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. 

Stacking up the microbiome approaches to recurrent C difficile infection
Project Company Details Status  Trial (setting) Pbo-adj response* rate (%)
RBX2660 Ferring
(ex Rebiotix)
Enema; one-time dose. Consortia product; healthy donors Positive adcom Sep 2022 Ph2 Punch CD2, Ph3 Punch CD3 (at least one recurrence after a primary episode) 12**
SER-109  Nestlé/Seres
Oral capsule; 4x daily for 3 days. Firmicutes spores; healthy donors BLA filed Sep 2022 Ph3 Ecospor 3 (≥3 CDI episodes within 12 mo) 28
CP101 Finch
Oral capsule; one-time dose. Consortia product (intact microbiome); healthy donors Prism4 on clinical hold; Prism3 (ph2) reported  Ph3 Prism4 (≥3 episodes of CDI, with 2 within previous 6 mo); Prism3 (recurrent CDI) 13
VE303 Vedanta
Oral; ph3 dose unconfirmed. Eight bacterial clonal strains Ph3 to start in 2022 Ph2 Consortium (post second recurrence) 31 (high dose)
NTCD-M3 Destiny
Oral, high dose to enter ph3. One bacterial clonal strain Preparing for ph3, in talks with licensing partners Ph2 NCT01259726 (post first recurrence) 19
RBX7455 Ferring
(ex Rebiotix)
Oral; ph3 dose unconfirmed. Consortia product, healthy donors Ph3 stalled, details undisclosed
*Response defined as no C diff infection at wk8, **Bayesian analysis of Ph2 and Ph3 data. Source: Evaluate Pharma, company statements, publications & clinicaltrials.gov. 

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