Acelyrin, Inc, a late-stage clinical biopharma company dedicated to delivering transformative medicines in immunology, has announced remarkable data from their Phase 2b/3 trial in patients with moderate-to-severe Hidradenitis Suppurativa (HS). The trial revealed that izokibep treatment resulted in high orders (HiSCR75 and above) of HiSCR response at 12 weeks, including HiSCR100 responses in 33% of participants.
Sufferers of HS deal with the debilitating effects of abscesses, nodules, fistulae, pain, scarring and malodor, which can drastically reduce the quality of life. Acelyrin Inc. will present this groundbreaking data at the AAD Annual Meeting on March 18, 2023.
At ACELYRIN, we are committed to finding innovative therapies to improve the quality of life of people living with Hidradenitis suppurativa. We believe that izokibep, with its high potency against IL-17A and small molecular size which allows for deep tissue penetration, has the potential to provide powerful clinical responses.
Today, we are thrilled to report that izokibep has been delivering HiSCR responses that have been lasting up to 12 weeks and have already seen the drug’s potential in Psoriatic Arthritis. We are dedicated to continuing to explore the potential of izokibep to impact the lives of those living with HS.
At a trial conducted in multiple locations across the US, participants with Hurley Stage II and III disease were given a weekly dose of 160 mg izokibep subcutaneously. By the 12th week, the results were impressive: 71% achieved HiSCR50, 57% achieved HiSCR75, 38% achieved HiSCR90, and 33% achieved HiSCR100 – a remarkable achievement that had not been seen before with any other product.
Previous studies of other agents have documented a low-to-none placebo response rate for HiSCR75 and higher. For instance, in a phase 3 study of adalimumab, the placebo response rate for HiSCR90 was a mere 7%, while in a phase 2 study of bimekizumab, the placebo response rate for HiSCR90 was a remarkable 0%. These results demonstrate the efficacy of these agents in treating Crohn’s disease.
Izokibep was generally well-tolerated, with localized mild-to-moderate injection site reactions being the most common side effect. However, three serious adverse events were observed in two subjects: one with pre-existing symptoms of inflammatory bowel disease, and another with pre-existing symptoms of diverticulosis who experienced peri-colonic abscess/sepsis. Thankfully, there were no candida events reported through week 12.
The Phase 2b/3 trial of ACELYRIN is currently ongoing, with Part B being a double-blind, placebo-controlled study. After the promising results of Part A, ACELYRIN is eagerly looking forward to kick-starting the second Phase 3 trial in HS. This is a major milestone in their journey to revolutionize the healthcare industry!
Izokibep is a revolutionary protein therapeutic, with the potential to revolutionize treatment of immunological conditions. It’s remarkable potency and small molecular size (about one-tenth the size of a monoclonal antibody) allows for impressive tissue penetration.
To date, Izokibep has been administered across multiple clinical trials for indications such as hidradenitis suppurativa (HS), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA) and uveitis, to over 400 participants, at doses up to 160 mg, and in some cases for up to three years.
About Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS) is a debilitating chronic skin condition that can cause a devastating impact on quality of life. Affecting an estimated 317,000 patients in the United States, it can lead to scarring, abscesses, malodor, and pain in areas with high concentrations of sweat glands.
50-60% of HS patients experience moderate to severe symptoms, and they often miss more days of work and have a higher degree of disability than the average population. HS can be a difficult condition to manage, but with proper care, individuals can lead a fulfilling life despite it.
Acelyrin, Inc., a biopharmaceutical company based out of the greater Los Angeles area with an additional presence in the San Francisco Bay area, is committed to unlocking life-changing new treatment options for patients. By strategically locating and acquiring promising drug candidates, Acelyrin is working to expedite the development and commercialization process.