Acelyrin Inc. said a vendor used by Fortrea Inc., a CRO the company used for its phase IIb/III study testing interleukin-17A inhibitor izokibep in psoriatic arthritis, incorrectly programmed the study’s protocol and created a dose sequencing error, resulting in some patients in two of the four dosing arms to randomly receive placebo and active treatment instead of the intended alternating pattern. The discovery has prompted a review of other studies involving the CRO, including a study that failed to reach statistical significance in September.
Acelyrin Inc.’s shares tumbled after its interleukin-17A inhibitor, izokibep, failed to reachstatistical significance in part B of a phase IIb/III trial inmoderate to severe hidradenitis suppurativa (HS), but the company remains undeterred with its plans to advance the drug for the inflammatory skin condition.
Less than a week after Eli Lilly and Co.’s $2.4 billion, IL-17-based buyout of Dice Therapeutics Inc., Moonlake Immunotherapeutics Inc. offered more news in the space by way of data from the global phase II trial called Mira evaluating the efficacy and safety of the Nanobody sonelokimab in moderate to severe hidradenitis suppurativa (HS).
A heart-protective cardiac myosin inhibitor and two biologics – one for a type of non-Hodgkin lymphoma and another for an inflammatory skin condition – were among the therapies recommended for approval by the EMA’s Committee for Medicinal Products for Human Use this week.
Inmagene Biopharmaceuticals Co. Ltd. has obtained IND approval from the FDA for IMG-008, the company's novel long-acting antagonistic humanized monoclonal antibody that specifically targets human IL-36 receptor (IL-36R) to treat auto-inflammatory diseases.
Novartis AG rolled out positive phase III data Sept. 13 with Cosentyx (secukinumab), its interleukin-17A (IL-17A) inhibitor for hidradenitis suppurativa, offering more evidence for the approach taken up by a handful of biopharma firms.
Moonlake Therapeutics AG is making headway on its mission to establish a broad dermatology and rheumatology franchise around its sole product, sonelokimab, announcing it is poised to start a phase II study in hidradenitis suppurativa.
Inflarx NV has submitted a special protocol assessment (SPA) to the FDA for the phase III trial with vilobelimab against the skin disorder hidradenitis suppurativa (HS), pleasing investors with clarity regarding the path forward for the drug, which is in the works for antineutrophil cytoplasmic antibody-associated vasculitis (AAV) as well – and faces competition on both fronts.
With avacopan’s PDUFA date in anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis) set for next summer, Chemocentryx Inc. rolled out long-awaited, COVID-19-delayed top-line findings from the company’s phase II, 390-patient Aurora study testing the compound for hidradenitis suppurativa (HS).
LONDON – Janssen Biotech Inc. is buying Xbiotech Inc.’s interleukin-1a (IL-1a) inhibitor bermekimab for $750 million up front and will pay a further $600 million in potential milestones as the product advances in development for the treatment of atopic dermatitis and the chronic immune-mediated skin disease, hidradenitis suppurativa (HS).
