When Promore Pharma looks back on 2022, it can look back on an eventful year with several important milestones achieved. 2023 does not promise to be any less hectic, in November the company announced that the results from the PHSU05 study with ensereptide for scarring on skin are expected to be available as early as April 2023. BioStock talked to CEO Jonas Ekblom about the past year and what awaits Promore Pharma.
The Solna-based biotech Promore Pharma is developing the drug candidates ensereptide (PXL01) and ropocamptide (LL-37) within advanced wound treatment. The purpose of the candidate ensereptide is to reduce scarring associated with surgery and trauma. In the ropocamptide project, Promore Pharma develops a new treatment for venous leg ulcers, the most common form of chronic leg ulcers in the Western world.
Focus is on phase II study
In Promore Pharma’s year-end report for 2022, focus is on the phase IIa study PHSU05 with ensereptide for scarring on skin. In February 2022, the first subject was included in the study and the study’s recruitment target was achieved as planned in March. The last clinic visit was carried out in June and in November the company announced that the results from the PHSU05 study are expected to be available in April 2023.
In February this year, the company achieved the milestone of Clean File in the PHSU05 study, which determines the timeline and structure of the study. According to the company, this means that the probability is now high that the outcome of the study can both be compiled and communicated during April 2023.
“The clinical part of the trial was completed in June 2022, and the work with the histopathological analysis is in a final phase,” CEO Jonas Ekblom states in the year-end report.
Patent for ropocamptide
There has also been progress for the company’s other candidate, ropocamptide, during 2022. Ropocamptide is developed to stimulate the healing of chronic wounds and is based on a human antimicrobial peptide that stimulates several cell types in the wound healing process. At present, two clinical studies have been conducted regarding the effect of ropocamptide in venous leg ulcers.
A phase IIa study in patients with venous leg ulcers, observed that ropocamptide at its most effective dose could result in a healing of the relative wound surface of over 75 per cent after one month of treatment. In the subsequent phase IIb trial, significant efficacy of the candidate was demonstrated in patients with wounds larger than 10 cm2. In addition to venous leg ulcers, Promore Pharma estimates that there is also significant potential to develop ropocamptide for treatment of diabetic foot ulcers.
In August 2022, it was announced that the European Patent Office, EPO, has granted an additional patent for ropocamptide to treat chronic wounds. The patent is valid until 2034 with the possibility of extension.
Looking at the financial statement, the result for 2022 after tax landed at – 26.6 million SEK, which was at the same level as the previous year. For the fourth quarter of 2022, profit after tax amounted to -6.8 million SEK, for the same period in 2021 it was -5.7 million SEK. At the end of 2022, the company’s cash and cash equivalents amounted to 17.8 million SEK.
BioStock spoke to Promore Pharma’s CEO Jonas Ekblom about the past year and what lies ahead.
Jonas, how would you describe 2022?
– We are pleased to note that during the year we have done exactly the things we planned to do, in accordance with the planned timeline, i.e. to carry out the clinic part of PHSU05 and to continue the development of a single-component product for ropocamptide against leg ulcers. However, as previously announced, we have a certain delay in the readout of the study results, which is due to the limited capacity of our external service providers in primarily histopathology.
You are expected to be able to communicate the results of the PHSU05 study in April, what is the next step for the development of ensereptide?
– In the coming weeks, the study results will be unblinded and analysed in detail, to complete a clinical study report. If the study shows that ensereptide is safe and tolerable, and that the results indicate that the experimental drug has an effect against scarring, we will plan for a follow-up phase II study.
You have positive phase II results for ropocamptide, which for many companies means that it is time to start a partnering process. ´ You also see potential to develop ropocamptide for diabetic foot ulcers. How do you see the way forward for ropocamptide?
– We continue to look for opportunities for strategic collaborations or to find other solutions to be able to finance the continued development of ropocamptide. The development of the single-component product is an important part of that process.
What milestones do you hope that Promore Pharma achieves in 2023?
– The outcome from PHSU05 is the single most important event of the year, it will set the agenda for our direction of travel for the rest of the year.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.