Dizlin

With the capital we raised in September/October, we have been able to complete both the user study for the pump and the preclinical program. We know that both projects have gone well, although we have not yet received the final reports, which we will receive shortly. During the autumn, we intensified our efforts to secure additional capital to carry out the pilot study. At the time of writing, we have an international institutional investor who says they are willing to cover about half of our investment need, which amounts to SEK 60 million. Thus, our focus is now on finding one or more strategic investors who can secure the remaining amount. However, as mentioned in the shareholder letter in September, the discussions and the due diligence process take time. We aim to close the investment round in the first quarter of 2024.

Below is a brief update:

1. Patents: Things are continued to be very promising on the patent side. In addition to the three most important markets – EU, US, and Japan – we have added markets such as Mexico, the UK, South Africa, Turkey, etc. Our active patent strategy, which aims to ensure that all significant markets worldwide are protected against patent infringement, is successful as we continuously add new countries.
2. Preclinical Study: Our preclinical study (with the aim of investigating local skin tolerance) conducted in Denmark, has recently been completed with good results. We expect to receive a draft report before the end of the year. The study is the last in the preclinical program and will be part of the New Drug Application (NDA) for the approval of Infudopa SubC.
3. Pump: As mentioned above, the development project regarding the design of the pump to be used for treatment with Infudopa SubC in outpatient care is complete. The pump has been fully validated and was used in the preclinical study mentioned above. In our second study, the so-called usability study, where the aim is to evaluate how patients and healthcare professionals handle the pump and its functions, has been completed. Here we will receive a final report during the first quarter of 2024. This report will be used as a basis for EU approval of the pump.
4. Manufacturing: Intensive work is underway to identify a pharmaceutical manufacturer, for commercial manufacturing, that can fill Dizlin’s Infudopa SubC syringes. Dizlin’s ambition is to distribute pre-filled syringes at launch, which will make it easier for both patients and healthcare professionals.
5. Registration Status: As previously communicated, Dizlin has received feedback from both the U.S. Food and Drug Administration (FDA) and the Swedish Medical Products Agency regarding Infudopa SubC. Dizlin’s planned development program, i.e., the implementation of a small pilot study of approximately 15 patients for 2 weeks and a larger tolerability study, appears to be sufficient for approval in Europe. For approval in the US, we also need to supplement with a small study on healthy volunteers – however, the FDA states that this study (as well as the larger tolerability study) can also be conducted in Europe (rather than the US), which makes it a significantly lower cost study to perform. Regarding the registration of our product Infudopa IntraV, our assumption is that only the work to ensure quality of manufacturing, i.e., to carry out a number of test batches, is required for approval in Sweden first, followed by the remaining countries in the EU. For the United States, we need to supplement, as mentioned above, with a small study on healthy volunteers, which is done simultaneously and included in the same study as SubC.

We in management and the board believe we see a glimmer of light in the investment darkness as several have shown an interest in the company. Raising capital as soon as possible is essential for the company allowing us to drive our important projects forward.

We are also optimistic about how the ongoing projects have developed and look forward with confidence to raising the capital we so badly need to carry out our projects in 2024.

A picture of our well-functioning pump is attached below.

Wishing you pleasant holidays and happy new year.

Björn Velin
CEO, Dizlin Pharmaceuticals AB

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

Björn Velin
CEO, Dizlin Pharmaceuticals AB

Gothenburg, Sweden, April 25^th, 2023 – Dizlin Pharmaceuticals AB, a research-based pharmaceutical development company with focus on diseases of the central nervous system (CNS), today announces a patent approval in the USA

Dizlin Pharmaceuticals has secured a solid patent protection concerning the innovations of Infudopa SubC and Infudopa IntraV for the treatment of advanced Parkinson’s Disease (PD) in the USA – the biggest pharma market in the world. As announced earlier, Dizlin Pharmaceuticals also has patent protection for, among others, Europe, Mexico, and Japan (which is the second biggest PD market).

“This robust patent protection, which will expire in 2039, will give us many years at the market without generic entrance and this was exactly what we had hoped for”, says Björn Velin, CEO of Dizlin Pharmaceuticals. “We have now secured a solid patent protection in the most important markets in the world – USA, Europe, and Japan – and more approved patents are likely to arrive later this year.”

This release discusses patent.  There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

For more information, please contact:
Björn Velin, CEO, Dizlin Pharmaceuticals AB
Cell phone: + 46 (0)76 879 2325, e-mail: bjorn.velin@dizlin.se

The information was released for public disclosure, through the agency of the contact person above, on April 25^th, 2023.

About Infudopa IntraV™
Infudopa IntraV™ (DIZ101) is a levodopa-carbidopa solution aimed to be administered intravenously using infusion pumps to inpatients who cannot receive oral administration of levodopa when being the subject of surgery with general anesthesia.

About Infudopa SubC™
Infudopa SubC™ (DIZ102) is a levodopa-carbidopa solution intended for outpatient treatment. Used with a portable twin pump enabling continuous mixing prior to infusion, Infudopa SubC™ is aimed as monotherapy for subjects who experience moderate to severe motor fluctuations when receiving oral administration of levodopa. When reaching the patient, Infudopa SubC™ displays a physiologically acceptable pH which also seems to optimize efficient levodopa uptake. The shelf life is 36 months in refrigerator and at least three months at room temperature, which would represent a significant logistic advantage for patients, e.g., when traveling.

About Parkinson’s disease
Parkinson´s disease (PD) is a serious neurodegenerative disease afflicting more patients than multiple sclerosis, amyotrophic lateral sclerosis, muscular dystrophy, and myasthenia gravis combined. Characterized by bradykinesia (poverty of motion), tremor, and muscular rigidity, and caused by degeneration of neurons using dopamine as transmitter, PD is a chronic and progressive condition, with a prevalence of 1% over the age of 60 and 3% of those over 75.

About Dizlin Pharmaceuticals
Dizlin Pharmaceuticals AB is a privately held Swedish research-based pharmaceutical development company with focus on diseases of the central nervous system in general and on developing improved treatment for advanced stages of Parkinson’s disease in particular. The company conducts research in collaboration with researchers at the University of Gothenburg and Linköping University in Sweden.

The company has developed a new patented method for treatment of advanced stages of Parkinson’s disease. Dizlin Pharmaceuticals has two products in late phase development stage. The first – Infudopa IntraV™ – is administered intravenously to minimize risks associated with surgery on patients with Parkinson’s disease. The second – Infudopa SubC™ – is administered as a continuous subcutaneous infusion by means of a portable pump (similar to insulin infusion for diabetes).

Gothenburg, Sweden, September 7, 2022 – Dizlin Pharmaceuticals AB, a research-based pharmaceutical development company with focus on diseases of the central nervous system (CNS), announces that an article has been published in Neurology®, from the American Academy of Neurology®, describing data from the company’s IPO-001 pharmacokinetic cross-over study.   

• In a pharmacokinetic cross-over study comprising 18 evaluable subjects with advanced Parkinson´s disease, levodopa/carbidopa solutions with a pH of 5.5 were produced by continuous buffering shortly prior to intravenous (DIZ101) or subcutaneous (DIZ102) administration.
• During the 16h of infusion, both DIZ101 and DIZ102 displayed plasma levels of levodopa comparable to those obtained by means of dose-adjusted intestinal administration of a levodopa/carbidopa gel (Duodopa, LCIG) – predefined bioequivalence aims of the study were hence met.
• The bioavailability of levodopa was 100% with subcutaneous administration of DIZ102 and 80% with intestinal administration of LCIG.
• Skin-related side effects were generally absent or mild.

“The outcome shows that subcutaneous administration of a continuously buffered levodopa solution could be a feasible technique to safely and rapidly obtain high and stable levodopa levels in patients with Parkinson´s disease”, says principal investigator Filip Bergquist, MD, senior consultant in neurology and professor of pharmacology.

“The data were those that we had hoped for,” says Björn Velin, CEO of Dizlin Pharmaceuticals. “The results suggest that DIZ102 (Infudopa SubC™), administered by means of a portable twin pump, may serve as a levodopa/carbidopa monotherapy for patients requiring high levodopa levels but experience motor fluctuations when receiving oral administration. The rapid uptake of levodopa from the subcutaneous tissue would enable considerable flexibility in dosing, which we also regard as an important advantage. Unlike intestinal administration of a levodopa/carbidopa gel, Infudopa SubC™ requires no surgery and displays considerable room temperature stability prior to mixing.”

The article in Neurology is accessible for free at:  https://n.neurology.org/content/99/10/e965

This release discusses investigational uses of products in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.

For more information, please contact:
Björn Velin, CEO, Dizlin Pharmaceuticals AB
Cell phone: + 46 (0)76 879 2325, e-mail: bjorn.velin@dizlin.se

The information was released for public disclosure, through the agency of the contact person above, on September 7, 2022.

About Infudopa IntraV™
Infudopa IntraV™ (DIZ101) is a levodopa-carbidopa solution aimed to be administered intravenously using infusion pumps to inpatients who cannot receive oral administration of levodopa when being the subject of surgery with general anesthesia.

About Infudopa SubC™
Infudopa SubC™ (DIZ102) is a levodopa-carbidopa solution intended for outpatient treatment. Used with a portable twin pump enabling continuous mixing prior to infusion, Infudopa SubC™ is aimed as monotherapy for subjects who experience moderate to severe motor fluctuations when receiving oral administration of levodopa. When reaching the patient, Infudopa SubC™ displays a physiologically acceptable pH which also seems to optimize efficient levodopa uptake. The shelf life is 36 months in refrigerator and at least three months at room temperature, which would represent a significant logistic advantage for patients, e.g., when traveling.

About Parkinson’s disease
Parkinson´s disease (PD) is a serious neurodegenerative disease afflicting more patients than multiple sclerosis, amyotrophic lateral sclerosis, muscular dystrophy, and myasthenia gravis combined. Characterized by bradykinesia (poverty of motion), tremor, and muscular rigidity, and caused by degeneration of neurons using dopamine as transmitter, PD is a chronic and progressive condition, with a prevalence of 1% over the age of 60 and 3% of those over 75.

About Dizlin Pharmaceuticals
Dizlin Pharmaceuticals AB is a privately held Swedish research-based pharmaceutical development company with focus on diseases of the central nervous system in general and on developing improved treatment for advanced stages of Parkinson’s disease in particular. The company conducts research in collaboration with researchers at the University of Gothenburg and Linköping University in Sweden.

The company has developed a new patented method for treatment of advanced stages of Parkinson’s disease. Dizlin Pharmaceuticals has two products in late phase development stage. The first – Infudopa IntraV™ – is administered intravenously to minimize risks associated with surgery on patients with Parkinson’s disease. The second – Infudopa SubC™ – is administered as a continuous subcutaneous infusion by means of a portable pump (similar to insulin infusion for diabetes).

PR 20220907 DIZ101 Neurology