HSV-1 Keratitis - Competitive landscape, 2024

This “ HSV-1 Keratitis- Competitive landscape, 2024,” report provides comprehensive insights about 5+ companies and 5 drugs in HSV-1 Keratitis Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

HSV-1 Keratitis: Understanding

HSV-1 Keratitis: Overview

HSV-1 keratitis is a viral infection of the cornea caused by the herpes simplex virus type 1 (HSV-1). It is the most common cause of corneal blindness in developed countries. HSV-1 is typically associated with oral infections like cold sores, but it can also infect the eye, leading to keratitis. The virus can be transmitted through direct contact with infected secretions, often spreading to the eye via contaminated fingers or through the bloodstream from a primary infection elsewhere. Herpes simplex keratitis is primarily diagnosed by conducting a thorough clinical evaluation of patients suspected of having the condition, including history-taking and slit-lamp examination.

HSV-1 keratitis typically presents with symptoms such as eye pain, redness, blurred vision, and sensitivity to light (photophobia), and tearing. Patients may also experience a foreign body sensation in the eye. In recurrent cases, the symptoms can vary and may include decreased vision or visual disturbances due to corneal scarring. The infection often recurs, with the virus remaining latent in the trigeminal ganglion and reactivating during periods of stress, illness, or immunosuppression.

HSV-1 Keratitis potential complications include; Corneal ulcers or dendritic ulcers, Corneal scarring, which can lead to vision impairment and Recurrence of infection, which can cause repeated episodes of symptoms. The pathophysiology of HSV-1 keratitis involves the reactivation of the latent virus, which travels down the sensory nerves to the cornea.

The infection initially affects the superficial layers of the cornea, leading to epithelial keratitis, characterized by the presence of dendritic ulcers branching lesions on the cornea. If the infection progresses, it can involve deeper layers, causing stromal keratitis, which can lead to scarring, thinning of the cornea, and, ultimately, vision loss. The immune response to the virus also contributes to corneal damage, as the body's attempt to eliminate the virus can result in inflammation and tissue destruction.

The diagnosis of HSV-1 keratitis is primarily clinical, based on the characteristic appearance of dendritic ulcers on slit-lamp examination. Fluorescein staining of the cornea can enhance the visibility of these ulcers, which appear as bright, branching patterns. In uncertain cases, laboratory tests such as polymerase chain reaction (PCR) or viral culture from corneal scrapings can confirm the presence of HSV-1. Serological tests are generally not useful in acute cases but may help in distinguishing between primary and recurrent infections.

The treatment of HSV-1 keratitis typically involves antiviral medications, either topical or oral. Topical antiviral eye drops, such as trifluridine or ganciclovir, are commonly used to treat epithelial keratitis. Oral antivirals like acyclovir or valacyclovir may be prescribed, especially in cases of recurrent infections or to reduce the risk of recurrence.

In cases of stromal keratitis, corticosteroids may be added to the treatment regimen to reduce inflammation, but these must be used cautiously to avoid exacerbating the viral infection. Long-term prophylactic antiviral therapy may be considered for patients with frequent recurrences to prevent further episodes and reduce the risk of corneal scarring.

Report Highlights

• In August 2024, Excision BioTherapeutics, Inc. announced the Molecular Therapy Methods & Clinical Development publication of a preclinical study of EBT-104 in herpes simplex virus-1 keratitis (HSV-1 Keratitis).
• In May 2024, a recent study published in the Virology Journal, a group of researchers evaluated the antiviral efficacy and therapeutic potential of harmol in treating herpes simplex virus type 1 (HSV-1) induced keratitis, including drug-resistant strains, and its ability to enhance the effects of acyclovir (ACV).
• In May 2024, AiCuris published pharmacokinetic data for its lead candidate pritelivir (AIC316), an innovative therapeutic candidate targeting HSV replication. Pritelivir is currently being evaluated in a Phase III trial for the treatment of acyclovir-resistant HSV infections in immunocompromised patients.
• In June 2022, Shanghai BDgene Technology Co., Ltd. announced that BD111 had entered the stage of clinical research application for the registration of innovative biological products, and obtained the approval of Orphan drug designation from US FDA. BD111 had obtained the FDA orphan drug qualification, which will accelerate its clinical trials in the United States and the speed of drug registration and marketing.

HSV-1 Keratitis: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Novartis

Novartis International AG is a global healthcare company based in Switzerland, and one of the largest pharmaceutical companies in the world. Founded in 1996 through the merger of Ciba-Geigy and Sandoz, Novartis is involved in the research, development, manufacturing, and marketing of a broad range of healthcare products, with a focus on pharmaceuticals, generics, and biosimilar. Novartis has committed to sustainable healthcare solutions, including efforts to reduce environmental impact and improve global access to medicines. It also works on initiatives to provide affordable drugs in low- and middle-income countries.

Product Description: Famciclovir

Famciclovir is an antiviral medication used to treat infections caused by herpes viruses, including herpes simplex (HSV-1 and HSV-2). Famciclovir is a prodrug that is converted into penciclovir in the body, which works by inhibiting viral DNA replication, effectively controlling viral infections. Famciclovir (Famvir) is an oral antiviral medication that is being studied for its efficacy in treating herpes simplex virus (HSV) keratitis. Famvir has a long intracellular half-life, which may allow for persistent antiviral activity. It was originally developed and marketed by Novartis. Famvir® is a registered trademark of Novartis International Pharmaceutical Ltd.

HSV-1 Keratitis: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Shanghai BDgene Co., Ltd

Shanghai BD gene Co., Ltd. is a biotechnology company based in Shanghai, China. The company is involved in the development and commercialization of genetic and genomic technologies. BD gene specializes in providing genetic testing services, including genetic disease screening, drug metabolism testing, and personalized medicine. The company offers a range of products and services related to genomics, including high-throughput sequencing technologies and bioinformatics solutions. The company is involved in developing personalized medicine solutions, which involve tailoring medical treatment to the individual characteristics of each patient based on their genetic profile.

Product Description: Difelikefalin BD-111

BD111 is a gene editing treatment for viral keratitis developed based on BD mRNA delivery patent technology, and has completed 3 human clinical trials of IIT. It is the only technology of Cas9 mRNA delivery by lentivirus in the world, and also the second human clinical research project of CRISPR-Cas9 gene editing treatment in human body in the world. The drug uses bdgene's original delivery technology VLP to transduce CRISPR, directly target and cut the genome of HSV-1, so as to eliminate the genome of HSV-1 virus and achieve the treatment of herpesvirus keratitis.

BD111 is characterized by delivering cas9 mRNA, the gene enzyme stays in the body for a short time, which can reduce the immune response and reduce the risk of gene editing miss; it edits the viral genome, does not need to change any human genes, and has not detected the off target effect on the human genome. The drug is in Phase II stage of the development for HSV-1 Keratitis.

HSV-1 Keratitis Analytical Perspective

In-depth Commercial Assessment: HSV-1 Keratitis Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

HSV-1 Keratitis Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

HSV-1 Keratitis Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing HSV-1 Keratitis drugs?
• How many HSV-1 Keratitis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of HSV-1 Keratitis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the HSV-1 Keratitis therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for HSV-1 Keratitis and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• AiCuris Anti-infective Cures AG
• Shanghai BDgene Co., Ltd
• Excision BioTherapeutics, Inc

Key Products

• Pritelivir
• BD-111
• EBT-104

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