Spago Nanomedical has announced positive top line data from a clinical phase IIa study in patients with endometriosis. SPAGOPIX-02 study is evaluating the MRI-enhancing effect of the contrast agent pegfosimer manganese. The data confirms that the primary endpoint was met, without compromising safety. BioStock reached out to Spago’s Chief Executive Officer Mats Hansen to learn more.

First North-listed Spago Nanomedical develops new diagnostic and treatment concepts based on polymeric nanoparticles with precise targeting of specific tissue. Within the company’s Tumorad programme, Spago is developing a new radionuclide therapy for cancer, where the drug candidate ¹⁷⁷Lu-SN201 is currently being evaluated in a phase I/IIa trial. The first patient was dosed in this trial last week. Read more here.

Within the SpagoPix programme, focused on imaging diagnostics, Spago is developing a new gadolinium-free contrast agent for improved magnetic resonance imaging (MRI). The contrast agent, previously known only as SN132D, has been granted the official generic name pegfosimer manganese by the World Health Organisation (WHO).

Top line phase II SPAGOPIX data

Spago is currently completing a phase IIa study with pegfosimer manganese in suspected endometriosis patients. Read more about endometriosis here.

The primary objective for the SPAGOPIX-02 open-label is to evaluate the MRI-enhancing properties of pegfosimer manganese in these patients. Secondary objectives included evaluations of the diagnostic value of pegfosimer manganese for the detection of endometriosis lesions, specifically deep pelvic endometriosis lesions, as well as safety.

According to Spago, top line data from the study indicates that the primary objective has been reached. An analysis of the MR-images from the study shows that contrast enhancement with pegfosimer manganese was observed in the majority of lesions confirmed by unenhanced ultrasound. Moreover, the overall safety matched the preliminary conclusion previously announced by the study Data Monitoring Committee (DMC).

Dr Ligita Jokubkiene, MD and Senior Consultant at Skåne University Hospital and Principal Investigator of the trial was very pleased with the data:

“We have achieved the purpose of the study and show the potential of pegfosimer manganese in medical imaging of endometriosis lesions. The results and conclusions from this first clinical trial are encouraging. This provides confidence and generates hypotheses to be evaluated in the next steps.”

Q&A with the CEO

BioStock reached out to Spago’s CEO Mats Hansen to learn more about the study results and what comes next for SPAGOPIX.

Mats, how does pegfosimer manganese compare with other contrast agents?

– The main advantage as we see it is the selectivity for cancerous and inflammatory lesions that could increase precision of MRI and provide more detailed information to the treating physician. In endometriosis current low molecular weight contrast agents are not really helpful, contributing to a major delay in adequate diagnosis and treatment to these patients. The fact that pegfosimer manganese is not based on gadolinium (Gd) eliminates the risk for Gd-retention toxicity, and provides a positive sustainability aspect.

More specifically in relation to endometriosis, why is there a need for new contrast agents?

– Endometriosis is a severely underserved chronic condition that has a tremendous effect on the quality of life for many women and girls, approximately up to 10 percent of women of reproductive age suffering from endometriosis worldwide. Pain and infertility are the clinical hallmarks of the disease, affecting not only those affected with endometriosis, but also partners, families, and the wider society. The average delay of diagnosis has been stated as 7 years, highlighting the difficulty to correctly visualise the disease by current means. Ultrasound is the gold standard for imaging but it is highly operator-dependent and does not provide good enough sensitivity. MRI provides very good resolution but better precision in endometriosis lesion identification is needed, especially for so called deep lesions which are the most critical ones to identify from a therapeutic point.

What is the potential of pegfosimer manganese in other indications?

– Before the phase IIa study in suspected endometriosis patients was initiated, the contrast agent was successfully evaluated in a phase I clinical study, SPAGOPIX-01, in patients with confirmed breast cancer. Results from that study showed that pegfosimer manganese is well tolerated and provides clear contrast in MRI images of solid tumours in the breast, as well as in the pancreas and liver.

What is the overall significance of this phase IIa analysis?

– The top-line data reported show that we achieved the primary aim of the study, to demonstrate potential utility of pegfosimer manganese in a large indication outside solid tumours. This is of great importance for the continued development of the SpagoPix programme in endometriosis, an indication with an estimated total addressable market of €500M annually which is even larger than that of breast cancer where the competition with current standard MRI and other modalities is higher. The results also provide valuable hypotheses for the next steps of development and builds confidence for partnership discussions.

Finally, what comes next for the SpagoPix programme?

– With the promising phase IIa data from the SPAGOPIX-02 study we have demonstrated the potential of pegfosimer manganese in medical imaging of endometriosis lesions and we will now continue preparing the full analysis of the results along with compilation of the clinical study report. We expect to have the final results published in one or several appropriate scientific journals and at scientific conferences later next year. The conclusions of all available clinical results with pegfosimer manganese will provide important basis for careful assessment of development pathways and commercial alternatives.

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