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For those interested in #Cdiff on 8/10, @SeresTX put out results of the phase 3 trial of SER-109 (oral microbial spore complex) for recurrent CDI (rCDI)
press release: https://bit.ly/30WWZHt
full NCT detail: https://bit.ly/3fV3TkJ
1-line: 1ry endpoint
(I have
COI)
press release: https://bit.ly/30WWZHt full NCT detail: https://bit.ly/3fV3TkJ 1-line: 1ry endpoint
(I have
COI)
rCDI is a 
major unmet need in CDI
other 2 are
diagnosis
fulminant disease
major unmet need in CDIother 2 are
diagnosisfulminant disease
Established therapies for rCDI exist but have downsides (*)
selective abx (i.e. fidaxomicin) * expensive
abx tapers (vanco, fidaxo) * burdensome
passive immunotherapy (anti-toxin B mAb) * not widely available
FMT * regulatory difficulties
Thus, more options needed
selective abx (i.e. fidaxomicin) * expensiveabx tapers (vanco, fidaxo) * burdensomepassive immunotherapy (anti-toxin B mAb) * not widely availableFMT * regulatory difficulties Thus, more options needed
Back to SER-109...
what's the effect size
Outcome is 8 week recurrence
placebo - 41.3%
active - 11.1%
absolute risk reduction = 30.2%
NNT = 3.3
...so far so good
what's the effect size
Outcome is 8 week recurrence
placebo - 41.3%active - 11.1%absolute risk reduction = 30.2%
NNT = 3.3...so far so good
Patient population:
include: >18yo, >3 unformed stools x 2d, 
toxin, adequate response to standard antibiotic
: 
, fulminant, ICU, ANC<500, GI surgery, IBD & MC, chemo, XRT, FMT
include: >18yo, >3 unformed stools x 2d, toxin, adequate response to standard antibiotic: , fulminant, ICU, ANC<500, GI surgery, IBD & MC, chemo, XRT, FMT
Thoughts?
toxin: EIA picks up very 
[toxin] (>1000pg/mL) = select subset of CDI pts, 
representative (i.e. 41% recurrence=high)
SOC abx 10-21d: long tapers excluded, fair but 
representative
post-op GI excluded
IBD and even MC excluded
active cancer excluded
toxin: EIA picks up very [toxin] (>1000pg/mL) = select subset of CDI pts, representative (i.e. 41% recurrence=high) SOC abx 10-21d: long tapers excluded, fair but representative post-op GI excluded IBD and even MC excluded active cancer excluded
Final thoughts
One of 1st bacteriotherapies close to approval (novel)
Nice effect size: 1 recurrence prevented for every 3 treatments
Selected for high risk of recurrence
Excluded IBD, post-op GI surg, active cancer (common among pts at rx for rCDI)
One of 1st bacteriotherapies close to approval (novel)Nice effect size: 1 recurrence prevented for every 3 treatmentsSelected for high risk of recurrenceExcluded IBD, post-op GI surg, active cancer (common among pts at rx for rCDI)
