SPI-47
An innovative combination therapy: Leveraging HSD-1 inhibition and the anti-inflammatory properties of glucocorticoids (steroids).
What is SPI-47?
An opportunity to revolutionize treatment of autoimmune diseases.
SPI-47 combines our proprietary HSD-1 inhibitor, clofutriben, with an effective steroid medicine, prednisolone. While prednisolone serves to relieve pain and inflammation, clofutriben is intended to lower active steroid levels within vital organs, and thereby mitigate the side effects of prednisolone, without substantially affecting its efficacy.
SPI-47 is being developed first for polymyalgia rheumatica (PMR). Patients with PMR often develop giant cell arteritis (GCA), and SPI-47 may also relieve the effects of this devastating disease, as well as many other autoimmune and inflammatory disorders.
The battle between efficacy and toxicity has plagued prescription steroids for more than 70 years. With the success of SPI-47, we may be able to finally resolve the choice patients currently must make between the debilitating symptoms of their disease and the severe side effects of their medication. Our novel therapy has the potential to change of the lives of millions suffering from debilitating autoimmune and inflammatory diseases.
Potential Benefits
High Efficacy
A recent study demonstrated the ability of an HSD-1 inhibitor to mitigate prednisolone’s acute adverse effects on key biomarkers without impacting a measure of immune response.¹
Strong Safety
In five clinical trials, SPI-62 showed a favorable safety and tolerability profile with few adverse effects.
Compatibility with Current Practice
Oral dosing consistent with dosing regimens of today’s steroid medicines.
Future Plans
A Phase 2 clinical trial of SPI-47 for patients with PMR initiated in 2022.
¹ Othonos, Nantia, et al. TICSI, 2020. https://www.endocrine-abstracts.org/ea/0070/ea0070oc3.6