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MC2-01 PAD™ Cream
Psoriasis

MC2-01 PAD™ Cream
Psoriasis

About Psoriasis
Psoriasis is an immune-mediated, inflammatory condition of the skin affecting nearly 3 % of the world’s population. As a chronic disease psoriasis has a substantial effect on the quality of life of patients. More than 80% of patients have mild to moderate psoriasis, for which topical therapies are first line of treatment. Patients with severe psoriasis are eligible for systemic therapies (orals and biologics), which are often used in combination with topicals

Aim of MC2-01
For patients suffering from plaque psoriasis the dual mode of action of calcipotriene and betamethasone dipropionate (“Calcipotriene/BDP”) provides fast relief of symptoms with just once daily application, while offering a superior safety profile. BDP counteracts potential skin irritation of calcipotriene while calcipotriene mitigates potential skin atrophogenic effect of BDP. However, current marketed Calcipotriene/BDP formulations are greasy Vaseline-like or liquid oils formulations that patients do not like to use, resulting in non-compliance and poor real-life efficacy.

PAD™ Technology uniquely enables a stabile PAD™ cream formulation of Calcipotriene/BDP that quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on in daily routines. A single drug designed for both (i) rapid relief; (ii) longer term safety and (iii) patient satisfaction – a new treatment experience for patients with plaque psoriasis.

Clinical Stage
US Phase 3 trial top line data is expected in Q3 2018 and NDA in H1’2019.

MC2-01 PAD™ Cream
Active ingredient: Calcipotriene/betamethasone dipropionate
Indication: Mild to moderate psoriasis

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MC2-03 PAD™ Eye Drop
Dry Eye

MC2-03 PAD™ Eye Drop
Dry Eye

About Dry Eye
Dry eye is one of the most prevalent ocular diseases affecting 7% to 30% of the population depending on geography. It is often chronic and can worsen with some patients progressing to moderate to severe dry eye. Dry eye, in particular in its moderate to severe form, is a multifactorial disorder caused by inflammation of the ocular surface that results in symptoms of discomfort such as eye dryness, overall eye discomfort, stinging, burning, a gritty feeling or fluctuating blurry vision. Dry eye is most common in women and increases in prevalence with age.

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. However, currently marketed ciclosporin formulations have sub-optimal efficacy profiles and cause stinging and burning in the eyes of patients resulting in frequent non-compliance, poor real-life efficacy or treatment discontinuation.

Using PAD™ Technology and related know-how we have developed a new PAD™ ciclosporin eye drop that is designed to uniquely improve delivery of ciclosporin to ocular surface tissues using a PAD™ formulation that is highly tolerable. Our aim is to develop a low strength, once daily new drug with best-in-class efficacy and tolerability profile for treatment of moderate to severe dry eye disease. A solution intended to significantly improve daily quality of life of patients and provide an attractive value proposition to payers, ophthalmologists and patients.

Clinical Stage
Phase 2 (n=265) top line data is expected in Q3 2018.

MC2-03 PAD™ Eye Drop
Active ingredient: Ciclosporin
Indication: Moderate to severe dry eye

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MC2-11 PAD™ Cream
Atopic dermatisis

MC2-11 PAD™ Cream
Atopic Dermatitis

About Atopic Dermatitis
Atopic dermatitis (also known as AD) is the most common type of eczema. More than 40 million people in the US and Europe have atopic dermatitis — which often appears as a red, itchy rash normally on the cheeks, arms and legs. Atopic dermatitis typically begins in childhood, usually in the first six months of a baby’s life. Even though it’s a common form of eczema, it’s also severe and long-lasting. Often, atopic dermatitis disappears as a child grows older, though some children will have atopic dermatitis flares into adulthood. Research also shows that some people with eczema, especially atopic dermatitis, have a mutation of the gene responsible for creating filaggrin. Filaggrin is a protein that helps our bodies maintain a healthy, protective barrier on the very top layer of the skin. Without enough filaggrin to build a strong skin barrier, moisture can escape and bacteria, viruses and more can enter. This is why many people with atopic dermatitis have very dry and infection-prone skin.

Aim of MC2-11
Tacrolimus formulated in an Vaseline-like ointment is currently the most potent non-steroidal topical therapy for atopic dermatitis. However, the current marketed formulations of tacrolimus (0.1% and 0.03%) are greasy ointments that patients do not like to use, resulting in non-compliance and poor real-life efficacy. In addition such therapies do not address the symptom of very dry and infection-prone skin.

Using PAD™ Technology we aim to make a PAD™ cream based tacrolimus drug for treatment of moderate to severe atopic dermatitis that not only is anti-inflammatory, but also addresses the very dry and infection-prone skin.

MC2-11 PAD™ Cream quickly absorbs into the skin leaving it nicely moisturized allowing patients to move on in daily routines. A solution intended to significantly improve daily quality of life of patients and provide a unique value proposition to payers, physicians and patients.

Clinical Stage
Pre-clinical – in preparation for phase 2a dose-finding study.

MC2-11 PAD™ Cream
Active ingredient: Tacrolimus
Indication: Atopic Dermatitis

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MC2-16 PAD™ Cream
Psoriasis

MC2-16 PAD™ Cream
Psoriasis

About Psoriasis
Psoriasis is an immune-mediated, inflammatory condition of the skin affecting nearly 3 % of the world’s population. As a chronic disease psoriasis has a substantial effect on the quality of life of patients. More than 80% of patients have mild to moderate psoriasis, for which topical therapies are first line of treatment. While steroid based drugs are often used for acute treatment non-steroids such as calcipotriene is used for long term maintenance therapy in between flare ups.

Aim of MC2-16
Calcipotriene is a best-in-class non-steroidal topical therapy for long-term treatment of mild to moderate plaque psoriasis. However, the currently marketed most efficacious calcipotriene formulations are greasy ointments that patients do not like to use, resulting in non-compliance and poor real-life efficacy.

Using PAD™ Technology and related know-how we have uniquely developed a PAD™ cream formulation of calcipotriene MC2-16 Cream designed for better efficacy and patient acceptance compared to current ointment formulations. MC2-16 PAD™ Cream is moisturizing, convenient to use and it quickly absorbs into the skin allowing patients to move on in daily routines. A solution intended to significantly improve quality of life of patients and provide an attractive value proposition to payers, physicians and patients.

Clinical Stage
Pre-clinical – in preparation for phase 2

MC2-16 PAD™ Cream
Active ingredient: Calcipotriene
Indication: Mild to moderate psoriasis

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MC2-02 PAD™ Cream
Uremic pruritus

MC2-02 PAD™ Cream
Uremic Pruritus

About Uremic Pruritus
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, strongly reducing the patient’s quality of life. More than 40% of patients undergoing hemodialysis suffer from chronic pruritus and very dry skin strongly reducing the patient’s quality of life as they are deprived from sleep. The cause is incompletely understood, and it is often difficult to eradicate, although symptoms can usually be mitigated. 60 – 70% of dialysis patients experience pruritus and dry skin. And despite this clear unmet medical need, there is no approved treatment for uremic pruritus in Europe or the US.

Aim of MC2-02
Using PAD™ Technology, related know-how and based on a new understanding of the root cause of uremic pruritus we have uniquely developed a non-steroidal cream formulation designed to (i) relieve the itch; (ii) repair the skin barrier; and (iii) providing a moisturizing, yet non-greasy barrier on top of the skin. Our aim is to develop the MC2-02 PAD™ Cream into a new non-steroidal topical cream (medical device) for treatment of uremic pruritus. We are using a novel approach – yet undisclosed.

MC2-02 PAD™ Cream is non-stinging, moisturizing, convenient to use and it quickly absorbs into the skin allowing patients to move on in daily routines. A solution intended to significantly improve daily quality of life of patients and provide a unique value proposition to physicians, patients and payers.

Clinical Stage
In preparation for clinical trials in Q1 2019.

MC2-02 PAD™ Cream
Medical Device
Indication: Uremic Pruritus

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