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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - StayAble (A non-surgical and long-lasting treatment to substantially reduce back pain)

Teaser

Summary

Stayble Therapeutics is developing STA-363; a truly innovative, non-surgical product to permanently alleviate chronic low back pain. STA-363 is a first-in-class, patent pending, injectable medicinal product to stabilize degenerated discs. The product irreversibly transforms the spinal disc center to connective tissue. The target patient population for STA-363 includes patients suffering from discogenic back pain with moderate disc degeneration not responding adequately to at least 6 months of conservative treatment.

The main objective of the project was to gain a better understanding of the market potential and support business development through partner identification and mapping.

Work performed

Stayble Therapeutics AB has conducted a feasibility study within the project StayAble.

Main results achieved and potential impact
- The patient population was analyzed based on the extensive patient recruitment funnel to phase IB and the careful pre-screening work. This gave Stayble a precise understanding of who the patients are and how to find them for the next clinical study and commercialization. Social media proved most effective in reaching and recruiting patients and the use of social media will be critical for the recruitment to the coming trial.
- Potential co-development and commercialization partners were identified and mapped during the project. A partnering plan including target partner companies, conference and communication plan was developed. The plan has been set in action with the aim to investigate the potential to partner already before entering phase IIB.
- The financial viability of STA-363 was assessed in an rNPV model (risk-adjusted Net Present Value). Critical assumptions on market penetration, price of product, cost of clinical development and time to market were defined. The model was then qualified with industry expertise. The model has given Stayble the confidence and the tool to discuss the projections with investors and potential partners. In addition, Stayble has been able to develop rather accurate budgets for conducting clinical phase IIB and the phase III program.
Ultimately the business plan has been updated with project results and finalized, preparing Stayble for partnering, series A financing and applying to SME phase II.

Final results

The product vision of STA-363 is to become the new standard of care for patients with chronic discogenic cLBP. Stayble Therapeutics is currently finalizing a clinical phase I study in 15 patients with cLBP. Patient enrolment was completed in August 2018, and results are expected during Q1, 2019.

The company is now preparing for a phase IIB proof of concept and dose determination study in approximately 100 patients. The primary objective of the study is to show a statistically significant (p â‰¤0.1 at a power of 80%), and clinically relevant decrease in back pain at 6 months follow-up. After successful completion of the phase IIB study Stayble plans to enter phase III studies together with a commercial partner.