of the cases of dementia, shows accumulation of amyloid β and tau protein, which leads to neuronal death that causes symptoms such as forgetfulness. The cause of Alzheimer's disease has not been discovered and no curative treatment methods have been established; however, treatment for the abnormal aggregation of tau protein has gained attention in the recent years. The tau protein aggregated in the brain of the patient is hyperphosphorylated, suggesting a close relationship between the hyperphosphorylation of tau protein and neuronal death.
There are no curative treatment methods available at present.
Several drugs are used to improve the symptoms of dementia to a certain degree, and these take effect by increasing the neurotransmitters in the brain.
