Systemic lupus erythematosus is an autoimmune disease that presents differently in each person. There are roughly 150 people with lupus per 100,000, and the vast majority of these patients – 90% – are female. Ethnicity seems to play a role as well. There are more people with SLE who are African American, Hispanic, or Asian than those of Caucasian descent. This pattern would suggest a genetic component, but SLE is not well understood, largely because of how unpredictably its symptoms present. Organs may be impacted, or the effects could be largely limited to the skin and joints. A butterfly-shaped rash on the face is a common complaint.
There is no cure for lupus and there is no certain cause, but there are several treatments and clinical trials underway for the securing the delivery of new ones. Pharm-Olam recently examined the competitive environment for SLE in our market analysis white paper, available here for download . Below we recap some of the current details found in the whitepaper regarding trials in progress.
Trials in Progress
As of August 2020, there are 49 open studies that focus on SLE in some capacity and there is an additional 27 in the planning phase. Of the open studies, 22 are in Phase-II and seven are in Phase-III. Planned studies are equally encouraging. There are 10 Phase-II studies planned and two Phase-III studies. Each new Phase is a landmark. Pharma Intelligence explained SLE drug approvals in a recent report: “The overall likelihood of approval of a Phase I SLE asset is 3.5%, and the average probability a drug advances from Phase III is 33.3%. Drugs for SLE, on average, take 9.6 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.”
Right now, there are several studies that deserve extra attention. Each one has a potentially high impact in treating and managing SLE.
- Phase II: BMS-986165, evobrutinib, iscalimab lenabasum
- Phase IIa: RSLV-132
- Phase III: anifrolumab, Benlysta
- Patent Expiration: INV103
Pharm-Olam as Lupus CRO Expert
Pharm-Olam, a contract research organization (CRO), has been providing clinical study services on various lupus conditions for years. We have completed 14 studies in Phases I-III on systemic lupus erythematosus (SLE). Our team is proactive and attentive to the competitive landscape surrounding specific conditions or areas of research. This understanding provides insights into both interventional and observational studies, allowing us to provide truly comprehensive CRO services in support of SLE or other Lupus related indications.
Please see our recently published white paper that surveys the SLE Lupus competitive landscape, available HERE.