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AnaMar secures double orphan drug designation for systemic sclerosis drug

2024-02-05

孤儿药上市批准临床2期临床1期临床结果

Not only is skin hardened in systemic sclerosis, but internal organs are also affected too. Image credit: Shutterstock/Numstocker.

AnaMar has received orphan drsystemic sclerosisr its systemic sclerosis candidate AM1476 from the FDA and the EMA.

AnaMaredish biotech is now eligible for several incensystemic sclerosisegions, accAM1476 to the deFDAnations. EMAh 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.

AnaMar’s AM1476 is an oral antagonist of the 5-hydroxytryptamine receptor (5-HT2B) receptor, which is also known as a serotonin receptor. The company says its candidate halts key signalling pathways associated witFDAibrosis in a 5 February press release.EMA

AnaMaric AM1476sis, also known as scleroderma5-hydroxytryptamine receptor (5-HT2B) characterised by inflammation and fserotonin receptoris skin hardened in this condition, but internal organs can be affected too. Infibrosisal 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.

Systemic sclerosisim’s Ofev (nintesclerodermame the progressive autoimmune diseasesystemic sclerosisinflammationILD wfibrosisFDA approved the tyrosine kinase inhibitor in September 2019. Genentech’s subcutaneous iInterstitial lung disease (ILD)followed as the first biologic with FDA approval in March 2021.FDA

Boehringer Ingelheim MeOfev (nintedanib)tiations underway as US drug prices risesystemic sclerosis-associated ILD FDA tyrosine kinase Genentech Actemra tocilizumab FDA

Inmagene to secure licence for two HUTCHMED drug candidates

The market for systemic sclerosis is expected to be worth $2.05bn in 2030, as per GlobalData’s Pharma Intelligence Centre.

Inmageneta is the parent company of Pharmaceutical Technology.

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 estasystemic sclerosisnetic and safety profiles based on Phase I data. An already-dePharma Intelligence Centre 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 TherapeuticPharmaceutical Technologydesignation 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.

AnaMar also targeting scleroderma treatment with its B-cell inhibiting monocscarringtibody 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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