Paradigm Biopharmaceuticals receives critical approvals and feedback from agencies to progress MPS

Paradigm Biopharmaceuticals Ltd (ASX:PAR) has achieved a number of key approvals required to progress investigation into the use of its core drug Pentosan Polysulfate Sodium (PPS) in the treatment of the rare disease mucopolysaccharidosis (MPS).

Firstly, the company has gained ethics approval for its proposed pilot study for the ultra-rare Orphan disease Mucopolysaccharidosis Type 1 (MPS-1).

The ethics approval is validation from the medical/scientific community that PPS may provide benefit to patients who continue to experience this unmet need.*EMA approval*

Paradigm has also received approval from the European Medical Agency (EMA) for its Orphan designation application for MPS-VI.

Such approvals from the EMA can take up to 90 days, however, Paradigm received a decision on Day 60 of the process.

Positive feedback has been received from a Parallel Scientific Advice (PSA) meeting with the Federal Drug Administration (FDA) and EMA, where the company received clarification on the design of the clinical program and feedback on the regulatory pathway for its submission for a Phase 2/3 Clinical trial in MPS-VI.