The year was marked by continued positive development of Dizlin’s innovative potential treatments for late stages of Parkinson´s disease and we secured financing for the upcoming steps in development. We can look back with pride over a year marked by advances in our efforts to fulfill our ambition: to improve the quality of life for Parkinson patients with late-stage complications, such as shifts in motor function from immobility to involuntary movements.
It is satisfying to announce that we during the last quarter successfully managed to secure financing that enables us to continue our journey to create value for patients, shareholders, and society at large. Dizlin Pharmaceuticals has two potential products containing levodopa-carbidopa solutions in late development stage. The first, Infudopa SubC™, is a treatment for reducing motor complications of Parkinson’s disease via continuous subcutaneous infusion administered by a portable pump (similar to insulin infusion for diabetes). The second, Infudopa IntraV™, is administered intravenously to minimize risks associated with surgery on patients with Parkinson’s disease.
Another important milestone was finalizing the partnership for the upcoming commercial production of the portable pump, which is required for the administration of Infudopa SubC™. A clinical study has shown that our product can yield high and even levels of levodopa which is a prerequisite for being able to provide Infudopa SubC™ as a monotherapy. Infudopa SubC™ can be expected to provide at least the same efficacy as the most effective treatment available for advanced Parkinson’s disease, but without the need to implant a tube into the intestine. We have kicked off the collaboration with a manufacturer with extensive experience of producing pumps in line with our expectations and requirements.
In addition, we recently chose a partner for process development activities and for production of clinical trial material. Our efforts and investment in relation to chemistry, manufacturing, and controls (CMC) are critical for the ongoing projects. This is to ensure that we have clinical trial material for pivotal studies and ultimately a commercially viable production process in place.
Regarding our second product, Infudopa IntraV™, our goal is to commence a final minor clinical bioequivalence and tolerability study mid-2022. This product is intended for intravenous treatment to both enable and facilitate surgical procedures for Parkinson patients. During the year, we have initiated follow-up interactions with the health authorities in Europe and the US with the aim to file our applications for market authorization with both the EMA and FDA after completion of the final study.
Strong patents are critical to protect scientific advances. Therefore, an active patent strategy is a precondition for maximizing the commercial value of Dizlin’s scientific advances. In the beginning of the year, we were pleased to obtain a “Decision to Grant” by the European Patent Office regarding Infudopa SubC™.
Two years have passed since I joined the company as CEO, and I am proud of what the team has accomplished so far. We will now continue our important efforts to develop treatments that can improve the quality of life for Parkinson patients and their families. Thank you all for your interest in Dizlin Pharmaceuticals and I wish you all the best for the Holiday Season and the New Year.
CEO, Dizlin Pharmaceuticals AB