Alphyn’s initial product is expected to be the first product to treat all the problems of Atopic Dermatitis (AD), both the immune response and bacterial problems, including the AD problems caused by the drug resistant MRSA bacteria.

AD greatly impacts the quality of life for 32 million Americans each year.¹  A multi-center, vehicle-controlled, randomized and double-blind Phase 2a clinical trial of AB-101a enrolling adult and pediatric patients ages 2 and up for mild to moderate AD is currently underway. The global AD market is estimated at $18.1 billion growing to $34.1 billion by 2026.²  Fully 70% of AD sufferers report unbearable itch with 55% reporting their AD is not under control.¹  AD significantly affects lifestyle resulting in 5.9 million lost workdays each year.¹  There is a 160% increase in the risk of suicide for AD patients.³  A solution is clearly needed.  AB-101a’s test results and mechanisms of action are directly targeted to be the answer.

The treatment of AD has recently evolved.  Traditional clinical practice viewed AD as an autoimmune disease with immune response problems and no bacteria involvement unless an infection develops.

The new change in clinical practice views AD as including bacteria involvement, where bacteria make AD worse and prevent healing, along with the autoimmune component.  New clinical practice is to treat the immune responses problems and the bacteria problems.

AD severity is proportional to the number of bacteria present on the AD-affected skin, in particular the number of Staphylococcus aureus (or Staph) bacteria.  Staph as it lives on the skin (usually referred to as colonizing the skin) releases toxins which AD-affected skin is sensitive increasing the itch and inflation of AD and preventing the AD from healing.

When bacteria reach a point that they cause infection in the AD-affected skin, the AD problem becomes worse and more difficult to treat.  When AD becomes infected, in addition to treating the itch and inflammation caused by bacteria, the infection must be treated to begin the healing process.

And, when the bacteria colonization and infection is caused by the drug resistant strain or variant of Staph named Methicillin-resistant Staphylococcus aureus generally known as MRSA, the problem is much more serious and difficult to resolve.  Being drug resistant, MRSA is difficult to kill.  MRSA infections can become life threatening.  MRSA infections are reported in AD to be as much as 36%.⁴

Eliminating the bacteria from AD-affected skin is now known to be of critical importance to reduce the misery and potentially life threating problems of AD and allow it to begin to heal.

AB-101a with its multiple bioactives and resulting Multi-Target Therapeutics™ technology is expected to treat all the problems of AD:  AB-101a multiple mechanisms of action are expected to attack and eliminate inflammation, attack and eliminate itch and attack and kill Staph bacteria, its MRSA drug resistant variant and other bacteria with their drug resistant variants.

One product that addresses the multiple problems of AD, eliminating the need for AD sufferers to use multiple therapeutics, will be a great benefit to physicians and AD sufferers.  AB-101a is expected to be that product providing complete, fast and effective relief for AD patients.

A product that reduces, and even better eliminates, side effects and problems found with the current and experimental AD therapies would be of prime benefit to physicians and AD sufferers.  AB-101a is expected to be that product as it is anticipated to eliminate the side effects and trade-offs of existing and other new treatments.  AB-101a has the advantages of being:

• Free of steroids
• Non drowsy
• Not requiring a series of painful injections
• Gentle on the skin and expected to be effective in resolving the problems of AD

AB-101a’s Multi-Target Technology, combined with its topical delivery, is expected to provide clear safety and efficacy advantages over current and experimental topical and systemic AD therapeutics.

Alphyn’s second product is expected to target Epidermolysis Bullosa (or EB), an Orphan Drug disease.  EB is a rare genetic skin disease afflicting approximately ½ million people worldwide⁵, primarily children.  It has a number of genetic and symptomatic variations all sharing the prominent symptom of extremely fragile skin that blisters and tears from minor friction or trauma.⁶  Decreasing pain, inflammation and itch, and, fighting skin infection can significantly improve the quality of life for EB sufferers.  Infection is one of the leading causes of death among patients who unfortunately suffer from this terrible incurable genetic skin disease.

Today there is no treatment or cure for EB.  The current standard of care for EB is supportive, which includes daily wound care, pain management, and protective bandaging.⁶

AB-101b is expected to benefit people afflicted with EB in the same way it is expected to benefit AD sufferers, specifically targeting inflammation, itch and bacteria including bacteria infection and infection from the drug resistant MRSA bacteria.

Alphyn’s first product for AD benefits from a faster, lower cost path to FDA marketing authorization, confirmed by FDA, because it starts at the Phase 2 human clinical trial.  The AB-101 FDA marketing authorization path is much faster and lower cost than is usual for drug products.

Alphyn anticipates its additional pipeline topical products will proceed through FDA marketing authorization in the same way, foregoing many of the preclinical, animal and Phase 1 human clinical trial:

¹  National Eczema Association, Facts.  www.nationaleczema.org/research/eczema-facts/

²  “Global Atopic Eczema Treatment Market” report:  AD at $18.1 Billion in 2019 , $34.1 Billion 2026, Global Atopic Dermatitis Market 2020, Facts & Factors

³  Suicidal Ideation … in Adolescents with Eczema, a population study.  Halvorsen et al.  Journal of Investigative Dermatology. 2014.

⁴ Antibiotic Susceptibility of Staphylococcus aureus in Atopic Dermatitis: Current Prevalence of Methicillin-Resistant Staphylococcus aureus in Korea and Treatment Strategies, Jung et al, Annals of Dermatology, 2015.  www.ncbi.nlm.nih.gov/pmc/articles/PMC4530149/

⁵  Raising Awareness Among Healthcare Providers about Epidermolysis Bullosa and Advancing Toward a Cure, Tabor et al,
www.ncbi.nlm.nih.gov/pmc/articles/PMC5479476/pdf/jcad_10_5_36.pdf

⁶  The Deborah Society, www.debra.org/about-eb/eb-depth?gclid=EAIaIQobChMI1IjF0bKN8AIVmUlyCh2ZAQSVEAAYAiAAEgKH4PD_BwE