dm+d

Unassigned

New Medicines

Clostridium difficile infection - prevention of recurrence

Information

Faecal Microbiota for Transplantation (FMT) product
Ferring
Ferring

Development and Regulatory status

None
None
Recommended for approval (Positive opinion)
Sep 22The FDA´s Vaccines and Related Biological Products Advisory Committee voted 13 to 4 that Ferring´s data demonstrated RBX2660 is effective at reducing recurrence of C.difficile after antibiotic treatment. RBX2660 holds Fast Track, Orphan and Breakthrough Therapy designations in the US [16].
Jan 21Still on company pipeline (PIII trials). [12]
Jan 19On company pipeline (PIII trials). [8]
Oct 15FDA grant Breakthrough Therapy status for RBX2660 for treatment of recurrent C diff infection [1].

Category

Immunomodulator. RBX2660 is a suspension in a ready-to-use enema formulation that contains live microbes designed to rebuild a healthy intestinal microbiome, known as a FMT (Faecal Microbiota for Transplantation) product.
A total of 13,286 cases of C.difficile infection were reported by hospitals in 2017-18, an increase of 3.4% from 2016/17 and a decrease of 76.1% from 2007/08.[9]
Clostridium difficile infection - prevention of recurrence
Rectal

Trial or other data

Oct 21Ferring presents data on RBX 2660 for its five trials- PUNCH CD, PUNCH CD2, PUNCH CD Open Label, PUNCH CD3 and PUNCH CD3-OLS (total n= 723 pts aged ≥18). RBX2660 demonstrated consistent safety, efficacy and durability. RBX 2660 consistently reduced the recurrence of C. difficile infection (CDI), with up to 78.9% remaining recurrence-free for 8 weeks post treatment (defined as treatment success). RBX 2660 significantly increased gut bacteria associated with health and decreased gut bacteria associated with CDI pathology. Pts reporting a treatment-emergent adverse event in the drug group vs standard of care + placebo were similar. Most events were mild-moderate, with no potentially life-threatening issues. (15)
May 21PIII PUNCH CD3 clinical trial met its primary endpoint, demonstrating superior efficacy and consistent safety of single-dose RBX2660 in reducing recurrence of Clostridioides difficile infection (CDI) over placebo [14].
Jan 21No data from PUNCH CD3 study yet. [13]
May 20Positive topline data from ongoing PIII randomised, multicentre, double-blinded, placebo-controlled PUNCH CD3 trial (NCT03244644, n=270). The trial met the primary goal with a lower percentage of pts receiving RBX2660 to prevent recurrent C. diff in 8 weeks becoming infected vs. placebo. Full data are anticipated in H2 2020. [11]
Jan 20PIII PUNCHCD3 study (NCT03244644) still recruiting with an estimated primary completion date of June 2020.[10]
Jan 19PIII PUNCHCD3 study (NCT03244644) still recruiting with an estimated primary completion date of June 2019.[7]
Jan 19Data from PIII study (NCT02299570; PUNCH CD 2) show that the efficacy of RBX2660 vs. placebo 8 Weeks post-treatment (defined as absence of C. difficile diarrhea without the need for retreatment at 56 days after administration of the last assigned study enema) was signficantly greater in the RBX2660 gps. Efficacy was acheived in 61%, 45.5% and 66.7% in pts given 2 enemas of RBX2660 or placebo or one of each - all given 7 days apart respectively. Final adverse events will be reported by January 2019 when final analysis has been completed.[6]
Apr 18PIII PUNCHCD3 trial is still recruiting. Collection of primary outcome data expected to complete Sep 18 [5].
Jul 17PIII trial to evaluate the safety and efficacy of RBX 2660 for prevention of recurrent CDI starts (NCT03244644; PUNCHCD3). The primary endpoint will compare proportion of subjects preventing recurrent CDI for eight weeks, following administration of RBX 2660 compared with a placebo. The randomised, double-blind trial is designed to enrol approximately 270 patients in US & Canada. Data from the trial is expected to support submission of a BLA to the US FDA [4].
Nov 14Rebiotix initiated PIIb (NCT02299570; PUNCH CD 2) double-blind, placebo-controlled, randomised trial to evaluate efficacy and safety of RBX2660 for treating C.diff infection. The trial is expected to recruit 117 patients in the US and Canada [3].
Oct 14Rebiotix report results from PII (PUNCH CD; NCT01925417) open-label study. The primary objective was to assess safety, and secondary objectives included efficacy, quality of life, and cost-effectiveness of the therapy. A total of 40 patients were enrolled of whom 34 received at least a single dose of the drug administered through enema; a second dose was given only in cases where infection recurred in less than 8 weeks after first dose. RBX2660 showed an overall 87.1% efficacy in patients with C. diff infection [3].

Evidence based evaluations