Certa Therapeutics, a biotech company specialising in precision therapies for inflammatory and fibrotic diseases, has been granted orphan drug designation from the European Medicines Agency (EMA) for FT011.
The lead drug candidate, if successful in clinical trials, will be used to treat systemic sclerosis, and has already received orphan drug designation and fast track designation from the US Food and Drug Administration (FDA) for the same condition.
Targeting a previously undruggable GPCR
FT001 is a first-in-class oral therapy, which has been designed to treat chronic fibrosis — targeting an undrugged membrane GPCR, GPR68.
The company claims that GPR68 plays a significant role in the disease pathology of systemic sclerosis, and that Phase I and IIa clinical trials have already shown promise in terms of efficacy, safety and pharmacokinetics.
Systemic sclerosis is a chronic autoimmune disease which is commonly associated with inflammation and fibrosis of the skin and internal organs. Such symptoms can hugely impact a patient's quality of life, and there are currently no treatments available for the condition.
The founder and CEO of Certa Therapeutics, Darren Kelly said: “GPR68 inhibition modulates the biological pathways causing inflammation and fibrosis to the skin in patients with systemic sclerosis. With limited treatment options available for patients with the disease, the EMA Orphan Drug Designation and FDA Orphan Drug and Fast Track Designations reflect the potential for FT011 to address a critical need for people living with this debilitating and life-threatening condition.
“These are significant validations for the company and highlight the unmet need for novel medicines to reduce inflammation and scarring in chronic fibrotic diseases, which are often progressive and can have a poor prognosis.”
Confirmatory clinical trials incoming
Certa is planning for a Phase IIb confirmatory SSc clinical trial with FT011, bringing the company closer to providing better treatment options for patients with fibrosis. It is also developing biomarkers and gene signatures to identify patients most likely to respond to treatment to ensure the best outcomes for those with fibrosis.