Germany's 4SC misses mark in key RA drug trial, CEO keeps faith

Falling short of its primary goal in a mid-stage study for an oral drug in rheumatoid arthritis patients, German biotech 4SC ($VSC) is keeping its chin up in pursuit of a partner to take the experimental drug forward in other diseases.

With lots of interest in oral alternatives to injected drugs, 4SC CEO Ulrich Dauer was hoping that results of its mid-stage study in RA patients would provide data to help land a partnership with a pharma for its experimental pill vidofludimus. Dauer voiced his high hopes for the trial last month in a Bloomberg article. Ultimately, however, the trial fell short of its primary efficacy goal in the study, which compared patients on the experimental pill and methotrexate background therapy with those on methotrexate background therapy and a placebo, according to topline data the firm released this week.

While there was a significant improvement in response in the vidofludimus groups at weeks two and eight of the study, the group taking the 4SC pill didn't show a significant response after 13 weeks, the study's primary endpoint. The randomized, double blind study involved 244 patients, according to ClinicalTrials.gov.

Dauer said in a statement that the pursuit continues at his company for a partner to help further develop the drug. He added: "We will continue our efforts for this compound in (irritable bowel disease) and potentially other autoimmune indications such as lupus and psoriasis. Our Phase IIa trial in IBD achieved an excellent response rate of 88.5 percent and met the primary endpoint, both in Crohn's disease and ulcerative colitis patients. We feel this indication addresses an area of high unmet medical need that continues to be commercially attractive to potential partners and warrants the further development of vidofludimus based on the promising trial results."

Still, RA patients can expect the industry to continue to shoot for new oral meds for their disease, which involves the immune system attacking joints and is typically treated with expensive injected drugs such as Amgen's Enbrel and Abbott's Humira. Pfizer, for one, sees blockbuster potential in its late-stage experimental pill for RA called tofacitinib. Rigel and partner AstraZeneca are also in the final stages of developing another RA pill, fostamatinib.

- here's the 4SC's release
- see the RTTNews report

Related Articles:
German contender chases Pfizer in oral RA drug pursuit
Pfizer's potential blockbuster RA drug reports Phase III success

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