STOCK TITAN

Eloxx Announces Publication of Scientific Manuscript on ELX-02 in the Journal of Clinical Pharmacology in Drug Development

Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Neutral)
Tags
Rhea-AI Summary

Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) announced the publication of a scientific manuscript detailing the results of a Phase 1B trial for its drug candidate ELX-02, aimed at treating cystic fibrosis. Published in the Journal of Clinical Pharmacology in Drug Development, the study found no serious adverse events, supporting the drug's favorable safety profile. Dr. Goddeeris expressed optimism regarding ongoing Phase 2 trials and anticipates top-line data in the first half of 2021. Eloxx focuses on RNA-modulating therapies for diseases caused by nonsense mutations.

Positive
  • Successful publication of Phase 1B trial results indicates solid safety profile for ELX-02.
  • No severe adverse events reported, aligning with previous data supporting further development.
Negative
  • None.

Publication titled: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of ELX-02 in Healthy Subjects”

WALTHAM, Mass., Jan. 26, 2021 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc., (NASDAQ: ELOX) a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis and other diseases caused by nonsense mutations limiting production of functional proteins, today announced that a scientific manuscript titled: “A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of ELX-02 in Healthy Subjects” was published in the Journal of Clinical Pharmacology in Drug Development.

“We are very pleased that our scientific manuscript on the results of our Phase 1B multiple-ascending dose trial evaluating the safety and pharmacokinetics of ELX-02 in healthy volunteers has been published in the Journal of Clinical Pharmacology in Drug Development,” said Dr. Matthew Goddeeris, PhD, Vice President of Research, Eloxx Pharmaceuticals. “There were no severe or serious adverse events reported in the trial, which is consistent with the favorable tolerability profile demonstrated across our preclinical and clinical datasets. These data support our current Phase 2 clinical trial for ELX-02 in cystic fibrosis patients with nonsense alleles, for whom there are few, if any, treatment options available. We look forward to reporting top line data in the first half of 2021.”

Eloxx Pharmaceuticals

Eloxx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA. As a consequence, patients with premature stop codon diseases have reduced or eliminated protein production from the mutation bearing allele accounting for some of the most severe phenotypes in these genetic diseases. These premature stop codons have been identified in over 1,800 rare and ultra-rare diseases. Read-through therapeutic development is focused on extending mRNA half-life and increasing protein synthesis by enabling the cytoplasmic ribosome to read through premature stop codons to produce full-length proteins. Eloxx’s lead investigational product candidate, ELX-02, is a small molecule drug candidate designed to restore production of full-length functional proteins. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Eloxx’s preclinical candidate pool consists of a library of novel drug candidates designed to be eukaryotic ribosomal selective glycosides identified based on read-through potential. Eloxx also has preclinical programs focused on kidney diseases including autosomal dominant polycystic kidney disease, as well as rare ocular genetic disorders. Eloxx is headquartered in Waltham, MA, with operations in Rehovot, Israel and Morristown, NJ. For more information, please visit www.eloxxpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, including: the development of the Company’s read-through technology; the approval of the Company’s patent applications; the Company’s ability to successfully defend its intellectual property or obtain necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the Company’s ability to obtain applicable regulatory approvals for its current and future product candidates; the acceptance by the market of the Company’s products should they receive regulatory approval; the timing and success of the Company’s preliminary studies, preclinical research, clinical trials, and related regulatory filings; the ability of the Company to consummate additional financings as needed; the impact of global health concerns, such as the COVID-19 global pandemic, on our ability to continue our clinical and preclinical programs and otherwise operate our business effectively; as well as those discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Contact:

Barbara Ryan
203-274-2825
barbarar@eloxxpharma.com

SOURCE: Eloxx Pharmaceuticals, Inc.


FAQ

What is the significance of the ELX-02 trial results announced by Eloxx Pharmaceuticals?

The trial results indicate a favorable safety profile for ELX-02, supporting its ongoing development for cystic fibrosis.

What is the publication date of the manuscript on ELX-02?

The manuscript was published on January 26, 2021, in the Journal of Clinical Pharmacology in Drug Development.

When can investors expect top-line data from Eloxx Pharmaceuticals' Phase 2 trial for ELX-02?

Top-line data from the ongoing Phase 2 trial is expected in the first half of 2021.

What are the main goals of ELX-02 as a drug candidate?

ELX-02 aims to treat cystic fibrosis by restoring the production of functional proteins in patients with nonsense mutations.

Which diseases is Eloxx Pharmaceuticals targeting with ELX-02?

Eloxx Pharmaceuticals is targeting cystic fibrosis and other diseases caused by nonsense mutations with ELX-02.

ELOXX PHARMACEUTICALS INC

OTC:ELOX

ELOX Rankings

ELOX Latest News

ELOX Stock Data

314
2.81M
5.98%
19.59%
0.7%
Biotechnology
Healthcare
Link
United States of America
Watertown