Stablepharma has announced dosing of the first participant in a Phase IIb clinical trial of SPVX02, the company's thermostable tetanus-diphtheria (Td) booster vaccine.
This trial follows Stablepharma’s positive Phase I results, published in eClinicalMedicine in August.
SPVX02 is a "fridge-free" lyophilised reformulation of Tetadif, designed to remain stable at temperatures up to 40°C and be resistant to freezing.
The company developed it using its proprietary StablevaX technology, aiming to commercialise the vaccine and eliminate dependence on costly, complex cold-chain infrastructure.
The new Phase IIb clinical trial is a randomised, single-blind, non-inferiority study enrolling 160 healthy adults.
The company said it expects SPVX02 to generate post-boost immune responses non-inferior to Tetadif, the licensed WHO-prequalified tetanus-diphtheria originator vaccine.
The study will also evaluate SPVX02's safety and tolerability.
Özgür Tuncer, CEO of Stablepharma, said: “The publication of our Phase I data in eClinicalMedicine provided independent validation of the science underpinning SPVX02."
"The launch of this Phase IIb study is the final critical step on the pathway towards commercialisation."
He added that the company planned to extend the technology to other partner companies' vaccines and pharmaceutical products as part of its broader strategy.
We believe StablevaX can help pharmaceutical partners develop fridge-free versions of vaccines, biologics and other temperature-sensitive medicines to strengthen healthcare supply chains worldwide.
Dr Karen O’Hanlon, CEO of Stablepharma, added: "For many vaccines and medicines, cold-chain storage has long been accepted as
unavoidable."
This study is designed to generate the clinical evidence needed to advance SPVX02 towards commercialisation while demonstrating the broader potential of the platform to transform how temperature-sensitive medicines are stored and distributed worldwide.
