Biotechnology company Pila Pharma develops XEN-D0501 for the treatment of type 2 diabetes, targeting the protein TRPV1, which has been shown to play a role in the body's insulin secretion - making it a natural parameter in the disease.
According to the company's hypothesis, excess adipose tissue in the body stimulates TRPV1 receptors more than usual, which starts an inflammatory process that inhibits insulin production and insulin sensitivity. This can lead to a vicious cycle where the body tries to compensate, which in turn triggers the abnormal inflammatory response. The idea with XEN-D0501 is to inhibit the TRPV1 receptor to break this vicious cycle.
Read more about the company's clinical concept here.
Advancing towards phase IIb
Since last year's listing on Nasdaq First North Growth Market The company has focused on building a strong team that will take the candidate to phase IIb studies and then further development. Among other things, the Franco-Italian contract research company was contracted ERBC, whose task is to conduct a three-month preclinical toxicology study, which is a prerequisite for the company to be able to proceed with the longer 3-month clinical studies.
The purpose of the toxicological study is to ensure that the candidate has a good safety profile – a milestone that, if successful, significantly reduces the risk in the project. Pila Pharma sees limited risk with this study, as the German company Bayer, which developed the development candidate, has already previously conducted a 1-month toxicological study with good results. The new study simply aims to confirm the good safety data that has already been obtained regarding XEN-D0501.
Pila Pharma announced at the end of last week that ERBC has now begun the 3-month study and if all goes as expected, the company is expected to be able to initiate phase IIb studies sometime next year.
Comments from the CEO
After this, it was also announced that the company's CEO Dorte X Gram continues to increase her holding in the company. On Thursday, June 30, she purchased 12 shares at an average price of SEK 700 through the company Gram Equity Invest. After the transaction, Dorte controls a total of 5 shares, which corresponds to just over 063 percent. BioStock took the opportunity to contact her to find out more about the latest milestone.
You have already conducted a toxicology study with XEN-D0501, why are you now doing another one?
– Since we want to conduct a clinical study that lasts 3 months, it is a prerequisite for being able to obtain permission that you can show that the substance is safe during the same dosing period in two different animal models – “rodent and non-rodent”. The authorities want some form of evidence that XEN-D0501 is well tolerated in animals before allowing humans to be treated, so it is a regulatory requirement that we must meet if we want to continue the development of XEN-D0501.
– After phase IIb – when we are in phase III and before registration – there are also other toxicological studies we must conduct with good results, such as reprotox and carcinogenicity. However, this is not a requirement for phase IIb and, as I said, these are studies that come later.
There have been some questions about the financial situation, given the generally sour stock market climate. How do you view that issue?
– When we were listed, we issued warrants of series TO1 with an exercise price of SEK 10, which will not be exercised as the share price is below that level. We have sufficient capital for the coming period and in addition to the work to start the toxicology study, work is underway to raise the capital that will be needed to carry out the clinical program that lies ahead of us. We will provide more information about this as soon as possible after our second quarter report is released.
You also continue to increase your holding in the company. Why is that?
– When Pila Pharma's share is at the price it is at right now, I simply don't see any better investment. It is true that the situation on the stock market is generally uncertain, but on the other hand we have a very good drug candidate for the treatment of type 2 diabetes that has enormous market potential. We also prove time and time again that development is going according to the plan that we have communicated to the stock market. But it is clear that you have to be long-term when investing in a share like Pila, as the theoretical increase in value is at least a couple of years away.