Periodic Reporting for period 1 - OPERAS (Opioid-free Pain relief for Enhanced Recovery After Spine fixation surgery)
Reporting period: 2023-04-01 to 2024-03-31
There is a troubling lack of effective pain treatments after major surgery. Especially after musculoskeletal procedures, patients experience debilitating pain now treated with opioids. Opioids provide insufficient pain relief, have many toxic side-effects, and are highly addictive. Pain and opioid-related side-effects impede early mobilisation and recovery and are the primary reason for extended hospital stays.
SentryX is developing revolutionary drug delivery technology to extend the effects of a well-established local pain blocker called bupivacaine. Its initial use case in spine fixation surgery, Bupi-Ring, delivers bupivacaine directly to the surgical site for more than 72 hours without changing the existing surgical workflow. Non-opioid local pain relief in this critical early phase of recovery will promote early mobilisation, shorten hospital stays, prevent complications, and save costs.
The goal of this project is to demonstrate Bupi-Ring’s safety in humans for the first time. To this end, SentryX will conduct an open-label Phase Ib clinical trial in two European countries. In parallel, SentryX will finalise its market access strategy and make preparations with instrumental and financial support from strategic partners. Project management and stakeholder engagement are also a part of the project.
SentryX is developing revolutionary drug delivery technology to extend the effects of a well-established local pain blocker called bupivacaine. Its initial use case in spine fixation surgery, Bupi-Ring, delivers bupivacaine directly to the surgical site for more than 72 hours without changing the existing surgical workflow. Non-opioid local pain relief in this critical early phase of recovery will promote early mobilisation, shorten hospital stays, prevent complications, and save costs.
The goal of this project is to demonstrate Bupi-Ring’s safety in humans for the first time. To this end, SentryX will conduct an open-label Phase Ib clinical trial in two European countries. In parallel, SentryX will finalise its market access strategy and make preparations with instrumental and financial support from strategic partners. Project management and stakeholder engagement are also a part of the project.
WP1:
Activities:
SentryX has initiated its first-in-human clinical trial for Bupi-Ring. The trial consists of two cohorts of six patients. The first cohort undergoes instrumented spine surgery with 4 pedicle screws and 4 Bupi-Rings. The second cohort receives 6 pedicle screws and 6 Bupi-Rings. Each cohort contains three patients undergoing open procedures (single surgical wound) or minimally invasive surgeries (separate incisions for each screw) with Bupi-Ring. The main outcome is whether the measured concentrations of bupivacaine in the blood remain below known toxic thresholds. Additional safety and preliminary efficacy outcomes are also included in the study. Positive results from this study will serve as the basis for a clinical trial application for a single pivotal trial in approximately 200 patients, which will be essential for the approval of Bupi-Ring in Europe and the United States.
Main achievements so far:
The first cohort of six patients has been fully included in the study. The data for these patients has been reviewed by an independent data safety monitoring board (DSMB), who have recommended to proceed to the second cohort. In the second cohort, 3/3 patients have undergone minimally invasive surgeries. The inclusion of patients for the open procedures is currently ongoing.
WP2:
Activities:
To formulate and initiate a definitive market access strategy, SentryX will explore strategic partnerships for the commercialisation and distribution of Bupi-Ring in Europe and the United States. Because Bupi-Ring is universally compatible with commercially available pedicle screws, several scenarios can be conceived: exclusive deals with large pharmaceutical or MedTech companies, or non-exclusive models where SentryX directly supplies hospitals whilst outsourcing distribution and sales.
Main achievements so far:
The funding round has been initiated. Prior to the round, SentryX already had several discussions with various large MedTech companies and VCs. Now, the investor deck has been sent out and the data room largely prepared. Several discussions have already taken place with leading MedTech companies, with positive initial feedback. A definitive position is yet to be taken by these companies. Contacts with Venture Capital firms and Family offices have been initiated, from whom an initial response is expected soon.
SentryX has previously presented its scientific evidence at two global conferences. The initial results of the Phase Ib clinical trial will also be presented at several international conferences in the coming year.
WP3:
Project management:
The objectives of project management are to ensure that the project itself runs smoothly, effectively and on budget, to provide frequent progress updates, and to keep professional and societal stakeholders engaged and aligned. Progress reports will be provided to the funding body for the grant component of the EIC Accelerator. This work package also includes operational expenses, including in-house consultancy and intellectual property protection.
Main achievements so far:
The first progress meeting has been concluded successfully, with the project on track and on budget. As the second 12-month progress meeting is coming up, the project is still on track and expected to be completed well within the proposed timeframe.
Activities:
SentryX has initiated its first-in-human clinical trial for Bupi-Ring. The trial consists of two cohorts of six patients. The first cohort undergoes instrumented spine surgery with 4 pedicle screws and 4 Bupi-Rings. The second cohort receives 6 pedicle screws and 6 Bupi-Rings. Each cohort contains three patients undergoing open procedures (single surgical wound) or minimally invasive surgeries (separate incisions for each screw) with Bupi-Ring. The main outcome is whether the measured concentrations of bupivacaine in the blood remain below known toxic thresholds. Additional safety and preliminary efficacy outcomes are also included in the study. Positive results from this study will serve as the basis for a clinical trial application for a single pivotal trial in approximately 200 patients, which will be essential for the approval of Bupi-Ring in Europe and the United States.
Main achievements so far:
The first cohort of six patients has been fully included in the study. The data for these patients has been reviewed by an independent data safety monitoring board (DSMB), who have recommended to proceed to the second cohort. In the second cohort, 3/3 patients have undergone minimally invasive surgeries. The inclusion of patients for the open procedures is currently ongoing.
WP2:
Activities:
To formulate and initiate a definitive market access strategy, SentryX will explore strategic partnerships for the commercialisation and distribution of Bupi-Ring in Europe and the United States. Because Bupi-Ring is universally compatible with commercially available pedicle screws, several scenarios can be conceived: exclusive deals with large pharmaceutical or MedTech companies, or non-exclusive models where SentryX directly supplies hospitals whilst outsourcing distribution and sales.
Main achievements so far:
The funding round has been initiated. Prior to the round, SentryX already had several discussions with various large MedTech companies and VCs. Now, the investor deck has been sent out and the data room largely prepared. Several discussions have already taken place with leading MedTech companies, with positive initial feedback. A definitive position is yet to be taken by these companies. Contacts with Venture Capital firms and Family offices have been initiated, from whom an initial response is expected soon.
SentryX has previously presented its scientific evidence at two global conferences. The initial results of the Phase Ib clinical trial will also be presented at several international conferences in the coming year.
WP3:
Project management:
The objectives of project management are to ensure that the project itself runs smoothly, effectively and on budget, to provide frequent progress updates, and to keep professional and societal stakeholders engaged and aligned. Progress reports will be provided to the funding body for the grant component of the EIC Accelerator. This work package also includes operational expenses, including in-house consultancy and intellectual property protection.
Main achievements so far:
The first progress meeting has been concluded successfully, with the project on track and on budget. As the second 12-month progress meeting is coming up, the project is still on track and expected to be completed well within the proposed timeframe.
The preliminary results of the Phase Ib clinical trial look reassuring. They have been discussed with relevant KOLs, who responded very positively. They believe that sustained non-opioid local pain relief will meaningfully accelerate recovery after spine surgery.
To substantiate the added value of Bupi-Ring in the clinical setting, a large multicenter single pivotal trial will be performed after the project has concluded. The results of this study will be discussed with regulatory authorities to obtain market approval in Europe and the United States.
In collaboration with one or several strategic partners, Bupi-Ring will be commercially launched, distributed, and sold in these regions. Healthcare payers will be engaged during/after the single pivotal trial to discuss opportunities for reimbursement. An early Health Technology Assessment is underway to assess the potential added value of Bupi-Ring and help guide these discussions.
To substantiate the added value of Bupi-Ring in the clinical setting, a large multicenter single pivotal trial will be performed after the project has concluded. The results of this study will be discussed with regulatory authorities to obtain market approval in Europe and the United States.
In collaboration with one or several strategic partners, Bupi-Ring will be commercially launched, distributed, and sold in these regions. Healthcare payers will be engaged during/after the single pivotal trial to discuss opportunities for reimbursement. An early Health Technology Assessment is underway to assess the potential added value of Bupi-Ring and help guide these discussions.