Seres and Nestlé take on Ferring in C diff

 The pleasant surprise for Seres investors this morning was not that Vowst, the group’s pill formulation of faecal microbiota spores, secured FDA approval. It also received a generous label, which should help allay fears that its marketing partner Nestlé might walk away. Vowst, formerly called SER-109, may be used after a patient’s first recurrence of Clostridioides difficile infection (CDI), where the first was treated with antibiotics – despite Vowst’s pivotal trial enrolling patients who had had three CDI recurrences. This gives Vowst a comparable label with Ferring’s Rebyota, though that rectally administered therapy has a convenience disadvantage. The strong label should also help Seres and Nestlé extend their lead over other developers with oral projects, including Vedanta, which only this week raised a $107m venture round to start phase 3 trials. Seres has priced Vowst at $17,500, and on a call today execs said they anticipated no issues manufacturing enough product to meet demand. The stock opened up just 5%, restrained by the company’s decision to arrange a new $250m senior secured debt facility, on top of the $125m approval milestone it received from Nestlé. 

Stacking up the microbiome approaches to recurrent C difficile infection
Project	Company	Details	Status	Trial (setting)	Pbo-adj response* rate (%)
Rebyota (RBX2660)	Ferring (ex Rebiotix)	Enema; one-time dose. Consortia product; healthy donors	Approved for 1st recurrence Dec 2022	Ph2 Punch CD2, Ph3 Punch CD3 (at least 1 recurrence after a primary episode)	12**
Vowst (SER-109)	Nestlé/Seres Therapeutics	Oral; 4x daily for 3 days. Firmicutes spores; healthy donors	Approved for 1st recurrence Apr 2023	Ph3 Ecospor 3 (≥3 infections within 12mth)	28
NTCD-M3	Destiny Pharma	Oral; one bacterial clonal strain	Ph3 to start 2024, run by partner Sebela	Ph2 NCT01259726 (post 1st recurrence)	19
VE303	Vedanta Biosciences	Oral; eight bacterial clonal strains	Ph3 to start Q3 2023	Ph2 Consortium (post 2nd recurrence)	31 (high dose)
CP101	Finch Therapeutics	Oral; one-time dose. Consortia product (intact microbiome); healthy donors	Discontinued; company winding down	Ph3 Prism4 (≥3 episodes of CDI, with 2 within previous 6mth); Prism3 (recurrent CDI)	13
*Response defined as no C diff infection at wk8. **Bayesian analysis of ph2 and ph3 data. Source: Evaluate Pharma, company statements, publications & clinicaltrials.gov.  https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/seres-and-nestle-take-ferring-c-diff