Ferring gets a yes, but a Seres threat is looming

Ferring is on course to have the first approved faecal transplant product in the US following yesterday’s positive adcom vote. The panel voted 13 to four that RBX2660 was effective as a therapy for Clostridioides difficile infections that do not respond to antibiotics, and 12 to four, with one abstention, that it was safe. The main support for the application came from the Punch CD2 and Punch CD3 trials, in which RBX2660 showed a response rate 12% higher than placebo. The adcom nod bodes well for Seres, which this month filed its rival microbiome therapeutic SER-109. SER-109 showed a greater treatment effect in its pivotal trial, albeit in a more refractory population; it is also an oral formulation versus Ferring’s enema agent. And Seres has a powerful partner in Nestle, making it a major threat to Ferring. Other rivals are not doing so well: Finch is in financial trouble after Takeda handed back rights to two microbiome projects targeting inflammatory bowel disease. The pivotal trial of its C diff project, CP101, remains on clinical hold. Meanwhile, Destiny’s attempts to find a partner for NTCD-M3 have not yet borne fruit.