Last Wednesday, Solna-based Promore Pharma released its year-end report, and, on the same day, the company was able to communicate news regarding its phase II study with the candidate ensereptide. In accordance with the company’s timetable, the first patient has now been recruited for the study on scarring. BioStock contacted CEO Jonas Ekblom to find out more.
Promore Pharma is active within the development of treatments for wound care, an area where pharmaceutical products are lacking. To meet patients’ needs, the company develops two drug candidates, both of which are in the late development phase. Ensereptide is primarily developed to prevent various forms of skin scarring, while ropocamptide is aimed at the healing of venous leg ulcers.
Patient recruitment initiated in phase II study with ensereptide
One of Promore Pharma’s main goals for 2022 is to carry out a phase II study, called PHSU05, with ensereptide. Last week, the company reached a milestone on the way to this goal by recruiting the first patient for the study. This means that the company follows the timetable previously communicated, meaning that it expects to be able to present a final study report during the winter of 2022/23.
The purpose of the randomised, double-blinded pilot study, conducted at Uppsala University Hospital, is to evaluate the candidate for local tolerance, the application process, and preliminary effect regarding scar prevention after experimentally induced wounds in healthy volunteers.
Professor Margaret Mahlapuu, CSO at Promore Pharma, expressed her delight at the patient recruitment in a press release:
»I am very happy that the first patient was recruited in the PHSU05 study. The need to develop new strategies and treatments that prevent scarring is very important.«
Events during the autumn
Last Wednesday, Promore Pharma also released its year-end report for 2021. Among the events of the past autumn we can note the approval from the relevant authorities to start the phase II study with ensereptide, an approval that has now resulted in the recruitment of the first patient.
In the case of the company’s other candidate, ropocamptide, Promore Pharma was granted a patent in December regarding the treatment of chronic wounds, which protects innovation in the US market.
Ropocamptide is primarily developed for the treatment of venous leg ulcers and, in October, a peer-reviewed scientific article in this indication was published in the journal Wound Repair and Regeneration. The article is based on the results of the phase IIb study that the company completed in 2020 and represents a validation of the quality of the study. Promore Pharma is currently working to develop an improved, more user-friendly form of administration of ropocamptide for future clinical studies. Read more.
BioStock contacted Promore Pharma’s CEO Jonas Ekblom for a comment regarding the report and the fact that patient recruitment has now begun.
Jonas, if we start with the year-end report, how would you describe Promore Pharma’s financial situation?
– The financial situation is stable. We can conclude that we have had a slightly lower expenditure in 2021 than what we had estimated. We are therefore well within the framework of the budget for our operational plan.
You achieved some significant milestones in the fourth quarter, but if we look at the full year, are you satisfied with what you have achieved?
– During the fourth quarter, we received approval from the relevant authorities for our PHSU05 clinical trial regarding ensereptide and prevention of skin scarring, and we also received an important patent approval in the US regarding ropocamptide and the treatment of chronic wounds.
– We are very pleased with the year as we achieved all the essential operational goals. The most important activity in 2021 has undoubtedly been the extensive work to prepare for the PHSU05 clinical trial.
You have now announced that the first patient has been recruited in the study with ensereptide. Can you tell us what the timeline for the study looks like?
– In the PHSU05 study, we will have a recruitment period over the next two months, when subjects will be included. We expect to be able to communicate that we have recruited all subjects for the study during the beginning of the second quarter 2022. We then expect that the last patient will have his/her last visit to the clinic in late summer.
– Then, in the autumn, we will conduct a histopathological evaluation of biopsies from the subjects. This process is carried out as an intricate collaboration between four different service providers in Sweden and the USA. We expect to be able to unblind study data and report results from the trial during the winter of 2022/2023.
In the ropocomptide project, you are developing a new form of administration – when do you expect this to be completed?
– We expect to be able to establish an appropriate manufacturing process in the spring of 2022, and to be able to have information regarding product stability in the autumn of 2022.
Finally, what is Promore Pharma’s focus for the first half of 2022?
– The first six months will be very important to us. In the PHSU05 study, we want to complete the recruitment phase of the trial, i.e., reach the last-patient-in milestone. We also hope to be able to provisionally establish a manufacturing process for ropocamptide as a single component product.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.