Dizlin has during the autumn continued to work on prioritized projects according to the updated project plan. Progress has been made with pharmaceutical development, pump development and the regulatory application process.
The extensive work with Chemistry Manufacturing and Controls (CMC) – specifically the analyses and documentation required for us to be able to submit a registration application for Infudopa IntraV™ at the end of next year – has gone well and is on schedule.
The development program for the pump which will be used for treatment Infudopa SubC™ in outpatient care is in the final phase. A working prototype has been developed and we will have a number of pumps for use in clinical studies early next year. We are very satisfied with the pump thus far as well as the collaboration with the pump development partner FDE.
Extensive work to compile data related to the Pre-IND for Infodopa SubC™ has also recently been completed. The Pre-IND is the documentation that the FDA (US Food and Drug Administration) will use to be able to provide us guidance on what is required for an approval in the USA. A response from the FDA is expected at the beginning of March 2023.
As previously announced, Dizlin has received a broad patent approval for Infudopa in the EU. Some time ago we also received the news that we have been granted patents in Mexico and Japan, which is very positive, as Japan is the world’s second largest market for Parkinson’s disease. We do not yet have a granted patent in the United States, but based on the latest opinion from the patent authority, there is a high likelihood that we will be granted strong patent protection in the United States. We see the progress related to our intellectual property as very positive.
Another welcome piece of news is that the results of the important pharmacokinetic study for both Infudopa SubC™ and Infudopa IntraV™ – study IPO-001 – were published in the respected journal Neurology on 6 September, which also resulted in a positive editorial in the same issue.
Despite this positive news, there are clouds of concern related to a number of well-known external factors – uncertain macro situation with rising inflation and interest rates, and a falling stock market as a result, make it increasingly difficult to raise capital. We continue to work actively with the planned capital raise and have contact with strategic investors, funds and private investors.
Our ambition is to raise a total of SEK 100 million.
The capital requirement relates to the implementation of the following activities:
- Completion of the CMC development and submission of a registration application to the EMA for Infudopa IntraV™
- Completion of the pre-clinical work for both Infudopa SubC™
- The performance of the pharmacokinetic study on healthy volunteers that is required by the FDA for both Infudopa SubC™ and IntraV™
- Submission of a registration application to the FDA for Infudopa IntraV™
- The implementation of a small pilot study with the newly developed pump in patients with Parkinson’s disease for Infudopa SubC™
SEK 100 million would take us a long way in our development plan – all the way to the submission of registration applications for Infudopa IntraV™ and up to the initiation of the tolerability study for Infudopa SubC and we continue to work actively to raise this capital.
Wishing you a Merry Christmas and a Happy New Year 2023
CEO, Dizlin Pharmaceuticals AB