A novel treatment of acne vulgaris based on anti-biofilm protein
| Reference number | |
| Coordinator | Vakona AB - UMEÅ BIOTECH INCUBATOR AB |
| Funding from Vinnova | SEK 293 750 |
| Project duration | June 2020 - January 2021 |
| Status | Completed |
| Venture | Innovative Startups |
| Call | Innovative Startups step 1 spring 2020 |
Important results from the project
The purpose of this project was to validate performed and planned activities from a regulatory perspective in connection with the preparation and execution of a scientific advice meeting with the Swedish Medical Products Agency (MPA). The project goal was to obtain a robust project plan that reduces the risk of serious complications and delays later in product development.
Expected long term effects
The activities performed during the project have resulted in a robust project plan. A project plan with validated activities will give us support in early drug development to plan and prepare for first-in-human clinical trial. Validated activities will also give us support in discussions with investors to justify planned activities and capital need. Next steps for the project will be: Outline formal study protocols for preclinical studies and clinical phase I/IIa. Outline a plan for drug product formulation (ointment/cream/lotion), packaging and fill-finish.
Approach and implementation
The scientific advice meeting was initially planned to be performed in Nov 2020. Due to a delay in the preparations and fully booked meeting slots at the MPA, the meeting was postponed to Jan 15, 2021. Preparations was performed in collaboration with consultants that has competence within the regulatory field. This was very helpful since we had a high workload and questions could be answered quickly. The consultant also helped us to identify any lack of important information. The meeting was time-restricted to 1.5 h, thus the preparations was very important for the outcome of the meeting.