Seres president and chief executive Eric Shaff

Seres qui­et­ly dis­clos­es it has once again al­tered plans in ul­cer­a­tive col­i­tis

A month af­ter an­oth­er set­back in its plans to treat ul­cer­a­tive col­i­tis, Seres Ther­a­peu­tics qui­et­ly dis­closed it will not move for­ward with a Phase Ib tri­al.

The move, dis­closed in an SEC fil­ing Wednes­day, puts Seres in a predica­ment as the Cam­bridge, MA biotech failed with one po­ten­tial UC drug, SER-287, last Ju­ly, and again with an­oth­er ex­per­i­men­tal drug last month.

That sec­ond at­tempt, with SER-301, was safe to pro­ceed to the place­bo-con­trolled sec­ond co­hort in a Phase Ib tri­al even though out­come da­ta from the 15 pa­tients in­di­cat­ed none of them had achieved clin­i­cal re­mis­sion af­ter 10 weeks of treat­ment, Seres said on March 1.

With that, the biotech tucked the no-go news in­to a Wednes­day pre­sen­ta­tion on its web­site.

“We are very proud of our work and sci­en­tif­ic progress and will con­tin­ue with our re­search to in­form fur­ther clin­i­cal de­vel­op­ment ef­forts in this dis­ease area. Ul­cer­a­tive col­i­tis re­mains an area of strate­gic in­ter­est for our com­pa­ny, and we be­lieve that fol­low­ing the work­streams we out­lined in this morn­ing’s dis­clo­sure could set us up bet­ter for fu­ture clin­i­cal de­vel­op­ment in UC. No lay­offs are planned as a re­sult of this de­ci­sion,” Seres pres­i­dent and chief ex­ec­u­tive Er­ic Shaff said in an emailed state­ment to End­points News.

As the com­pa­ny plots a mid-year ap­proval re­quest for its C. dif­fi­cile ther­a­peu­tic — which Seres claims would be the first FDA-green­lit mi­cro­bio­me ther­a­peu­tic — the com­pa­ny will ex­plore ways to de­vel­op treat­ments for UC based on the tri­al da­ta from SER-287 and SER-301.

“Clin­i­cal da­ta sug­gest po­ten­tial for bio­mark­er-based pa­tient se­lec­tion,” Seres re­vealed in the pre­sen­ta­tion. In March, the com­pa­ny said SER-301 led to im­prove­ments in en­do­scop­ic, stool fre­quen­cy and rec­tal bleed­ing sub-scores for some pa­tients.

In a Phase IIb study last year, Seres said SER-287 did not im­prove clin­i­cal re­mis­sion rates com­pared to place­bo. That road­block, which led Seres to close the open-la­bel and main­te­nance por­tions of the tri­al, has led to a stock slump for the biotech over the past nine months.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

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Lynn Baxter, Viiv Healthcare's head of North America

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AbCellera founder and CEO Carl Hansen (L) and Rallybio CEO Martin Mackay

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