Drugs / SQ109
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT01358162 | Nov 2010 → Feb 2011 | tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00866190 | Apr → Nov 2009 | multidrug-resistant tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT01585636 | Sep 2006 → Feb 2007 | tuberculosis | Sequella, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01874314 | ? → Dec 2015 | tuberculosis | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT01785186 | Apr 2013 → Sep 2014 | pulmonary tuberculosis | Michael Hoelscher | Completed | Met primary |
| Phase 2 | NCT01252108 | Mar 2012 → Aug 2015 | Helicobacter pylori infectious disease | Sequella, Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT01218217 | Nov 2010 → Sep 2011 | pulmonary tuberculosis | Michael Hoelscher | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2017-03-21 | Sequella, Inc. | Results Infectex Announces Positive Phase 2b-3 Clinical Trial Results of SQ109 for the Treatment of Multidrug-Resistant Pulmonary Tuberculosis sequella.com ↗
Both the Intent to Treat (ITT) and Per Protocol (PP) patients treated with SQ109 -containing regimens showed statistically significant improvement in clearance of lung bacteria. |
| 2012-07-26 | Sequella, Inc. | Regulatory Maxwell Biotech Venture Fund's Portfolio Company, Infectex, Receives Russian Regulator's Approval to Conduct Pivotal Clinical Trial for Sequella's Antibiotic, SQ109, for Tuberculosis sequella.com ↗
“We are extremely pleased that our corporate partner has achieved regulatory clearance to allow further study and potential commercialization of SQ109 in patients desperate for new therapeutic options,” said Dr. Carol Nacy, CEO of Sequella. |
| 2010-12-06 | Sequella, Inc. | Regulatory Sequella Files IND and Receives FDA Go-ahead for Phase 2 Trial of SQ109 in Helicobacter pylori -associated Duodenal Ulcers sequella.com ↗
Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of infectious diseases, announced it has successfully filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) to test SQ109 in patients suffering from H. pylori-related duodenal ulcers, and can now begin Phase 2 studies. |
| 2010-07-26 | Sequella, Inc. | Results Two New Tuberculosis (TB) Drugs Show Significant Synergy In Vitro sequella.com ↗
The results of the studies, a research collaboration between Sequella and Tibotec, demonstrated that the combination of SQ109 with TMC207 decreased the TMC207 minimal inhibitory concentration (MIC) by 4- to 8-fold for the etiologic agent of TB, Mycobacterium tuberculosis. |
| 2008-10-28 | Sequella, Inc. | Results Sequella Presents Data on Synergy Between Investigational New TB Drugs SQ109 and TMC207 sequella.com ↗
SQ109 and TMC207 in combination were either synergistic or additive with the various MTB strains and showed increased rate of killing, enhanced post antibiotic effect and intracellular killing activity. |
| 2007-10-22 | Sequella, Inc. | Regulatory Sequella Lead Drug Compound SQ109 Receives Orphan Drug Status from the US FDA and Orphan Medicinal Product Designation from the European Medicines Agency for the Treatment of Tuberculosis sequella.com ↗
Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat diseases of epidemic potential, announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) independently reviewed Sequella lead drug compound, SQ109, and both agencies granted SQ109 orphan drug status for the treatment of tuberculosis. |
| 2007-05-03 | Sequella, Inc. | Results Sequella Lead Drug SQ109 Completes Phase 1A Trial sequella.com ↗
The study found that doses of SQ109 up to 300 mg, the highest dose tested, were safe and well tolerated, with no serious adverse effects reported at any dose. |
| 2007-01-22 | Sequella, Inc. | Regulatory Sequella Receives FDA Fast Track Status for TB Drug sequella.com ↗
Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing improved treatment paradigms for diseases of epidemic potential, today announced it has received Fast Track designation from the U. S. Food and Drug Administration (FDA) for SQ109, the company’s proprietary lead drug candidate for treatment of pulmonary tuberculosis (TB). |
| 2006-09-25 | Sequella, Inc. | Results Sequella to Present at 2006 ICAAC Conference sequella.com ↗ |
| 2005-11-14 | Sequella, Inc. | Results Sequella Presentation at the 45th ICAAC Meeting, Washington, DC sequella.com ↗
This study demonstrated that the Sequella anti-TB compound called SQ109 improved outcome and shortened therapy duration when substituted for Ethambutol in combination with Isoniazid and Rifampin in the initial phase of TB treatment. |
All press releases naming this drug 22 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SQ109 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01874314 ↗ |
| Known as | NSC-722041 | ChEMBL registry synonym — accepted as the source's own label CHEMBL561057 ↗ |
| Modality | Small molecule | “SQ109 is a new, small molecule antibiotic with characteristics that make it particularly attractive to evaluate against H. pylori.” NCT01252108 ↗ |
| Route | Oral | “oral SQ109” NCT00866190 ↗ |