Psoriasis
Clinical trial
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).
Aim of MC2-01
A fixed dose combination of calcipotriene and betamethasone dipropionate (“Calcipotriene/BDP”) is the best-in-class topical therapy for mild to moderate psoriasis with clinical trial efficacy data matching biologics after 4 weeks and superior to orals. However, current marketed formulations are greasy liquid oils/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 stabile cream formulation of Calcipotriene/BDP. Our aim is to develop the MC2-01 Cream into a new drug (NDA/MAA) with a superior real-life efficacy and safety profile. MC2-01 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 daily quality of life of patients and provide a cost effective treatment.
Clinical Stage
Ph III trial in the US is being prepared and will commence in 2017.
DRY EYES
Clinical trial
MC2-03 PAD™ EYE DROP – DRY EYES
About Dry Eye
Dry eye is one of the most prevalent ocular diseases. It is often chronic and can be progressive with a prevalence of up to 30%. Dry eye is a multifactorial disease 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 more common in women than in men and has been found to be significantly associated with aging.
Aim of MC2-03
Ciclosporine is widely used as an efficacious topical therapy for moderate to severe dry eye. However, current marketed formulations cause stinging and burning in the eyes of patients resulting in non-compliance and poor real-life efficacy.
Using PAD™ Technology and related know-how we have developed a new ciclosporine eye drop that is designed to uniquely improve delivery of cyclosporine into the eyes using a vehicle/eye drop that is highly tolerable. Our aim is to develop the MC2-03 eye drop into a low concentration, once daily new drug (NDA/MAA) with best-in-class efficacy and tolerability profile for treatment of severe dry eye disease. A solution intended to significantly improve daily quality of life of patients and provide a cost effective treatment.
Clinical Stage
Large pivotal phase II trial ongoing in Europe.
ATOPIC DERMATITIS
Clinical trial
MC2-11 PAD™ CREAM – ATOPIC DERMATITIS
About Atopic Dermatitis
Atopic dermatitis is a chronic rash characterized by inflammation and itching. An estimated 30-40 million people in the US and EU suffer from this condition, including between 8 and 18 % of infants and children.
Aim of MC2-11
Tacrolimus is the best non-steroidal topical therapy for moderate to severe atopic dermatitis with clinical trial efficacy data significantly superior to pimecrolimus (Elidel Cream) and crisaborole ointment. However, the current marketed formulation of tacrolimus (Protopic) is a greasy ointment 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 stabile cream formulation of tacrolimus MC2-11 Cream designed to deliver tacrolimus into the skin in quantities at least corresponding to Protopic 0.1%. Our aim is to develop two concentrations of MC2-11 Cream into new non-steroidal drugs (NDA/MAA) for adults and children with a best-in-class real-life efficacy profile. MC2-11 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 daily quality of life of patients and provide a cost effective treatment.
Clinical Stage
Pre-clinical – in preparation for phase II in 2017
PSORIASIS
Clinical trial
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 in 2-8 weeks due to risk of skin atrophy (ski thinning). Non-steroidal therapies can be used for long-term maintenance.
Aim of MC2-16
Calcipotriene is a best-in-class non-steroidal topical therapy for long-term treatment of mild to moderate psoriasis. However, the current marketed most efficacious formulations are greasy liquid oils/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 Cream designed to deliver significantly more calcipotriene into the skin compared to current ointment formulations. Our aim is to develop the MC2-16 Cream into a new non-steroidal drug (NDA/MAA) with a best-in-class real-life efficacy and safety profile. MC2-16 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 daily quality of life of patients and provide a cost effective treatment.
Clinical Stage
Pre-clinical – in preparation for Phase II in 2017
DRY AND ITCHY SKIN
Clinical trial
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 atopic dermatitis, contact eczema, uremic pruritus and some gene deficiencies. Causes of dry and itchy skin are multiple. Maintaining or restoring a health skin barrier is an important factor in treating dry and itchy skin.
Aim of MC2-21
Using PAD™ Technology and related know-how and based on a novel approach we have uniquely developed a non-steroidal cream 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 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 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 cost effective treatment.
Clinical Stage
Pre-clinical – in preparation for clinical trials in 2017