MC2-03 Sjogren Keratitis
(PAD™ Cream)
About Sjogren Keratitis
Keratitis is a dry eye disease is one of the most prevalent ocular diseases affecting 7% to 30% of the population depending on geography. In the US, prevalence estimates of dry eye range from 5% to 34% in individuals over 50 years old.
It is often chronic and can worsen, progressing to moderate to severe dry eye. Dry eye, in its moderate to severe form, is a multifactorial disorder caused by inflammation of the ocular surface that result in symptoms of discomfort such as eye dryness, overall eye discomfort, stinging, burning, a gritty feeling or fluctuating blurry vision. Known risk factors for dry eye include female sex, increasing age, and certain comorbid conditions such as autoimmune diseases and medications.
In Sjogren’s Disease, the mucous membranes and moisture-secreting glands of the eyes and mouth are usually affected first, resulting in decreased tears and saliva. Incidence rates show that Sjogren’s Disease is affecting 0.5% to 1.0% of the population. Most symptoms usually appear between the ages of 45 and 55 and about half of patients also have rheumatoid arthritis or other connective tissue diseases, such as lupus.
Aim of MC2-03
Ciclosporin is widely used as a therapeutic agent in eye drops for treatment of patients with moderate to severe dry eye. Current formulations for treatment of patients with moderate to severe dry eye have sub-optimal efficacy profiles and may cause stinging and burning in the eyes of patients.
Using PAD Technology™ we have developed a new PAD based eye drop formulation designed to improve delivery of Ciclosporin to ocular surface tissues and conjunctiva to reduce inflammation without causing stinging and burning in the eyes.
MC2-03 has the potential to be first therapy for treatment of Sjogren Keratitis disease. A treatment intended to significantly improve the daily quality of life of patients and provide an attractive value proposition to multiple stakeholders such as patients, physicians, and societies.
Clinical Stage
Phase 2 (n=265) successfully completed. Phase 3 ready.
MC2-03 Sjogren Keratitis
Active ingredient: Ciclosporin
Indication: Sjogren Syndrome Keratitis and moderate to severe Dry Eye
Pipeline
MC2-25 CKD-aP
(PAD™ Cream)
About CKD-aP (Uremic Pruritus)
Chronic kidney disease (CKD) refers to all five stages of kidney damage, from very mild damage in stage 1 to complete kidney failure in stage 5. The stages of kidney disease are based on how well the kidneys filter waste and extra fluid out of the blood. The most severe cases are at CKD stages 3-5 and Uremic Pruritus, or chronic kidney disease-associated pruritus (CKD-AP) remains a frequent and compromising symptom in patients with advanced or end-stage renal disease.
The prevalence of CKD associated pruritus is estimated at 38m people in the US and EU and for CKD-aP stages 3-5 patients the prevalence of moderate to severe pruritus is about 42%. CKD-aP stage 3 accounts for more than 50% of this patient population.
Most patients living with CKD associated pruritus has significant impacts on health-related quality of life (HR-QoL) in terms of mood, social relations, and sleep.
The cause of the disease is until now not well understood in complete details and because of this poorly understood pathophysiology, treatment options today are often empirical.
There is a significant unmet medical need with no approved treatment for CKD-aP stages 3 and 4 in Europe or the US.
Aim of MC2-25 CKD-aP
MC2 has conducted a breakthrough discovery of a novel treatment paradigm applicable for treatment of certain urea associated skin diseases including CKD-aP.
MC2-25 is a di-peptide formulated in a PAD Technology™ based cream under development as a drug candidate to (i) relieve the itch; (ii) repair the skin barrier; and (iii) providing a moisturizing, yet non-greasy barrier on top of the skin.
MC2-25 CKD-aP is formulated to be highly tolerable, moisturizing, convenient to use and it quickly absorbs into the skin allowing patients to get on with their life and their daily routines. A novel treatment solution intended to significantly improve daily quality of life of patients and provide a unique value proposition to multi stakeholders such as patients, physicians, and societies.
Clinical Stage
Phase 2 ongoing
MC2-25 CKD-aP
Active ingredient: Undisclosed di-peptide
Indication: CKD-aP (stages 3-5)
Pipeline
MC2-25 Lichen Sclerosus
(PAD™ Cream)
About Lichen Sclerosus
Lichen sclerosus (LS) is a chronic, inflammatory, cutaneous disorder that can lead to scarring, impaired sexual function, and malignancy. It is thought to be underdiagnosed and undertreated. If it is not treated, lichen sclerosus is associated with a greater degree of pain, scarring and an elevated risk of cancer in the genital area.
While LS can affect any area of the body of both males and females, it has a predilection for female anogenital epithelium. Extragenital involvement is reportedly present in 6% to 20% of patients.
The typical lichen sclerosus patient is a woman around 50 years of age with external genital itch. The urge to itch and scratch is very strong and when asking patients, pain during sexual intercourse is often described.
LS is an autoimmune disease, and LS patients have a higher risk of suffering from other autoimmune diseases. Despite a clear unmet medical need, there is no approved treatment for lichen sclerosus in Europe or the US.
Aim of MC2-25
MC2 has conducted a breakthrough discovery of a novel treatment paradigm applicable for treatment of certain urea associated skin diseases, including genital Lichen Sclerosus.
Genital Lichen Sclerosus is a very debilitating disease with severe impact on quality of life for both women and men in all ages. A large part of my clinical research has been focused on the causal role of urine in Lichen Sclerosus. MC2 Therapeutics has made a breakthrough discovery in elucidating the pathology of Lichen Sclerosus, and our novel treatment paradigm has strong potential to help the many patients who have no effective treatment options today.
MC2-25 is a di-peptide formulated in a PAD Technology™ based cream under development as a drug candidate to relieve symptoms and repair the genital skin damage.
MC2-25 is formulated to be a highly tolerable and convenient to use. A solution intended to significantly improve daily quality of life of patients and provide a unique value proposition to multiple stakeholders including patients, physicians, and societies.
Clinical Stage
Phase 2 in planning for H2 2023
MC2-25 Lichen Sclerosus
Active ingredient: Undisclosed di-peptide
Indication: Lichen sclerosus
Pipeline
MC2-11 Atopic Dermatitis
(PAD™ Cream)
About Atopic Dermatitis
Atopic dermatitis (AD) also called eczema, is a common chronic or recurrent inflammatory skin disease that affects 15–20% of children and 1–3% of adults worldwide.
AD often appears as a red, itchy rash normally on the cheeks, arms, and legs. AD typically begins in childhood, usually in the first six months of a baby’s life. Even though it is a common form of eczema, it is also severe and long-lasting. Many people with AD have very dry and infection-prone skin.
A significant economic burden is associated with atopic dermatitis (AD). The total annual burden of AD direct and indirect cost is $37.7 billion.
Aim of MC2-11
There is a need for a topical formulation that can deliver a fast and effective relief of inflammation and itch while providing essential ingredients for a healthy skin barrier.
Using PAD Technology™ we aim to make a PAD cream-based treatment of moderate to severe atopic dermatitis that not only is anti-inflammatory, but also addresses the very dry and infection-prone skin. We are also evaluating MC2-11 for the treatment of Vitiligo.
MC2-11 PAD™ Cream is designed to quickly absorb into the skin allowing patients to focus on their daily routines and get on with their lives. A solution intended to significantly improve daily quality of life of patients and provide a unique value proposition to patients, physicians, and societies.
Clinical Stage
In preparation for Phase 2
MC2-11 Atopic Dermatitis
Active ingredient: Tacrolimus
Indication: Atopic Dermatitis
Pipeline
MC2-22 Atopic Dermatitis
(PAD™ Cream)
About Atopic Dermatitis
Atopic dermatitis (known as AD) also called eczema, is a common chronic or recurrent inflammatory skin disease that affects 15–20% of children and 1–3% of adults worldwide.
AD often appears as a red, itchy rash normally on the cheeks, arms, and legs. AD typically begins in childhood, usually in the first six months of a baby’s life. Even though it is a common form of eczema, it is also severe and long-lasting. Many people with AD have very dry and infection-prone skin.
A significant economic burden is associated with atopic dermatitis (AD). The total annual burden of AD direct and indirect cost is $37.7 billion.
There are as many as 9.6% new cases of AD in children.
Aim of MC2-22
Using PAD Technology™ we aim to develop a significantly improved topical PAD™ cream formulation for treatment of mild to moderate atopic dermatitis while addressing the dry, itchy and infection-prone skin.
Clinical Stage
Preparation for phase 2
MC2-22 Atopic Dermatitis
Active ingredient: Crisaborole
Indication: Mild to moderate atopic dermatitis
Pipeline