First North-company Spago Nanomedical develops new diagnostic and treatment concepts based on polymeric nanoparticles with precise targeting of specific tissue. In Tumored The company is developing a new radionuclide therapy for cancer, where the drug candidate 177Lu-SN201 is currently being prepared for the first clinical studies in humans.
Within SpagoPixprogram, the company is developing a new gadolinium-free contrast agent for improved magnetic resonance imaging (MRI) of cancer and other diseases. The product candidate SN132D has undergone clinical trials in SPAGOPIX-01, a phase I study in breast cancer that has recently been completed. The first results from the study will be presented at 2022 San Antonio Breast Cancer Symposium (SABCS) on 6–10 December 2022.
Endometriosis – a widespread disease
Now Spago Nanomedical is turning its SpagoPix focus towards endometriosis, a chronic disease that according to WHO affects approximately 10 percent of women of childbearing age worldwide. The estrogen-dependent condition means that cells that normally grow inside the uterus have spread outside the organ, causing chronic inflammation that leads to very painful menstruation, bleeding, chronic abdominal pain and infertility.
For many of those affected, endometriosis, in addition to severe pain, also means a reduced quality of life in the form of fatigue, depression and anxiety. The condition is also associated with significant societal costs as those affected are often prevented from going to work or school due to their symptoms.
There are currently no curative treatments for endometriosis; current treatments aim to relieve symptoms through painkillers, various hormone treatments or surgery.
Spago Nanomedical starts phase IIa study in endometriosis
Several of the treatment methods alleviate the symptoms, but a major problem in healthcare is that it takes a long time to get a diagnosis – today you have to wait an average of about seven yearsThrough an early and more accurate diagnosis, affected women can receive treatment faster, and this is where Spago Nanomedical's product candidate can potentially make a difference.
In addition to faster treatment and improved quality of life for patients, Spago Nanomedical has also identified significant market potential for SpagoPix in the area. The company has estimated the total addressable market for SN132D in endometriosis at EUR 500 million annually.
BioStock had the opportunity to talk to the CEO Matt Hansen about the product candidate SN132D, the upcoming study and what it means for Spago Nanomedical.
Mats, before we get into the endometriosis study, what can you say about the SPAGOPIX-01 study?
– We are now concluding the SPAGOPIX-01 study after achieving our primary safety and initial efficacy endpoints. The results also indicate that they are consistent with the preclinical data we already had, further validating our technology platform.
– This week we will present interim data from the SPAGOPIX-01 study at a symposium in San Antonio, USA. We will publish the final results in the spring of 2023.
Will you continue the development of SpagoPix in the cancer field?
– With the successful SPAGOPIX-01 study, we have now laid the foundation for continued development. Being able to show that SN132D is safe and works as we expected is a very solid basis for further discussions with potential partners.
Now you are going to evaluate SN132D in endometriosis – why have you chosen this area?
– We have the opportunity to position SpagoPix in an indication where MRI does not work optimally today. It is a large area where competition is not as fierce as in the cancer area. Another aspect is that by showing that our technology potentially also works in endometriosis, we are not competing directly against potential partners' existing products in the cancer area.
In what ways can SpagoPix improve the situation for people with endometriosis?
– A major problem for affected women is that it takes too long to get a correct diagnosis and relevant treatment. By improving MRI diagnostics, we can also improve current methods, which include ultrasound and surgical procedures.
– Today's MRI technology works and is non-invasive, but there is a lack of an effective contrast agent. With SpagoPix, we can possibly also help guide curative surgery in a more precise way.
How is the study structured?
– The study will be conducted at Skåne University Hospital in Malmö under the leadership of Dr. Ligita Jokubkiene, associate professor and senior physician at the Department of Obstetrics and Gynecology. The study will include up to 18 patients and is very similar to the design of the SPAGOPIX-01 study. Patients suspected of having endometriosis will receive contrast media and we will compare with and without SpagoPix and we will also compare with ultrasound diagnostics.
Finally, can you say something about the timelines in the study?
– The study will start immediately and the first patient will hopefully be included soon. We then expect to be able to present results around mid-2023.
– This is a quick and efficient way for us to obtain an initial proof-of-concept within a very large indication where we see significant potential for SpagoPix.