The Swedish biotech is now eligible for several incentives in the two regions, according to the designations. Both agencies will provide regular feedback during the application process and waive certain fees. The FDA also offers seven years of market exclusivity while the EMA promises ten years of protection from competition.
Systemic sclerosis, also known as scleroderma, is a progressive autoimmune disease characterised by inflammation and fibrosis. Not only is skin hardened in this condition, but internal organs can be affected too. Interstitial lung disease (ILD) is one of the most common disease consequences, occurring in approximately 80% of patients. Though no approved therapies are treating the underlying cause of the disease, the FDA has approved drugs that manage associated complications.
AnaMar says that there are no treatments on the market that stop or reverse scarring in both lung and skin tissue. The biotech says its candidate has a dual-action approach to treat both these aspects of the disease.
AM1476 has established pharmacokinetic and safety profiles based on Phase I data. An already-designed Phase II trial will evaluate the treatment effects of AM1476 in 60 patients with systemic sclerosis-associated ILD. Patients’ lung function and skin thickness will be assessed over a year.
Australian biotech Certa Therapeutics gained FDA orphan drug designation for its systemic sclerosis candidate. Certa’s FT011 is also an oral anti-fibrotic agent. The company has already unveiled positive results from a Phase II trial assessing patients’ skin, with pivotal trial plans underway.
GSK is also targeting scleroderma treatment with its B-cell inhibiting monoclonal antibody Benlysta (belimumab). Its candidate received an FDA orphan drug designation in February 2023. Though the company said it planned to initiate a Phase II/III trial in the first half of 2023, no updates have been issued since.
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