Immunic Doubles Down On Lead Asset With New Data In Ulcerative Colitis
Executive Summary
The company is emphasizing development of vidofludimus calcium in multiple indications and deprioritizing izumerogant, an asset the company was developing in psoriasis and prostate cancer.
Immunic Inc announced positive Phase II data for vidofludimus calcium in ulcerative colitis, contributing to management’s decision to invest more in that asset and pivot away from a different drug candidate, izumerogant (IMU-935), an oral drug n development for psoriasis.
Vidofludimus calcium is Immunic’s lead drug candidate, but the development focus has been on multiple sclerosis (MS), where the company is studying it in a Phase III study in relapsing-remitting MS, with interim data expected in 2024. Vidofludimus calcium inhibits dihydroorotate dehydrogenase (DHODH), which modulates the activity of T- and B-cells, according to the company.
“Although we haven’t decided on any particular path forward in UC, we do want to allocate internal resources to exploring options for this late-stage asset,” CEO Daniel Vitt said in a 5 April call outlining the results of the positive CALDOSE-1 trial. The data results were “somewhat unexpected,” he acknowledged.
“Meanwhile, for IMU-935, the totality of available data suggests a more complex picture,” he added.
The Phase Ib trial of IMU-935 that reported out last year in psoriasis showed a high placebo response rate and a lack of separation between the treatment and placebo arms. (Also see "Immunic Psoriasis Analysis Adds Dose Of Uncertainty To Program" - Scrip, 21 Oct, 2022.) Izumerogant is an orally available inverse agonist of RORγt that inhibits the IL-17 pathway, a well-validated target for psoriasis but currently marketed IL-17 inhibitors are biologics that are administered with an injection.
In the maintenance phase of the CALDOSE-1 trial, results showed a 30mg dose of vidofludimus calcium was statistically superior to placebo in achieving clinical remission in patients at week 50, with a 33.7% absolute improvement over placebo. A dose-linear increase in endoscopic healing was also observed, with the 30 mg dose associated with a statistically significant 37.8% absolute improvement over placebo.
The earlier Phase IIa ENTRANCE study also showed that treatment with vidofludimus had a high response rate in replacing steroids among steroid-dependent UC patients.
Additionally, the safety data in CALDOSE-1 were encouraging and revealed no unexpected adverse events. Treatment-emergent adverse events in both the 10mg and 30mg dose groups of vidofludimus calcium were comparable with placebo. There were no increased rates of liver events, liver enzyme elevations, or renal events. The encouraging safety profile could make vidofludimus calcium and attractive candidate for combination treatment for ulcerative colitis, Vitt indicated.
That could make the drug attractive to a large pharma company, many of which are investing substantially in the disease area. The space is competitive and several big pharma companies hope to bring new biologic or oral ulcerative colitis medicines to market as well. (Also see "IBD Market Snapshot: Changes Ahead, But Current Biologics Are Formidable Competitors" - Scrip, 11 Nov, 2022.)
“Some biologics, for example, really lend itself to combination with vidofludimus calcium,” Vitt said, pointing to drugs like Johnson & Johnson’s Stelara (ustekinumab) and Takeda Pharmaceutical Co. Ltd.’s Entyvio (vedolizumab) as potential examples.
“In light of today’s data, we see a big opportunity and high value opportunity in exploring vidofludimus calcium and potential improved derivatives in the GI space,” Vitt said.
The company has not decided on the exact path it will take forward in UC, however, which could include developing a different formula or a closely related derivative with a longer half-life.
New York City-based Immunic is a clinical-stage biotech developing oral, small molecule therapies for chronic inflammatory conditions and autoimmune diseases. The company had $116.4m in cash and equivalents as of 31 December, a cash runway management said could fund operations into the fourth quarter of 2024. Finding support would be useful in heading down an expensive development path, however.
The company is also investing in another GI-focused drug candidate, IMU-856, which is in Phase I development for celiac disease, with data expected in the second quarter. Having two GI drugs in development could result in an attractive portfolio for partnering as well, he pointed.
“We have the same potential partners, which could be interested in both, and there may be also a substantial synergy there,” he said.