MC2-32/RGRN-305 Hidradenitis Suppurativa
(Oral)
About Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS) is a debilitating, inflammatory disorder with a high, unmet medical need. It is characterized by chronic, painful nodules, abscesses and suppurating sinus tracts that in the most severe form cause significant scarring. Commonly affected body locations include the axillary, infra- and intermammary, inguinal, perineal and gluteal regions. Patients may experience pain, itching, malodour, and a burning sensation. For many patients the disease has a huge impact on their quality of life.
The female/male ratio is 3:1 in the Caucasian population whereas this may not be the same in the Asian and African population. HS occurs most commonly in the third and fourth decades of life although also children can have the disease. It is sometimes difficult to diagnose HS and there is an average delay of 7-10 years between disease onset and diagnosis.
The disease mechanisms that cause HS are complex and not yet fully understood. However, HS is sometime described as an apocrinitis because blockage and inflammation in the apocrine glands around the hair follicles seems to be an important initial step in the disease pathogenesis. This results in increased expression of multiple pro-inflammatory cytokines and activation of a number of signaling pathways that together cause the skin manifestations seen in HS patients.
Treatment options are still limited and there is a high unmet medical need.
Clinical Stage
Phase 2
MC2-32/RGRN-305 HS
Active ingredient: Oral small molecule
Indication: Hidradenitis Suppurativa
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 made significant discoveries in the understanding of 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 for the treatment of CKD-aP stages 3-5.
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 Vulvar Lichen Sclerosus
(PAD™ Cream)
About Vulvar Lichen Sclerosus
Vulvar Lichen sclerosus (VLS) 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 VLS 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.
VLS is an autoimmune disease, and VLS 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 made significant discoveries in the understanding of urea associated skin diseases, including Vulvar Lichen Sclerosus.
Vulvar 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 vulvar 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 Vulvar Lichen Sclerosus
Active ingredient: Undisclosed di-peptide
Indication: Vulvar Lichen Sclerosus
Pipeline