Synthetic Biologics, Inc.NYSEMKT
Fri, Nov. 18, 12:02 PM
- Synthetic Biologics (SYN +1.6%) public offering of 25M shares of common stock and warrants to purchase up to 50M shares of common at a combined price of $1 has closed. Net proceeds should be ~$23.3M.
- Underwriters over-allotment is an additional 3.75M shares of stock and warrants to purchase up to 7.5M shares.
Tue, Nov. 15, 12:43 PM
Tue, Nov. 15, 11:01 AM
Tue, Nov. 15, 10:14 AM
- Synthetic Biologics (SYN -38.5%) prices its public offering of 25M shares of common stock and warrants to purchase 50M shares of common at a combined price of $1.
- Underwriters over-allotment is an additional 3.75M shares of stock and warrants to purchase up to 7.5M shares. Closing date is November 18.
Tue, Nov. 15, 9:17 AM
Mon, Nov. 14, 4:43 PM
Mon, Nov. 14, 12:41 PM
Tue, Nov. 1, 8:51 AM
Tue, Nov. 1, 7:00 AM
Thu, Oct. 6, 9:14 AM
Tue, Sep. 20, 9:21 AM
- Synthetic Biologics (NYSEMKT:SYN) announces that following the completion of a previously planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been completed in its Phase 2b randomized, placebo-controlled, proof-of-concept clinical trial assessing SYN-004 (ribaxamase) for the prevention of Clostridium difficile (C. diff) infection. Top-line data should be available in Q1 2017.
- SYN-004 (ribaxamase) is a first-in-class oral enzyme designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome.
- Successful enrollment of 413 patients has occurred exceeding the planned target of 372 outlined per the study protocol.
Wed, Aug. 3, 4:06 PM
Mon, May 23, 8:04 AM
- Additional data from two previously reported Phase 2 trials, Study 1 and Study 2, assessing Synthetic Biologics' (NYSEMKT:SYN) lead product candidate, SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C) show a positive effect on reducing breath methane and improving spontaneous bowel movements. The data were presented yesterday during a poster session at Digestive Disease Week in San Diego, CA.
- Study 1 (n=63) was a randomized, double-blind, placebo-controlled 4-week trial comparing 21mg and 42mg of SYN-010 to placebo. Study 2 (n=54) was an open-label 8-week trial in patients who completed Study 1. Both assessed the change from baseline in breath methane, stool frequency and abdominal pain and bloating at Weeks 1,4,8 and 12 in IBS-C patients with breath methane greater than 10 parts per million at screening.
- The increase in the percentage of monthly responders from Study 1 (Day 1) to Study 2 (Day 84) was 47% for SYN-010 21mg/42mg, 33% for SYN-010 42mg/42 mg and 46% for placebo/SYN-010 42 mg. All three groups also showed clinically meaningful reductions in IBS-Symptom Severity Scores from Study 1 to Study 2 (the p values imply statistical significance).
- Data from all patients who completed both studies and who received the 42 mg dose of SYN-010 showed an inverse correlation (p=0.026) between breath methane area under the curve and complete spontaneous bowel movements. Subjects in Study 1 who received SYN-010 used 60% less rescue medication (bisacodyl 5mg) compared to placebo.
- The company plans to have an end-of-Phase 2 meeting with the FDA this summer. Phase 3 studies should commence later this year.
- Management will host a conference call this morning at 8:30 am ET to discuss the results.
- Previously: Synthetic Bio's IBS-C candidate successful in second mid-stage study; shares up 11% after hours (Jan. 19)
Mon, May 16, 8:38 AM
- Micro cap Synthetic Biologics (NYSEMKT:SYN) is up 8% premarket on increased volume in response to its announcement of positive top-line results from a second Phase 2a study assessing the ability of SYN-004 to protect the gut microbiome from the unintended effects of certain IV beta-lactam antibiotics, specifically the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms, in 14 patients with functioning ileostomies (opening in the belly for waste removal).
- The study evaluated the effect of a 150 mg dose of SYN-004 to degrade ceftriaxone when administered as monotherapy and in combination with the proton pump inhibitor esomeprazole. The results, consistent with the first Phase 2a completed last year, showed the antibiotics were degraded to near or below detectable levels in the patients' intestinal chyme without affecting the antibiotic level in the bloodstream.
- A 210-subject Phase 2b study evaluating the ability of SYN-004 to prevent CDI and AAD in patients hospitalized with a lower respiratory tract infection and receiving IV ceftriaxone is ongoing. An interim analysis of blinded data by the independent Data Monitoring Committee should be available this summer.
- SYN-004 is an oral enzyme tablet that is co-administered with the antibiotics. By degrading beta-lactams, it helps maintain the normal balance of the gut microbiome and and prevent CDI and AAD.
- Previously: Synthetic Bio's SYN-004 successful in mid-stage study; shares up 5% premarket (Dec. 1, 2015)
Fri, May 6, 12:45 PM
Fri, May 6, 9:11 AM