Digna will look for a different partner to conduct development from Phase IIb onward.
Digna Biotech regains full rights to Disitertide (P144), a topical formulation of a peptide-based therapy for skin conditions, from ISDIN. According to their agreement, potential revenues will be shared between Digna and ISDIN. Disitertide has completed a Phase IIa trial, and EMA has provided details for setting up a Phase IIb study. Digna plans on pursuing further development through a different partnership.
Disitertide has orphan drug designation to treat systemic sclerosis and localized scleroderma from EMA and FDA. It is a TGF-β1 (transforming growth factor-beta 1) inhibitor that was jointly developed with ISDIN until completion of an open-label extension (OLE) study that followed a Phase IIa trial in skin systemic sclerosis.
The proof-of-concept trial recruited 56 patients with skin fibrosis in 17 hospitals in European countries (Germany, Hungary, Italy, Poland, Spain, and the U.K.). All patients were treated with Disitertide (P144) and placebo under double-blind conditions. Skin improvement was perceived by 42% of the patients in the Disitertide-treated arm, while 18% noticed improvement in the placebo-treated arm, Digna reports.
Patients who completed the clinical trial were invited to participate in the OLE study, treating up to 10% of their body surface. More than 80% of patients perceived an improvement in the treated skin after six months on Disitertide, the firm says.
Based on these results, the EMA gave protocol advice last year for the design of a Phase IIb trial. “We have two big advantages: firstly, the investigators participating in the Phase IIa trial who are willing to continue with the development of the product after the analysis of the previous trial results, and, secondly, the patients participating in the open-label extension trial who gave us some very good feedback, and they are also willing to continue to participate in the new Phase IIb trial,” Digna Biotech’s CEO Pablo Ortiz said.
Systemic sclerosis or scleroderma is a multisystemic disorder characterized by the excessive synthesis and deposition of extracellular matrix proteins that result in the fibrosis of skin and visceral organs including gastrointestinal tract, lungs, heart, and kidneys. TGF-β1 overexpression is one of the key factors in the development of this disease.
Digna believes that TGF-β1 block could be an important factor to improve fibrosis in different organs and therefore ameliorate various sclerotic conditions. The company is also investigating other formulations of Disitertide in additional indications such as pulmonary and cardiac fibrosis, retinal macular degeneration, and prosthetic implant-induced fibrosis.