Systemic Sclerosis Associated Raynaud Phenomenon (RP)/ Digital ulcers (DU) (SSc-RP/DU)
Systemic sclerosis, also known as scleroderma, is a rare autoimmune disease primarily characterized by systemic microvascular abnormalities. Abnormal proliferation of blood vessel walls, tissue ischemia, and persistent immune system inflammation lead to fibrosis in the skin and internal organs. Scleroderma can cause interstitial lung disease and pulmonary arterial hypertension, with respiratory failure being the primary cause of death in scleroderma patients. Additionally, scleroderma can also cause secondary Raynaud's phenomenon, which is an exaggerated vascular response to cold or emotional stress. It can result in arterial narrowing in peripheral areas such as the fingers or toes, limiting blood supply. This can lead to discoloration due to ischemia and in severe cases, tissue necrosis, ultimately resulting in amputation.
Currently, the treatment for Raynaud's phenomenon associated with scleroderma involves injectable formulations of prostacyclin analogs. However, this treatment requires a significant amount of time and causes inconveniences as well as injection site pain.
By developing a new inhalation delivery method for long-acting sustained-release medications, hospitalization time for the treatment of scleroderma-related Raynaud's phenomenon can be reduced. Patients can administer the medication at home, enabling them to maintain a normal lifestyle and reducing healthcare personnel and costs.
According to the market strategy plan, the introduction of L608 for the treatment of scleroderma-related Raynaud's phenomenon will begin in the United States and Europe before expanding to global markets.