Teva announced it was partnering with Sanofi to further develop duvakitug for treatment of IBD in October last year. The drug was developed by the Israeli big pharma to target TL1A (TNF superfamily member 15), believed to amplify inflammation and drive fibrosis in IBD.
As part of last year’s agreement, Teva received US$500 million from Sanofi as an upfront payment and is eligible for up to $1 billion in milestone payments if duvakitug reaches the market. Both companies are sharing development costs and potential profits, and Sanofi will lead phase 3 development of duvakitug.
The two companies announced this week that the RELIEVE UCCD phase 2b study, which included almost 300 people, had met its primary endpoints in patients with ulcerative colitis and Crohn’s disease, the two most common forms of IBD.
The study tested a low and a high dose of duvakitug versus placebo in both patient groups over 14 weeks. The researchers found that after adjusting for placebo, 15.7% and 27.4% of low and high dose patients with ulcerative colitis achieved clinical remission. Similarly, 13.0% and 34.8% of low- and high-dose treated Crohn’s disease patients achieved remission after adjusting for placebo.
The drug appeared to be well-tolerated across both disease groups with no serious safety issues identified and similar levels of side effects seen in the placebo versus the treatment groups.
“These unprecedented results show that duvakitug could represent the next frontier in treating ulcerative colitis and Crohn’s disease. If the magnitude of effect persists in the phase 3 program, we believe we will have a differentiated medicine for IBD patients who are in urgent need of new options,” said Houman Ashrafian, Executive Vice President, Head of R&D at Sanofi, in a press statement.
New pathways for treating IBD
There are already a number of treatment options available for people with Crohn’s and ulcerative colitis, both autoimmune conditions impacting different parts of the gut and bowels. In addition to other therapies, 11 biologic drugs have been approved around the world to treat one or both of these chronic conditions.
These include anti-TNF alpha therapies such as infliximab or adalimumab; anti-integrin or anti-interleukin agents like vedolizumab and ustekinumab; and JAK inhibitors such as tofacitinib; among others.
However, although these therapies are very helpful for some people, they don’t work for everyone and side effects can be tough, meaning there is still room for new treatments for these conditions.
Initially trialed unsuccessfully in asthma, duvakitug (also known as TEV-48574) showed more promise for patients with IBD. TL1A is a new target for IBD but has shown good results in the trials of duvakitug carried out so far. If it can maintain its high efficacy and good side effect profile at phase 3 then duvakitug has the potential to be very successful if approved.
