Eisbach Bio announces successful completion of Phase I clinical trial of nucleic acid helicase inhibitor EIS-10700 with excellent safety properties
- laura1cortesi
- 24. Mai 2024
- 2 Min. Lesezeit
MARTINSRIED, Germany, May 24, 2024 – Eisbach Bio GmbH (“Eisbach” or the “Company”), a privately-held clinical-stage biotechnology company pioneering cancer medicines leveraging synthetic lethality, has announced completion and Phase I topline results of EIS-10700. The safety, tolerability and pharmacokinetics of EIS-10700 were investigated in a first-in-human, open label, single center, single dose escalation Phase I study in Germany.
Due to the excellent safety profile obtained in GLP toxicology studies (i.e. MTD in dogs >500 mg/kg), the first cohort of trial participants were given a starting daily dose of 500 mg. The Phase I study enrolled a total of 33 patients in five groups, using escalating dose levels of EIS-10700 in fasted and fed conditions. Subjects received up to the maximum dose of 3.000 mg without a single report of dose limiting toxicity associated with the investigational agent, confirming prior preclinical findings. EIS-10700 demonstrated dose dependent plasma exposure.
“We are excited to complete our first clinical study, which demonstrated the excellent tolerability and PK of EIS-10700.” said Adrian Schomburg, CEO of Eisbach. “Based on the achieved plasma levels, we are excited to now proceed with investigating the anti-tumor efficacy of this first-in-class helicase inhibitor.”
“These results represent another milestone for our proprietary AI-supported ALLOS drug discovery engine. EIS-10700 showed that it is possible to develop safe first-in-class drug candidates targeting helicases.” said Prof. Andreas Ladurner, Founder and CSO of Eisbach. “By integrating structural biology, AI and chemistry, we can target the molecular transitions in machines that are required to reorganize nucleic acids, allowing us to power a differentiated pipeline of safe drugs on novel targets.”
About the EIS-10700 Phase 1 Clinical Trial
First-in-human, open label, single center, single and multiple dose escalation Phase I study in heathy subjects of EIS-10700 conducted in Germany. EIS-10700 is a novel small molecule helicase inhibitor. EIS-10700 is the first clinical program derived from Eisbach’s ALLOS drug discovery engine.
About Eisbach
Eisbach is at the forefront of precision oncology, developing allosteric drugs that selectively disrupt molecular machines vital for tumor genome reorganization. By combining genetic vulnerabilities with its proprietary ALLOS platform, which hits the molecular vulnerability of its cancer targets, Eisbach pioneers first-in-class therapies with fewer side effects. For more information, visit https://www.eisbach.bio/ and follow us on LinkedIn.
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