The reporting season is in full swing, and biopharmaceutical company Promore Pharma has now joined the list of companies that have reported on the second quarter. CEO Jonas Ekblom emphasises that the first months of the year have been characterised by intensive work that has resulted in the company advancing its two candidates according to plan. BioStock took the opportunity to ask Ekblom three quick questions about the report.
Promore Pharma is working determinedly to bring its two candidates within wound healing – ensereptide and ropocamptide – to patients. The company’s lead candidate, ensereptide, is to inhibit scarring and is now undergoing a phase II clinical trial. Ropocamptide is being developed as a treatment for venous leg ulcers, the most common form of chronic leg ulcers. Reading Promore Pharma’s latest report it becomes clear that the company’s work, despite a troubled global situation, is progressing according to plan towards the goal of providing patients who currently lack prescription drugs with improved treatment options.
The clinical part of phase II study is completed
The quarter’s most important progress came within the ensereptide project where Promore Pharma is conducting a phase II study called PHSUO5. After the study was fully recruited in March, June saw the good news that the last patient had completed the last clinic visit. This means that the company achieved its goal of treating and following up 24 patients during the first half of 2022. The study is now progressing according to plan with two remaining parts – a histopathological analysis of collected biopsies and an analysis and quality assurance of the data. Promore Pharma expects to be able to present final data from the study during the first quarter of 2023.
With regards to ropocamptide, the second quarter saw Promore Pharma continue the work to develop a more user-friendly form of administration. In his CEO statement, Jonas Ekblom emphasises that the risks in the project have been reduced by creating a solid manufacturing process and that Promore Pharma is now collaborating with external service providers to secure the manufacturing process. The plan for ropocamptide also includes a phase III study in the EU, but Promore Pharma has not yet made a decision on funding or when such a study could be initiated.
Read more about the patent that ropocamptide was awarded in August here.
New chairman of the board
It was not just on the clinical front that things happened during the quarter. At the Annual General Meeting in May, Marianne Dicander Alexandersson, board member of Promore Pharma since 2017, was elected as the new Chairman of the Board. Dicander Alexandersson, with a master’s degree in engineering from Chalmers University of Technology on her CV, has many years of industry experience and has, among other positions, been CEO of Kronans Droghandel and Sixth AP fund.
Solid financial position
A closer look at the company’s financial accounts shows that operating loss for the period April – June landed at 6.1 million SEK, compared with 7.8 million SEK for the same period last year. Cash flow from operating activities amounted to 6.8 million SEK. CEO Jonas Ekblom states in the report that the company’s cash position is stable and that, according to his assessment, it has the resources required to run the company according to plan for at least a year to come.
BioStock took the opportunity to ask Jonas Ekblom three quick questions based on the report.
Jonas, can you elaborate on what is happening now in the ensereptide project?
– In June, we reached the goal of carrying out the last patient visit (Last-Patient-Last-Visit; LPLV). We are now working on analysing the tissue samples collected during the clinical trial. This is the most technically complicated and comprehensive part of this clinical study. During this analysis, that will take several months, all data is still double-blinded.
– We expect to be able to lock the database shortly after the turn of the year, and then unblind and statistically compare the outcome between wounds treated with the active substance vis-à-vis placebo.
There are plans for a phase III study with ropocamptide, but no decisions regarding funding or start of such a study have been made. What pieces need to fall into place in order for you to make such decisions?
– The single most important piece of the puzzle is to ensure that we can develop a robust, economical and scalable manufacturing process for a single component product. This development will take place during the rest of the current year. When this is completed, hopefully with a positive result, we will have to decide what the conditions are like in terms of financing such a study.
In the report, you mention the uncertain situation in the world today. Despite this, Promore has succeeded in following your plan, but how do you view the risk that Promore Pharma’s work will be affected by the conflict in Ukraine?
– We do not see any specific risks at this time. We are pleased to have a cash position that gives us a financial runway of about a year. At present, the conditions for raising capital are very strained.