DIGNA BIOTECH

P144

P144 is a 14-mer peptide with inhibitor activity over Transforming Growth Factor beta (TGF-b), its sequence derives from TGF-b type III receptor (Betaglycan). This peptide binds and block the biological activity of the cytokine Transforming Growth Factor beta (TGF-b). This cytokine has multiple and potent biological effects over, cell growth regulation, immunemodulation, angiogenesis, fibrogenesis, and tumor development among others. One of the most characteristic effects of TGF-b is based on its role over the induction of collagen and other extracellular matrix component deposition, which characterized fibrotic processes related with several pathologies. P144 has shown excellent results in preclinical animal models as an antiprofibrotic compound, as shown in published results with chronic liver damage, cardiac fibrosis and scleroderm. Thus, P144 shows a suitable profile to develop therapies to treat several diseases related with fibrogenic processes. Some examples of these pathologies are scleroderma, idiopathic lung fibrosis, renal insufficiency, cardiac fibrosis, liver cirrhosis, scars, keloids, corneal opacity, etc. Fibrosis is the key factor of local (dermal) symptoms of systemic diseases like systemic sclerosis. At the moment there are no available, efficient drugs with proved inhibitory effect over fibrosis, thus the availability of a product with clear and specific antifibrotic activity could significantly improve the survival and life quality of many patients.

Based on preclinical results, a topical formulation has been co-developed by DIGNA BIOTECH and ISDIN (a leading pharmaceutical laboratory in dermatological field in Spain) for cutaneous manifestation of systemic sclerosis. P144 has concluded Phase IIa clinical trial with positive results that justify the current design preparation of the pivotal clinical trial prior agency registration to achieve patient accessibility.

Digna Biotech is applying wide resources in the pharmacological development of systemic administration of P144 to generate new clinical indications and pharmaceutical formulations based on this antifibrotic, antitumoral and immunemodulator peptide.