Decoderma and Sartar received orphan-drug designations


Mar 31 2023

Orphan drug designation, FDA, EMA, alumni, SPARKee, SPARK Finland, Sartar Therapeutics, DecoDerma

Finnish SPARKee Decoderma and alumni Sartar Therapeutics have announced recently fantastic news regarding their progress in drug development process.

Orphan drug status is assigned to a medicine intended for use against a rare condition. The medicine must fulfil certain criteria for designation as an orphan medicine so that it can benefit from incentives such as protection from competition once on the market.

Two months ago Decoderma was granted an orphan-drug designation by FDA for their intended drug for lethal rare disease epidermolysis bullosa (EB). They had received a bit earlier orphan-drug designation from EMA. Their molecule is a recombinant, multi-functional fusion protein that has both a targeting peptide (tCRK peptide) for a delivery to normal skin and skin wounds and Decorin (DCN) anti-inflammatory and anti-fibrotic protein as an active therapeutic component. The team has demonstrated the best-in-class position in the lethal, pre-clinical disease model of EB.

On yesterday Sartar Therapeutics announced in LinkedIn that they have been granted an orphan-drug designation from EMA for their cancer therapy (SAR001) on soft tissue sarcomas.  The company is developing a new precision cancer treatment, SAR001, for soft tissue sarcomas, specifically targeting phosphodiesterase 3 -protein expressing tumours. SAR001 is based on drug reformulation and repositioning of anagrelide, and has a long-acting profile that shows superior pharmacokinetic properties over oral administration, making it better tolerated and more convenient for use in therapy.

SPARK Finland and our European network congratulates both teams for fantastic work and achieving remarkable milestones! The journey continues!