Synthetic Biologics Under The Microscope
Jerad W. Starr • 61 Comments
Jerad W. Starr • 61 Comments
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
Fri, May 6, 9:07 AM
- Micro cap Synthetic Biologics (NYSEMKT:SYN) is up 21% premarket on increased volume on the heels of yesterday's announcement of Q1 results. Its cash balance has eroded to $15.1M, but a Phase 3 study of lead product candidate SYN-010 in irritable bowel syndrome is on tap for H2 following an End-of-Phase 2 meeting with the FDA this summer. Investors are bullish on SYN-010's prospects considering Phase 2 results showed treatment with the modified-release lovastatin significantly reduced methane production and IBS symptoms.
Thu, May 5, 4:06 PM
Fri, Mar. 11, 7:24 AM
- Synthetic Biologics (SYN) FY15 results: Revenues: $0; R&D Expense: $32.9M (+126.9%); SG&A: $8.1M (+35.0%); Operating Loss: ($41M) (-100.0%); Net Loss: ($43.7M) (-120.7%); Loss Per Share: ($0.54) (-68.8%); Quick Assets: $20.8M (+18.9%).
- No guidance given.
Thu, Mar. 10, 4:30 PM
- Synthetic Biologics (NYSEMKT:SYN): FY'15 EPS of -$0.54 beats by $0.01.
- Shares -10.2% AH.
Tue, Mar. 1, 9:19 AM
Fri, Feb. 26, 9:17 AM
- Gainers: RRM +49%. SUNE +31%. AMTG +31%. SGMS +27%. STMP +26%. GOL +19%. SPLK +17%. JCP +16%. HLF +13%. BIDU +11%. SYN +10%. GLBL +8%. WLL +9%. FCX +7%. CHK +7%. PANW +8%. NRF +6%. TCK +6%. MRO +6%. KHC +6%. GRPN 5%. HLT 5%.
- Losers: RJET -83%. PPHM -60%. CARA -36%. WTW -28%. SWN -14%. GG -11%. FOLD -9%. RBS -8%. MNKD -6%. ARI -5%.
Wed, Feb. 17, 12:03 PM
- The USPTO issues a Notice of Allowance for a patent application (No. 14/211,197) from Cedars-Sinai Medical Center (CSMC) covering the use of a variety of compounds and patient screening technology related to Synthetic Biologics' (SYN +11.2%) SYN-010, its candidate for the treatment of irritable bowel syndrome with constipation (IBS-C). The patent, when issued, includes SYN-010's active ingredient. It will be owned by CSMC and exclusively licensed to SYN. SYN-010's patent protection extends to at least 2034.
- SYN-010 is a proprietary, modified-release formulation of the statin, lovastatin, which is intended to reduce methane production by certain gut microorganisms (M. smithii), believed to be the main cause of pain, bloating and constipation associated with IBS-C. SYN-010 is designed to act primarily in the intestinal lumen while avoiding systemic absorption, thereby targeting the major cause of IBS-C.
Tue, Feb. 2, 12:47 PM
Tue, Feb. 2, 9:17 AM| Tue, Feb. 2, 9:17 AM | 5 Comments
Tue, Feb. 2, 8:49 AM
- Based on an independent third party analysis of the results from a failed Phase 2 clinical trial assessing Trimesta (oral estradiol) and Teva's (NYSE:TEVA) COPAXONE (glatiramer acetate injection) in women with relapsing-remitting multiple sclerosis (RRMS), Synthetic Biologics (NYSEMKT:SYN) decides to terminate its license and clinical trial agreements related to the drug.
- Analyses from two clinical research organizations confirmed that Trimesta failed to demonstrate a statistically valid treatment effect over and above COPAXONE.
- CEO Jeff Riley says, "We are disappointed with the outcome of the data analyses which did not demonstrate statistically significant treatment effects in this study. We intend to focus the Company's resources on its other programs, including our two Phase 2 gut microbiome programs which have both demonstrated top-line clinical results."
- Shares are down 17% premarket on increased volume.
Wed, Jan. 20, 12:45 PM
Synthetic Biologics, Inc. is a clinical stage company, which develops therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. Its products portfolio includes SYN-004 and SYN-010. The SYN-004, which is designed to protect the gut microbiome from the effects of... More
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