Drug Development Strategy: The Treeway Story

The valley of death is often mentioned when talking about drug development. It’s the place where most biotech companies do not survive. Not Treeway, a small Dutch biotech company that made it to the other side.

TreewayA drug development strategy is a well-designed and dynamic process, which is performed by most companies in stages. From pre-clinical all the way to registration, a well-organized set of action plans and visionary interpretations are used.

Treeway teamed up with 3D-PharmXchange to have their studies development program of their lead product TW001 run in parallel or performed in combination to save time and money. 3D-PharmXchange calls this Smart Trial Design.

Working with 3D-PharmXchange gave Treeway access to experts in all core disciplines of drug development: CMC, Regulatory Affairs, Non-Clinical and Clinical and project management.

3D-PharmXchange was able to do what most small biotech can’t: develop a plan that covers the entire drug-development pipeline.
Treeway has worked with 3D-PharmXchange on drug development since the beginning. To our knowledge, establishing a combined management team of scientists, entrepreneurs and patients was unique.

3D-PharmXchange developed the company’s regulatory, non-clinical and clinical strategy, validated the plan with the EMA and FDA, and took care of coordination and guidance in the early clinical development program. Finally, 3D-PharmXchange produced a patented oral formulation of edaravone at a time when no one thought it was possible.

Last week Treeway made a significant step forward in the development of the first viable treatment for ALS sufferers.

Treeway announced that FNP122 (previously TW001) has entered clinical stage phase III with the start of the ADORE project. This is thanks to a licensing arrangement between Treeway and Ferrer (ALS Deceleration study with Oral Edaravone). Ferrer will now evaluate FNP122’s safety and efficacy in delaying disease progression in ALS patients in large-scale double-blind placebo-controlled clinical research.

Treeway made it to the other side.

Going from bench to the patient’s bedside is the dream of any scientist. Working smarter can make this goal a reality. Having a clear plan and guidance from first tests all the way to the final drug product is crucial. Being able to combine CMC, Regulatory Affairs, Non-Clinical and Clinical is vital.
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