Promore Pharma prepares phase II study
With its drug candidates, Promore Pharma targets two comprehensive patient groups whose access to pharmaceutical products is limited – wound care and scarring. The main project ensereptide is being developed to inhibit scarring, with the aim of initiating a phase IIa study in early 2022. The company’s second candidate, ropocamptide, for the stimulation of healing of chronic leg ulcers, is currently undergoing product development for an upcoming phase III study. BioStock talked to Promore Pharma’s CEO Jonas Ekblom to learn more.
Solna-based Promore Pharma, founded in 2002 and listed on First North since 2017, focuses on the development of peptide-based wound care drugs. This market is defined by an extensive lack of pharmaceutical products, even though sufferers of visible wounds or scars often experience both reduced quality of life and social stigma. The company’s goal is to position their product candidates as First-in-Category drugs, i.e. the first of its kind on the market.
Two candidates with a strong safety profile
Promore Pharma currently has two drug candidates in the late clinical development phase – ensereptide targeting scarring and ropocamptide for healing venous leg ulcers. Both candidates are based on endogenous peptides, i.e. substances that are already naturally present in our immune system and that contribute to healing. The fact that the peptides are endogenous, and thus broken down in the blood, means that the topically applied treatments never reach the body’s vital organs, which in turn means that the risk of serious side effects is minimal. The candidates´ strong safety profile has been confirmed in previous studies, which have also indicated promising efficacy.
Ensereptide about to enter phase II study
Entering the new year, the company now stands ready to take another significant step with its main project ensereptide. A phase IIa study will examine the candidate’s ability to inhibit scarring after surgery or trauma. Patient recruitment is expected to begin in early 2022. At the same time as Promore Pharma is preparing ensereptide for the upcoming study, the company is also working to further develop ropocamptide. At the end of 2020, a phase IIb study with the candidate was completed and the company is now focusing on optimising the administration for a future phase III study. In previous studies, ropocamptide has consisted of two components that needed to be mixed before use. The goal is now to create a more user-friendly single-component product.
The CEO comments
BioStock reached out to Jonas Ekblom, CEO of Promore Pharma, to find out more about the upcoming phase II study, the company’s strategy and what to expect next.
Jonas, could you start out by telling us about your professional background?
– I am an associate professor of pharmacology and for almost three decades I have worked with research and development of new drugs, medical devices and bioreagents.
– I have worked internationally for much of my career, and have had the privilege of working for companies in Sweden, the USA and Switzerland. I have been CEO of Promore Pharma and its predecessor since 2010.
Can you elaborate on in what situations Promore Pharma’s products are intended to be used?
– We develop products for two different medical applications. Ensereptide is developed as a treatment to prevent the appearance of unfavourable scarring on the skin associated with surgical procedures and after traumatic injuries.
– The second product candidate, ropocamptide, is developed as a treatment for venous leg ulcers, which are the most common type of hard-to-heal wounds on the legs and feet.
How do ensereptide and ropocamptide differ from today’s treatment options?
– Both of our products are intended as therapeutics. Today, there are actually no drugs registered either for the prevention of scarring or the treatment of venous leg ulcers. There are currently a plethora of products on the market that are not pharmaceuticals, but the efficacy of these products is generally very low.
Right now, Promore are focusing on the initiation of a phase II study with ensereptide. What can you tell us regarding the purpose of the study?
– This clinical trial (PHSU05) is a pilot study that aims to determine the safety, tolerability and effectiveness of ensereptide for the prevention of scarring after surgical incisions in the skin.
Can you guide our readers through the study design?
– We are conducting this study on circa 24 healthy volunteers. PHSU05 is a randomised, placebo-controlled double-blind study. Each subject will receive six small surgical incisions in the skin of the upper arms. After the incisions have been applied, these wounds will be randomised and then treated with a single dose of either ensereptide or placebo.
– The subjects will be followed for approximately three months after treatment. During the three-month evaluation, the degree of scarring will be measured in the healed wounds with various visual estimation scales and with histological analysis of small tissue samples.
You intend to start the patient recruitment at the clinic in Uppsala in the near future. What is the status of the necessary regulatory approvals?
– We have received approval from both the Ethical Authority and from the Swedish Medical Products Agency to begin this clinical trial. So we have all the approvals needed to start the PHSU05 trial.
When can the market expect to find out results from the study?
– We expect that the last patient can carry out their last clinic visit during the summer of 2022, but the results will not be able to be read until the winter of 2022/2023.
– The most time-consuming part of the study is the histological analysis that begins after the last patient’s last visit to the clinic. The histological analysis with subsequent statistical analysis is estimated to take about 3–4 months. Since the study is double-blind, the results are not decoded until all analyses are completed.
With two candidates in the late clinical development phase, the question of a market launch is raised. What is your strategy when you reach this stage?
– Although we have come a long way in the clinical development of our projects, significant clinical development work remains. To implement the final parts of development, and for market launch, we want to work with larger industry-leading companies that have financial resources, networks, and expertise.
What are the market prospects for your respective products?
– The market outlook is very good, as these are two gigantic markets, where there are currently no effective medicines. These markets are continuously growing in terms of the number of addressable patients. In addition, there are surprisingly few ongoing clinical trials of new drugs, which means that future competition from other products is considered to be low.
Promore Pharma is by all accounts entering an eventful year. What are you looking forward to the most in 2022?
– There are three things I’m looking forward to. In the short term, I look forward to being able to begin the PHSU05 trial of ensereptide for scarring on the skin. Later in the year, I hope that we will succeed in the technical development of a more user-friendly form of ropocamptide and, last but not least, the outcome of the PHSU05 study in about a year’s time will be a very important and exciting milestone for us.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.