Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SER-287 · 1 trial · 1 indication
Treatment-Emergent Adverse Events Incidence by Treatment, System Organ Class and Preferred Term. The treatment period with SER-287 was eight weeks. All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
Changes in the composition of the microbiome were characterized by whole metagenomic sequencing (WMS) of subjects' stool samples. Changes in the composition of the microbiome were measured by quantifying the number of unique types of spore-forming bacteria detected in subjects' stool samples after eight weeks of induction treatment versus baseline.
The stool microbiomes of SERES-101 subjects, before and after treatment with SER-287, were characterized using whole metagenomic sequencing (WMS). SER-287 drug product was also characterized using WMS. Microbiome engraftment was assessed by the number of spore-forming species in the drug product lots that were also detected in subjects' post-treatment fecal samples but not detected at baseline.
| Arm | Type | Description |
|---|---|---|
| Weekly SER-287, after Placebo Pre-Treat. | EXPERIMENTAL | Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks |
| Daily placebo, after Placebo Pre-Treat. | PLACEBO_COMPARATOR | Placebo pre-treatment, followed by once daily placebo for 8 weeks |
| Daily SER-287, after Vanco. Pre-Treat. | EXPERIMENTAL | Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks |
| Weekly SER-287, after Vanco. Pre-Treat. | EXPERIMENTAL | Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks |
| Name | Type | Description |
|---|---|---|
| SER-287 | DRUG | - |
| Placebo | DRUG | - |
| Placebo Pre-Treat | DRUG | - |
| Vancomycin Pre-Treat | DRUG | - |
Inclusion Criteria: * Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic and pathologic criteria (preferably confirmed by colonoscopy and pathology records within last 2 years or if unavailable, will need approval by medical monitor) Active mild-moderate UC as determined by ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | 627 |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
SER-287 is an investigational therapy being studied for the treatment of mild-to-moderate ulcerative colitis. It is designed to address the gastrointestinal condition by targeting the microbiome, though its exact mechanism is not fully detailed. SER-287 is currently in clinical development and has not been approved by the FDA.
SER-287 is being developed by Seres Therapeutics, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and tolerability of SER-287 in patients with ulcerative colitis. Seres Therapeutics is publicly traded under the ticker symbol MCRB.
SER-287 is in Phase 1 clinical development. A Phase 1 trial has been completed to evaluate the safety, tolerability, and microbiome dynamics of SER-287 in subjects with mild-to-moderate ulcerative colitis. The drug remains investigational and is not yet approved for commercial use.
SER-287 has been studied in a Phase 1 clinical trial with the identifier NCT02618187. This completed trial enrolled 58 participants with mild-to-moderate ulcerative colitis in the United States. The study was randomized, double-blind, and placebo-controlled, and it included adults aged 18 years and older.
SER-287 is not FDA approved. It is an investigational drug currently in clinical development for ulcerative colitis. A Phase 1 trial has been completed, but the drug has not yet received regulatory approval for any use. Further clinical studies would be needed to support a potential approval.