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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
A fixed dose combination of calcipotriene and betamethasone dipropionate (“Calcipotriene/BDP”) is a highly efficacious and safe topical therapy for rapid relief of symptoms as well as long-term maintenance therapy for mild to moderate plaque psoriasis. However, current marketed calcipotriene/BDP formulations are greasy formulations that patients do not like to use, resulting in non-compliance and poor real-life efficacy.

Using PAD™ Technology we have uniquely developed a 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) long-term maintenance of remission and (iii) patient adherence with the aim to introduce a new treatment paradigm for mild to moderate psoriasis.

Clinical Stage
Phase 3 trial in the US is planned to commence in Q3 2017.

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 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
Large phase 2 trial ongoing in Europe.

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

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MC2-11 PAD™ Cream
Inverse psoriasis

MC2-11 PAD™ Cream
Inverse psoriasis

About Inverse 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. Inverse psoriasis (in skin folds) is one of several types of psoriasis that is particular sensitive to therapy.

Aim of MC2-11
Inverse  psoriasis affects the skin inside the folds of the body. The skin in these areas is more sensitive, so the condition can be a challenge to manage and treat. Steroids are not suitable.

Tacrolimus ointment is recommended for and often used off-label as therapy for such areas. However, in addition to not having the appropriate label, the current marketed formulations of tacrolimus (Protopic 0.1% and 0.03%) are greasy ointments that patients do not like to use, resulting in non-compliance and poor real-life efficacy.

Using PAD™ Technology we aim to make a PAD™ cream based tacrolimus drug labelled for treatment of mild to moderate psoriasis including inverse psoriasis.

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: Mild to moderate psoriasis, including inverse psoriasis.

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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. Patients with severe psoriasis are eligible for systemic therapies (orals and biologics). Topical therapies based of potent steroids may only be used daily for 2-8 weeks due to risk of skin atrophy (skin thinning). Non-steroidal therapies on the other hand can be used as long-term maintenance therapies.

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 cream formulation of calcipotriene MC2-16 PAD™ Cream designed to deliver significantly more calcipotriene into the skin compared to current ointment formulations. Our aim is to develop the MC2-16 PAD™ Cream into a new non-steroidal drug with best-in-class real-life efficacy and patient acceptance. 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 (long-term)

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MC2-21 PAD™ Cream
Dry and itchy skin

MC2-21 PAD™ Cream
Dry and itchy skin

About Dry and Itchy skin
Dry and itchy skin is one of the most common dermatological complaints of patients, in particular in the elderly and patients suffering from contact eczema, uremic pruritus and some gene deficiencies. Causes of dry and itchy skin are multiple. Maintaining or restoring a healthy skin barrier is an important factor in treating dry and itchy skin.

Aim of MC2-21
Using PAD™ Technology, related know-how and based on a novel approach we have uniquely developed a non-steroidal cream formulation designed to (i) be highly tolerable to fissured and cracked skin; (ii) deliver certain excipients into the skin; and (iii) providing a moisturizing, yet non-greasy barrier on top of the skin. Our aim is to develop the MC2-21 PAD™ Cream into a new non-steroidal topical cream (medical device) for treatment of a specific subset of patients suffering from dry and itchy skin including a large portion of patients with atopic dermatitis. We are using a novel and patented approach – yet undisclosed.

MC2-21 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 and patients.

Clinical Stage
Pre-clinical – in preparation for clinical trials in 2017

MC2-21 PAD™ Cream
Active ingredient: Un-disclosed
Indication: Dry and itchy skin

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