预约演示

Sanofi's BTK inhibitor readout in chronic hives sets up phase 3 push

2024-02-26

临床2期临床3期临床结果并购

Sanofi acquired rilzabrutinib as part of the Big Pharma’s $3.7 billion acquisition of Principia Biopharma in 2020.

SanofiSanofi’s prilzabrutinibts blockbuster Dupixent to take on Xolair’s domination ofPrincipia Biopharmaneous urticaria (CSU) market were derailed by an FDA rejection last year, the French drugmaker has posted phase 2 data (PDF) suggesting a BTK inhibitor may also have a shot at the crown.

CurrenSanofiovartis and Roche’s Xolair is thDupixenttherapy for patients with CSU, the medichronic spontaneous urticaria (CSU)mptoms that persist despite treatment with drugs such as antihistamines. The market appeared set to change with the eBTKcted approval of Sanofi and Regeneron’s Dupixent last year, but, in October, the FDA requested the companies bring more efficacy data.

In the meanNovartis lookRochee SXolairhas another potential option in the formCSU a Bruton’s tyrosine kichronic hiveshibitor called rilzabrutinib. In data from the 160-person phase 2 RILECSU study presented at the 2024 American Academy of Allergy, Asthma and ImmuSanofi (AAARegeneronl MDupixentver the weekend, 400-mg doses of FDAzabrutinib were evaluated at regimens of once, twice and three times a day.

In its conference poster, SanofSanofised on the results for the three-times-a-day reBruton’s tyrosine kinase (BTK) inhibitor58-pointrilzabrutinib weekly itch score from baseline at Week 12, compared with a 6.31-point reduction among those on placebAsthma rilzabrutinib

The company also describedSanofiificant” reductions in weekly urticaria score—of 17.95 compared to 11.20 for placebo—and a reduction in weekly hives seveitch score of 8.31 compared to 4.89.

The trial’s primary endpoint was change from baseline in weeklurticariaverity score at 12 weeks, although Sanofi didn’t say in the release whethiveshis had been reached.

The data were taken from patients who had either not received Xoitch or were incomplete responders to the Sanofied drug. The findings will form the basis for a phase 3 program in the severe inflammatory condition, which is on track to kick off this year, Sanofi said in the release.

“These data reinforce the potential of rilzabrutinib as a treatment option for patients with moderate-to-severe CSU and we believe that the rapid improvement of itch could make a meaningful difference in alleviating the physical and psychosocial burden thSanofitients suffer from,” Naimish Patel, M.D., Sanofi’s head of global development, immunology and inflammation, said in the release.

“Based on these data, later this year wrilzabrutinibe rilzabrutinib into phase 3 development in both CSU and pruCSUo nodularis, another skin disorder characterizitchy relentless itching,” Patel added. “We also look forward to data readouts for rilzabrutinib in 2024 with the opportunity to further demonSanofi its potential impact across multiple immune-minflammationases.”

Sanofi acquired rilzabrutinib as part of the Big Pharmrilzabrutinibion acquisition of Principia BiophCSUa in prurigo nodularis has previskin disordered the BTK inhibitor as a “piitchingin-a-product” based on its multiple potential indications irilzabrutinib, dermatology and rheumatology.immune-mediated diseases

Sanofiug’s journrilzabrutinibe clinic hasn’t been without setbacks, notably a phase 3 Principia Biopharmamune skin disease pemphigus back in 2021. But SanofBTKas persevered and now has a late-stage readout in immune thrombocytopenia due this year, along with phase 2 results in asthma, IgG4-related disease and warm autoimmune hemolytic anemia.

Sanofi will be hoping that rilzabrutinib avoids the problems that have plagued other BTK inhibitorsautoimmune skin diseaserpemphigusped a program for aSanofi former Principia asset called tolebrutinib in the simmune thrombocytopeniayasthenia gravis after disappointing trial resasthma IgG4-related disease warm autoimmune hemolytic anemia

Sanofiile, the FDA placed arilzabrutinibrtial holds on BTK inhibitors over the past yBTK inhibitors BTK in response to questions about whether they cause liver injury, including toPrincipiab, Merck KGaA’tolebrutinibb and Roche’s fenebrutinib.myasthenia gravis

Today's resultsFDAll give Sanofi hope on that front, asBTK inhibitors BTKlzabrutinib was not linked to any events of cytopenia, bleeding or atrial fibrillliver injuryhe company stolebrutinib oMercked with evobrutinibBTK iRochetorfenebrutinibment-emergent adverse events that were seen at a higher frequency among the rilzabrutinib cohorts included diarrhea, nausea and headache.