Xentria has received orphan drug designation (ODD) from the European Medicines Agency (EMA) for its anti-TNFα monoclonal antibody, XTMAB-16.
The company has also enrolled the first US patient in a Phase Ib/IIa clinical study to assess XTMAB-16 for the treatment of patients with pulmonary sarcoidosis.
Pulmonary sarcoidosis is a chronic, multisystem inflammatory disorder.
XTMAB-16 is being developed as a new biologic solution to treat pulmonary sarcoidosis with or without extra pulmonary involvement.
It has the potential to disrupt an inflammatory pathway and slow down the formation of granulomas by blocking TNFα.
Xentria president Tom Shea said: “Receiving designation of orphan drug from the EMA in the EU, in addition to the US, for our lead candidate XTMAB-16 further highlights the real need for ongoing drug development in rarer conditions such as sarcoidosis.
“This designation further validates the potential of XTMAB-16 to fill the existing treatment gap in pulmonary sarcoidosis across the world.
“We have now enrolled our first patient into the study and believe the potential for this treatment could make a big difference for those suffering from the disease.”
In November 2020, the company received ODD from the US Food and Drug Administration (FDA) for XTMAB-16.
A Phase I clinical trial involving healthy volunteers concluded last year.
Broad analyses have been carried out to show the physio-chemical properties and pharmacology of XTMAB-16 as a TNFα inhibitor.