Addressing Skin Conditions That Are Underserved
An estimated 100 million people in the developed world form scars following surgery (1). In the U.S. there are approximately eight million surgical procedures performed annually wherein scarring is a concern (2). Scarring results from abnormal deposition and organization of collagen, with no difference between normal and scarred skin in composition of dermal tissue. The pathogenesis of scar formation is poorly understood. Scarring can have negative physical, aesthetic, and psychological effects if left untreated. There are no approved drugs for scar prevention following surgery; treatments are limited to pressure dressings, silicone sheeting/gels, steri-strips, and steroid injections.
Rosacea is a common skin condition that affects over 16 million individuals in the U.S. and, according to some estimates, hundreds of millions of people worldwide (3). Rosacea is a chronic relapsing inflammatory skin disease primarily affecting the face. Rosacea comprises uncontrolled vasodilation, inflammation, and later fibrosis associated with glandular hyperplasia which presents as persistent erythema. This disease is thought to be under treated, as it’s often mischaracterized as acne. Current treatments consist of oral and topical medications that are taken or administered daily with limited efficacy.
AiViva is developing AIV-001 to address the negative impacts that scarring and rosacea can have on patients.
1. Sund, 2000. 2. American Society of Plastic Surgeons. 3. Berg M, Liden S. An epidemiological study of rosacea. Acta Dermato-Venereologica. 1989;69:419-423.
Addressing Unmet Needs in Neovascular AMD
Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular age-related macular degeneration (nAMD) is a chronic eye disorder that causes blurred vision or a blind spot in the visual field. It is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision. Neovascular AMD affects 11 million people in the United States and is the leading cause of vision loss in people age 50 and older. The number of people with nAMD is expected to double as the population continues to age (1). The mainstay treatment modality for nAMD involves intravitreal (IVT) injectable anti-VEGF therapies, with the leading drugs accounting for approximately $8 billion in sales in 2018 (2). Anti-VEGF therapies have shown treatment success, however, the disadvantages of current treatment therapies include frequent visits to the Ophthalmologist for intravitreal injections, development of tolerance, and development of subretinal scarring (3, 4).
AiViva is developing AIV-007, its proprietary gel formulation, as a potentially once every 6-month injection to reduce the treatment burden for patients and physicians.
1. Pennington, K., et al. Epidemiology of age-related macular degeneration (AMD) 2. IMS Revenue Data & SEC filings 3. Daniel, E. et al. Risk of Scar in the Comparison of Age-related Macular Degeneration Treatments Trial, 2014. 4. Daniel, E. et al. Development and Course of Scars in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT), 2018.
A Differentiated Approach to Treating Urological Disorders
Benign Prostatic Hyperplasia (BPH)
Benign prostatic hyperplasia (BPH) is a non-malignant growth of the prostate that occurs in an estimated 38 million men in the United States (1). An enlarged prostate contributes to lower urinary tract symptoms (LUTS) including frequent urge incontinence, nocturia, painful urination, weak flow, small void volume, and sexual dysfunction. BPH is managed by active surveillance; medication to treat LUTS, including alpha blockers, 5-alpha-reductase-inhibitors, anticholinergics, or a combination of therapies; or surgery including trans-urethral resection of the prostate (TURP) (2). Oral medications that treat BPH have adverse sexual side effects, and many men are uncomfortable undergoing surgery to treat their BPH symptoms.
AiViva is developing AIV-007 as an intraprostatic treatment for localized hyperplasia, thus improving treatment options and reducing the exposure to risk of adverse effects associated with oral drugs and surgery.
1. Adapted from Amerson D. Urolift for BPH: Changing the Game In BPH Care 2. Parsons, J.K. Benign Prostatic Hyperplasia and Male Lower Urinary Tract Symptoms: Epidemiology and Risk Factors.
Leveraging Our Technology in Oncology
Nonmelanoma Skin Cancer (NMSC)
Nonmelanoma skin cancer (NMSC) is the most common malignancy in the United States, with substantial associated morbidity and cost, which could lead to mortality (1). NMSC is the most common form of cancer in Caucasians, with continually increasing in incidence worldwide. Basal cell carcinoma (BCC) accounts for 75% of NMSC cases, and squamous cell carcinoma (SCC) accounts for the remaining majority. It is estimated that 2-3 million new cases of NMSC occur worldwide each year (2). NMSC is caused by sun exposure, with increased risk of developing NMSC with advancing age. Current treatment options include topical creams and surgery to remove the lesions. However, many lesions occur in cosmetically sensitive areas such as the face, and removing them with surgery often results in scarring.
AiViva is developing AIV-001 as an intradermal therapy to eliminate or reduce the need for surgery in the treatment of NMSC.
Solid Tumors and Other Cancers
AiViva’s JEL™ Technology has broad applicability in transforming the treatment of solid tumors. Our investigational program in oncology uses our proprietary technology to directly target solid tumors. Nonclinical in vivo studies demonstrated efficacy of tumor regression associated with our product in certain tumor types. AiViva continues to advance research on our oncology program as potential monotherapy or in combination with other drugs for the treatment of certain types of solid tumors.
1. Rogers, H.W., et al. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the US Population, 2012 2. Samarasinghe, V., et al. Nonmelanoma Skin Cancer