During the spring, Dizlin Pharmaceuticals has continued to focus on our prioritized projects: patent, pump development, preclinical pilot study, and – not least – further exchange with FDA and Swedish MPA
The development program for the pump that will be used for treatment Infudopa SubC™ in outpatient care is now ready and the pump has been successfully tested in a pilot preclinical study. The validation process required is ongoing with the aim to submit for CE marking by the end of this year. We are very pleased with our collaboration with the pump developer FDE and highly satisfied with the result.
We have received encouraging feedback from the US authorities (FDA) regarding SubC. FDA accepted our planned road for approval which hence is now settled. As planned, it will be restricted to a small pharmacokinetic study in healthy volunteers and a safety study in patients with Parkinson´s disease. FDA accepted that this study be conducted in Europe only, which will reduce the costs significantly as compared to if we would have to include trial centers also in US.
We also had a scientific advice meeting with the Swedish MPA (Läkemedelsverket) again with encouraging outcome. The agency hence agreed with our suggestion that a small preclinical study and the safety study in patients mentioned above would be sufficient for getting a marketing approval in Sweden/EU.
It may be added that we also plan to conduct small pilot study in patients with Parkinson´s disease to make sure that everything pump-related is working as planned before starting the larger safety study. This pilot study is however not required by the authorities.
Regarding our patent, Dizlin is very happy to announce that we have now got an approved patent for US (please see press release 25 April) which is the most important market in the world. As already mentioned in a previous newsletter, Dizlin has obtained approval of similarly broad patents application for Infudopa SubC™ as well as Infudopa IntraV™ in EU, Japan (second biggest market in the world), South Africa and Mexico.
As previously announced, the excellent pharmacokinetic data from the IPO-001 study – showing Infudopa SubC to produce high and even levels of levodopa – have been published in a highly ranked medical journal, Neurology, where our paper was accompanied by a supportive editorial comment. In a second publication based on the same study, which will be submitted to an international journal before the end of June, the effect of the treatment on Parkinson symptoms will be presented.
The board of Directors of Dizlin has decided to initiate a capital raise process, a “Pre-IPO”, together with Västra Hamnen Corporate Finance, which has a long experience and a good track record; they recently received a prize from Affärsvärlden, a leading Swedish business magazine, for best IPO 2022 in Sweden. We will update all shareholders with additional information related to this process shortly.
The main objective for raising capital is to secure a continuation of our development program:
- Completion of the CMC development (i.e., the mandatory activities ensuring that a new product may be safely manufactured).
- Submission of a registration application to the EMA for Infudopa IntraV™
- Finalization of the pump validation process (including a usability study).
- Completion of the above-mentioned preclinical safety study.
- The above-mentioned pilot study in out-patients with Parkinson’s disease – where Infudopa SubC for the first time will be administered using the novel pump – the purpose of which is to ensure the feasibility of the trial design planned for the larger tolerability study.
These activities will take us a long way in our development plan, where the results expected from the pilot study – that Infudopa SubC indeed is an attractive option for patients in advanced stages of Parkinson´s disease – are likely to make Dizlin even more attractive for investors and potential buyers.
Wishing you a nice summer
CEO, Dizlin Pharmaceuticals AB