TrialSite News recently reported on the success of XBiotech’s (NASDAQ: XBIT) Bermekimab in alleviating Hidradenitis Suppurativa symptoms. Recently, Dr. Alice Gottlieb, MD, PhD presented “Bermekimab Shows Efficacy for Treating Hidradenitis Suppurativa (HS) Including Marked Reduction in Pain” at the Walter E. Washington Convention Center in Washington, D.C.
As recently reported in Globe Newswire, Dr. Gottlieb showcased the substantial results 42 HS patients received based on 12 weekly injections of bermekimab therapy. The following benefits were presented:
- Excellent safety results
- Majority of patients achieved significant therapeutic benefit regardless of whether or not they had previously failed treatment with the only existing FDA-approved biological drug for HS treatment
- Significant reduction in pain
Pain is a major problem for many HS patients and has not been addressed by current medication available. Dr. Gottlieb showed that by week 12 of treatment, 63% of patients who have previously failed anti-TNF therapy achieved a positive HiSCR (the accepted measure of disease severity in HS); similarly, 61% of patients with no prior anti-TNF therapy achieved positive HiSCR. These results translated into a 46% (p<0.001) and 60% (p=0.005) reduction in the number of abscesses and inflammatory nodules, respectively, for the two groups. A breakthrough finding was that 67% and 72% of patients achieved a clinically meaningful reduction in pain by week 12.The existing FDA-approved biological therapy was only shown to reduce pain when used in combination with oral antibiotics. No antibiotics were used as part of the clinical study with bermekimab.
We assume next comes some for of Phase 3 trial then if all goes well an FDA and EMA filing for market distribution. XBiotech at time of writing is at $9.54 per share. We will monitor this carefully.