Orphan Therapeutics Accelerator has expanded its development network for ultra-rare diseases, adding clinical, manufacturing, regulatory and access partners to support stalled therapy programmes.

Orphan Therapeutics Accelerator (OTXL) has expanded its Orphan ClinDevNet network through the addition of four new partners, strengthening its infrastructure for the development and delivery of ultra-rare disease therapies.

The non-profit biotech works to identify and advance shelved or stalled clinical-stage treatments for ultra-rare conditions, where traditional development models are often constrained by small patient populations and high development costs.

The latest expansion adds capabilities across clinical trial delivery, manufacturing, regulatory strategy and patient access, aiming to support the progression of multiple programmes through to approval and eventual patient access.

The new partners include OPIS, Uniphar, SK pharmteco and TMC Pharma, each contributing specific expertise across the development pathway.

OPIS will provide global clinical development and trial execution capabilities across Europe, Asia and the Americas, supporting multinational studies and complex rare disease trial design.

Uniphar will contribute expanded access and healthcare logistics services, supporting patient access pathways in markets where treatment distribution and coordination can present challenges.

SK pharmteco will provide US-based viral vector manufacturing capacity, supporting advanced therapy programmes requiring specialist production and scale-up capabilities.

TMC Pharma will contribute regulatory strategy, market access and clinical development support across the UK and Europe, with a focus on aligning regulatory planning earlier in the development process.

The network expansion is intended to create a more coordinated model for progressing ultra-rare disease programmes, integrating clinical development, manufacturing and access planning through a shared partner ecosystem.

Craig Martin, chief executive officer and co-founder of Orphan Therapeutics Accelerator, said: “Rare diseases require more decentralised, efficient and outsourced solutions than traditional biopharma development models were designed to support. By expanding this network, we are strengthening our ability to move multiple therapies forward more efficiently and bring more treatment options to highly dispersed patient populations around the world.”

OTXL said the expanded ClinDevNet model is designed to reduce development bottlenecks by aligning specialist partners early in the process and enabling more flexible pathways from development through to patient access.