Drugs / SB010
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01577953 | Apr → Aug 2012 | asthma | Sterna Biologicals GmbH & Co. KG | Completed | No outcome recorded |
| Phase 1 | NCT01554319 | Apr → Aug 2012 | asthma | Sterna Biologicals GmbH & Co. KG | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-11-23 | Sterna Biologicals GmbH & Co. KG | Regulatory sterna biologicals receives approval for innovative phase II a study design in asthma combining a novel antisense-based treatment with a digital therapy sterna-biologicals.com ↗
Phase IIa proof-of-concept (POC) study with novel catalytic antisense oligonucleotide SB010 in patients with moderate to severe asthma initiated. |
| 2018-04-19 | Sterna Biologicals GmbH & Co. KG | Results sterna biologicals announces phase IIa data with SB010 published in Respiratory Research sterna-biologicals.com ↗
The study achieved its primary endpoint, demonstrating the feasibility of conducting a larger phase II trial of SB010 in patients with moderate to severe, stable COPD. |
| 2017-09-11 | Sterna Biologicals GmbH & Co. KG | Results German Center for Lung Research (DZL) successfully completes investigator-initiated study evaluating SB010 in COPD patients sterna-biologicals.com ↗
The study met its primary endpoint, confirming that, as expected, between 10 and 25% of COPD patients have elevated eosinophils in the airways (in the study 26 of 130 screened patients, 20%). |
| 2015-05-17 | Sterna Biologicals GmbH & Co. KG | Results sterna biologicals announces publication of SB010 Phase IIa results in the New England Journal of Medicine sterna-biologicals.com ↗
In the randomised, double-blind, parallel group, multi-centre Phase IIa trial (NCT 01743768), SB010 treatment over 28 days significantly improved lung function after specific allergen challenge as compared to placebo. |
| 2014-05-14 | Sterna Biologicals GmbH & Co. KG | Results sterna biologicals co-founder Prof Harald Renz to present key Phase IIa results at ATS sterna-biologicals.com ↗
SB010 attenuated the decline in mean AUC in the late phase asthmatic response by 34% compared to a 1% worsening in the placebo group (p=0.02). |
| 2014-02-21 | Sterna Biologicals GmbH & Co. KG | Results Phase IIa proof-of-concept trial meets primary and secondary endpoints sterna-biologicals.com ↗
Compared to placebo, SB010 significantly improved lung function in both the early and late phase asthmatic response. |
| 2013-07-15 | Sterna Biologicals GmbH & Co. KG | Results Bioavailability data of GATA-3-specific DNAzyme demonstrates long-lasting presence in airways of mice, rats, and dogs post inhalation sterna-biologicals.com ↗
Repeated administration did not lead to drug accumulation in plasma of dogs and rats. |
| 2012-09-11 | Sterna Biologicals GmbH & Co. KG | Results sterna biologicals successfully completes Phase I development programme of SB010 sterna-biologicals.com ↗
SB010 was safe and well-tolerated across all dose levels. |
| 2012-03-27 | Sterna Biologicals GmbH & Co. KG | Results Experimental data demonstrate that GATA-3-specific DNAzymes do not lead to unspecific immune cell activation sterna-biologicals.com ↗
No TLR-9 mediated or TLR-9 independent cell-stimulating activities of the DNAzyme were observed in any of the systems, further supporting the therapeutic potential of GATA-3- specific DNAzymes as previously reported (Sel et al., 2008). |
| 2012-02-27 | Sterna Biologicals GmbH & Co. KG | Results sterna biologicals completes first-in-man study of SB010 sterna-biologicals.com ↗
Adverse events were limited, unrelated to SB010 or its specific mechanism of action, and fully resolved by the end of the in-house study period. |
All press releases naming this drug 15 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SB010 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01554319 ↗ |
| Action | Inhibit | “By cleaving GATA-3 mRNA, hgd40 reduces specific cytokine production” NCT01554319 ↗ |
| Modality | Antisense oligonucleotide | “belongs to a new class of antisense oligonucleotide therapeutics” NCT01554319 ↗ |
| Route | Inhaled | “inhaled over 5 - 10 min” NCT01554319 ↗ |
| Target | GATA3 | “By cleaving GATA-3 mRNA” NCT01554319 ↗ |