8 Dec, 2022

First patient dosed in Spago Nanomedical’s endometriosis Phase IIa clinical study

Spago Nanomedical AB (publ) today announced that the first patient in the Phase IIa clinical study with SpagoPix in endometriosis, SPAGOPIX-02, has been successfully dosed with the contrast agent SN132D and undergone magnetic resonance imaging (MRI).

This open label, proof-of-concept study is conducted at the Department of Obstetrics and Gynecology at Skåne University Hospital in Malmö, Sweden, and led by Associate Professor Dr. Ligita Jokubkiene.

It will evaluate the safety and MRI enhancing properties of the novel intravenous contrast agent SN132D in up to 18 patients with suspected endometriosis. Comparisons will be made to transvaginal ultrasound and conventional MRI in order to consider the diagnostic potential of SN132D in endometriosis.

“It is very encouraging that we already have the first patient dosed in the study. It clearly shows the interest among patients and health care professionals to participate in finding better options for diagnosis, enabling earlier detection and treatment of this debilitating disease effecting so many women and girls around the world,” said Mats Hansen, CEO at Spago Nanomedical.

SN132D in endometriosis
Endometriosis is a chronic disease of the female reproductive system in which cells similar to those in the endometrium, the layer of tissue that normally covers the inside of the uterus, grows outside the uterus, causing menstrual pain, pain at defecation and sexual intercourse, chronic pelvic pain and infertility. Like cancer, endometriosis is an angiogenesis-dependent disease that could be targeted by means of optimized functional nanoparticles.

It is estimated that at least 176 million women of reproductive age are affected worldwide and endometriosis accounts for societal healthcare costs of a similar order as diseases such as type 2 diabetes or rheumatoid arthritis.

Access to early diagnosis and effective treatment of endometriosis is important. Currently, the average time to diagnosis is 7 years and the clinical need for improved diagnostic technologies is high. Endometriosis represents a major market for any diagnostic agent that can improve, complement, or replace current standards. The estimated total addressable market for SN132D in endometriosis is €500M annually, which is significantly larger than that of breast cancer where the competition is higher.