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Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) is a clinical-stage biopharmaceutical company focused on the development of novel RNA-modulating drug candidates designed to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are genetic mutations that disrupt protein synthesis, leading to severe genetic disorders. With over 1,800 identified rare diseases caused by these mutations, Eloxx is at the forefront of innovative genetic therapies.
The company's lead product candidate, ELX-02, is a small molecule drug designed to restore production of full-length functional proteins. Currently in Phase 2 clinical development, ELX-02 has shown promise in treating Alport syndrome, a genetic disorder characterized by kidney disease, hearing loss, and eye abnormalities.
Recent advancements include confirmation of ELX-02's disease-modifying potential in Alport syndrome, with positive results from patient biopsies in clinical trials. Eloxx has also submitted an Investigational New Drug (IND) application to the U.S. FDA for ELX-02, aiming to include U.S.-based sites in its pivotal trials.
Additionally, Eloxx is developing ZKN-013, a TURBO-ZM™ based molecule for treating recessive dystrophic epidermolysis bullosa (RDEB) and other genetic conditions. The company has initiated strategic partnerships and aims to begin patient dosing by the end of 2023.
Financially, Eloxx reported a net loss of $3.6 million for Q3 2023 but has shown a decrease in overall R&D and administrative expenses compared to the previous year. The company is focused on improving its liquidity position and raising additional capital to fund operations through 2023 and beyond.
Eloxx continues to leverage its TURBO-ZM™ chemistry platform to develop novel Ribosome Modulating Agents (RMAs) and maintain its commitment to addressing the unmet medical needs of patients with rare genetic disorders. For the latest updates and detailed information, visit www.eloxxpharma.com.
Eloxx Pharmaceuticals (NASDAQ: ELOX) has announced a fifth treatment arm in its ongoing Phase 2 clinical trial for ELX-02, aimed at treating cystic fibrosis (CF) in patients with at least one G542X allele. This addition evaluates the safety of ELX-02 in combination with Kalydeco (ivacaftor). Positive preclinical synergy between the two drugs suggests enhanced clinical outcomes. Results from the first four arms are anticipated in the second half of 2021. The trial spans multiple countries, with no serious drug-related adverse events reported thus far.
Eloxx Pharmaceuticals (NASDAQ: ELOX) has acquired Zikani Therapeutics in an all-stock transaction, aiming to lead in ribosomal RNA-targeted therapies for rare diseases and oncology. The merger enhances the potential of ELX-02, currently in Phase 2 for cystic fibrosis, and introduces new therapeutic opportunities for Recessive Dystrophic Epidermolysis Bullosa and related conditions. Zikani's TURBO-ZM™ platform will accelerate drug development. Approximately 7.6 million shares will be issued to Zikani stockholders, granting them 16% ownership of the combined entity.
Eloxx Pharmaceuticals (NASDAQ: ELOX) reported financial results for Q4 and FY 2020, noting cash reserves of $24.7 million to support operations. The company is set to release top-line data from its Phase 2 cystic fibrosis trials in H1 2021, expanding sites internationally, including Australia and Canada. The Cystic Fibrosis Foundation increased funding, and dose escalation has been approved by independent committees without serious adverse events. Eloxx aims to demonstrate the efficacy of ELX-02, its investigational drug, in treating cystic fibrosis.
Summary:
Eloxx Pharmaceuticals (NASDAQ: ELOX) announced a conference call and webcast scheduled for March 11, 2021, at 4:30 p.m. ET to discuss its Q4 and full-year 2020 financial and operational results. The company focuses on developing RNA-modulating therapies for diseases caused by nonsense mutations, with its lead candidate, ELX-02, targeting cystic fibrosis. Eloxx aims to restore functional protein production in affected patients. This press release includes forward-looking statements regarding the company's development plans and potential risks associated with its drug candidates.
Eloxx Pharmaceuticals, Inc. (NASDAQ: ELOX) announced the publication of a scientific manuscript in the Journal of Cystic Fibrosis, detailing the results of ELX-02 in restoring CFTR function in human-derived intestinal organoids. The findings indicate that ELX-02 increased CFTR activity in a dose-dependent manner, showing a 5-fold increase in CFTR mRNA compared to vehicle treatment. The study supports the ongoing Phase 2 clinical trial for patients with G542X nonsense alleles, who currently have limited treatment options. Top-line data is expected in the first half of 2021.
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.
Eloxx Pharmaceuticals announced the publication of a scientific manuscript detailing the results of its Phase 1 renal impairment trial for ELX-02 in patients with nephropathic cystinosis. The study found that ELX-02 was well tolerated and demonstrated a consistent pharmacokinetic profile across varying degrees of renal insufficiency. This research enables targeted individualized dosing of ELX-02, supporting ongoing Phase 2 programs in both cystic fibrosis and autosomal dominant polycystic kidney disease. The findings were published in the Journal of Clinical Pharmacology.
Eloxx Pharmaceuticals (NASDAQ: ELOX) announced an expansion of its agreement with the Cystic Fibrosis Foundation, now including global funding for its Phase 2 clinical trial program for ELX-02, targeting cystic fibrosis. The trials, sanctioned by relevant health networks in Europe and the U.S., aim to address significant unmet medical needs. The company anticipates reporting top-line data in the first half of 2021, contingent on COVID-19 disruptions. ELX-02 has received orphan drug designations from the FDA and EMA, indicating its potential in treating rare diseases.
Eloxx Pharmaceuticals (NASDAQ: ELOX) announced that CEO Dr. Gregory Williams will participate in the Piper Sandler 32nd Annual Virtual Growth Conference. The fireside chat will be accessible to registered attendees from November 23 at 10:00 AM ET to December 3, 2020. One-on-one investor meetings are scheduled for December 1, 2020, through Piper Sandler. Eloxx is developing novel therapeutics for cystic fibrosis and other diseases caused by nonsense mutations, with their lead product candidate, ELX-02, currently in early clinical development.
Eloxx Pharmaceuticals reported its financial results for Q3 2020, revealing a net loss of $6.6 million, down from $12.9 million year-over-year. Cash reserves stand at $30.6 million, sufficient through 2021. The independent Safety Review Committees have approved dose escalation in Phase 2 cystic fibrosis trials, with top-line data expected in H1 2021, contingent on pandemic-related disruptions. Preclinical studies in ADPKD and inherited retinal disorders are progressing. Eloxx's lead compound, ELX-02, is focused on treating cystic fibrosis and is presently in clinical trials.
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