A Phase I/II dose-ranging, randomized controlled clinical trial has been completed on 34 patients, in five clinical sites, aiming to investigate the safety of our novel TRS01.
To reach this stage, several main milestones were achieved from the beginning of the project to the end of the period covered by the report:
1. Production of GMP material of the Drug Substance in sufficient quantities to allow production of sufficient drug product to cover both the requirements for the clinical trial as well as the requirements for stability studies.
2. Successful production of the GMP Drug Product – eye drops (4 batches – 3 active dosages and placebo).
3. Stability testing of the clinical batches of the Drug Substance and Drug products.
4. Submission and approval of all the regulatory dossiers required in order to initiate the clinical trial.
5. Successful recruitment of sites, PIs, patients, and streamlined clinical management of the trials.
6. At the end of the trial, a Clinical Study Report was issued (CSR) and submitted as deliverable.
Importantly, we managed to carry out this clinical trial despite the COVID-19 restrictions and difficulties.
In addition, we achieved another important milestone: receiving an Orphan Drug Designation status from the EMA, providing important commercial and R&D incentives for the program with benefits such as extended market exclusivity, tax reliefs and shorter time to market.
We have also achieved already a few milestones for our future plans to initiate phase-3 trials:
Completion of study design for phase-3 pivotal trials in non-infectious anterior uveitis including patients with uveitic glaucoma
• Final study protocol and approval by ethical committee.
• Regulatory submissions to the EMA and FDA
• Recruitment of first 20 sites.
In addition, two new patent applications have been filed to strengthen the IP protection of our novel compound, and, in collaboration with uveitis experts, we have published a scientific article about a new visual analogue grading scale to assess uveitis.
