Johnson and Johnson’s (J&J) fully subcutaneous Tremfya (guselkumab) has shown a second round of success in ulcerative colitis (UC), with 27.6% of patients achieving clinical remission in a Phase III trial.
The randomised double-blind Phase III Astro trial (NCT05528510) study examined a subcutaneous injectable version of J&J’s blockbuster Tremfya for both induction and maintenance dosing in 418 adults with moderately to severely active UC, a form of inflammatory bowel disease (IBD) and an inadequate response to conventional therapies.
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Initial 12-week results found patients in the treatment arm seeing a clinical remission rate of 27.6% versus 6.5% for those in the placebo arm. At the same time, 65% of patients saw clinical response to the monoclonal antibody treatment, against 34% in the placebo arm. Additionally, 37.3% saw endoscopic improvement.
Esi Lamousé-Smith, gastroenterology disease area lead at J&J, said: “We aim to offer treatment options for patients with IBD that allow them to effectively manage their disease while also meeting the daily demands of life. These results further underscore the potential of Tremfya to transform the UC treatment paradigm.
“Pending approval, Tremfya would be the first IL-23 inhibitor with a fully subcutaneous induction and maintenance regimen, increasing options for both patients and healthcare providers.”
Tremfya is a fully human antibody created to neutralise inflammation by blocking IL-23, a cytokine that plays a part in autoimmune and inflammatory diseases. It is currently approved in the US for moderate to severe plaque psoriasis, psoriatic arthritis and UC. Currently, the company is seeking approval from the European Medicines Agency (EMA) for both UC and Crohn’s disease.
The announcement prompted a small jump in the company’s stock price, going from $157 per share to $159 per share at the time of publication. Research by GlobalData estimates that Tremfya brought in $3.8bn in 2024, with that figure expected to climb to $9.7bn by the end of 2030. Within the same time frame, the overall market for UC therapies is expected to rise from $7.1bn, up to $16bn.
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In terms of competition, there are currently only two other IL-23 inhibitors approved in the US besides Tremfya – Eli Lilly’s Omvoh (mirikizumab) and AbbVie’s Skyrizi (risankizumab). Both drugs brought in $132m and $11bn respectively, however, both currently rely on an initial intravenous infusion.
J&J’s competition does have the edge in certain IBD indications, however, with both Omvoh and Skyrizi having been granted approval for Crohn’s disease while Tremfya lacks the indication on its label. The Phase III GALAXI 2 & 3 studies however showed Tremfya to be efficacious in treating Crohn’s.
The Astro trial follows alongside the company’s Phase IIb/III Quasar study (NCT04033445), a dose-ranging induction study examining the therapy through intravenous infusion.
Laurent Peyrin-Biroulet, head of the IBD unit at Nancy University Hospital and study investigator, said: “The week 12 results from the Astro study build on data from the Quasar study demonstrating that both Tremfya subcutaneous and intravenous induction achieved clinically differentiated results in patients with moderately to severely active UC. The flexibility of a fully subcutaneous treatment regimen would be a welcome option for many patients, especially those with busy and active lifestyles.”
Elsewhere in the field of UC therapies, Palisade Bio has begun the multiple-ascending dose (MAD) cohorts of its ongoing Phase Ia/Ib trial of PALI-2108. Meanwhile, Cristcot has announced results from its Phase III trial examining its hydrocortisone suppository and applicator.
