Articles from Eloxx Pharmaceuticals

Data from Eloxx’s proof-of-concept trial in patients with nonsense mutation Alport Syndrome (NMAS) presented in late-breaking presentation at American Society of Nephrology (ASN) Kidney Week

First two subjects dosed in Phase 1 clinical trial of ZKN-013; ZKN-013 is being developed for the potential treatment of rare dermatological and other diseases associated with nonsense mutations

ELX-02 Granted Orphan Drug Designation (ODD) from U.S. Food and Drug Administration (FDA) for Treatment of Alport Syndrome

BARCELONA, Spain and WATERTOWN, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- Almirall, S.A. (BME:ALM) and Eloxx Pharmaceuticals, Inc. (OTC: ELOX) announced today that the companies have entered into an exclusive license agreement for the asset ZKN-013. Under the agreement, Almirall obtains global rights to develop and commercialize ZKN-013, including for the use in orphan dermatological diseases. ZKN-013 is a potentially promising oral, nonsense mutation readthrough drug, which enables the host cells to produce functional proteins which counteract the root cause of these rare dermatological and potentially other diseases.

Kidney morphology improved in all three patients with protein re-expression consistent with disease regression in its Phase 2 open-label clinical trial of ELX-02 for the treatment of Alport Syndrome

ELX-02 treatment improved podocyte foot process effacement in all three patients by an average of 60% based on a blinded kidney biopsy analysis by NIPOKA GmbH

WATERTOWN, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that it has entered into a definitive agreement for the issuance and sale of an aggregate of 380,590 of its shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $5.255 per share (or common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, Eloxx has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 380,590 of its shares of common stock. The warrants will have an exercise price $5.13 per share, will become exercisable immediately upon issuance and have a term of five and one-half years from the date of issuance. The offering is expected to close on or about September 20, 2023, subject to the satisfaction of customary closing conditions.

Highly regarded renal pathologist and transmission electron microscopy (TEM) expert independently confirms previously reported qualitative assessment by Mayo Clinic of TEM biopsy scans

Investigational New Drug (IND) application submitted to U.S. Food and Drug Administration (FDA) for ELX-02 for the treatment of Alport syndrome with nonsense mutations

Announced today that all 3 patients (100% response rate) treated with ELX-02 showed an improvement in podocyte foot process effacement post-treatment in kidney biopsies assessed by electron microscopy, demonstrating the disease-modifying effect of ELX-02

All three patients (100% response rate) treated with ELX-02 showed an improvement in podocyte foot process effacement post-treatment in kidney biopsies assessed by electron microscopy demonstrating the disease modifying effect of ELX-02

WATERTOWN, Mass., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that it received notice from the Nasdaq Listing Qualifications Panel (the “Hearings Panel”) of The Nasdaq Stock Market LLC (“Nasdaq”) that it has determined to extend the exception granted on June 2, 2023 to Eloxx Pharmaceuticals, Inc. (the “Company”) to regain compliance with Listing Rule 5550(b)(2), which requires a listed company to have at least $35 million in market value of listed securities in order to qualify for continued listing on the Nasdaq Capital Market, until October 9, 2023, following a request for an extension and update submitted by the Company on July 27, 2023.

Publication titled “A Novel Class of Ribosome Modulating Agents Exploits Cancer Ribosome Heterogeneity to Selectively Target the CMS2 Subtype of Colorectal Cancer” published in Cancer Research Communications

Alport syndrome is a rare progressive hereditary glomerular kidney disease caused by variants in COL4A and patients have significant unmet medical needs, with no disease modifying treatments currently available

Globally renowned Alport syndrome experts will provide key insights

Data from RaDaR natural history study indicates that Alport syndrome patients with autosomal recessive COL4A4 mutations have severest disease, with a more rapid progression to kidney failure

Company continuing to prepare for advancement of clinical assets, including ELX-02 pivotal study in Alport Syndrome and ZKN-013 Phase 1 study

Patient treated in trial achieved a remission after eight weeks of treatment, demonstrating a significant reduction in proteinuria

Topline results to include biopsy results for the Phase 2 clinical study evaluating ELX-02 for the potential treatment of Alport syndrome expected in first half of 2023; meaningful protein reduction has been observed in one patient to date

ZKN-013 is in development for potential treatment of recessive dystrophic and junctional epidermolysis bullosa (RDEB and JEB) and Familial Adenomatous Polyposis (FAP)

Three patients now dosed in Phase 2 clinical study evaluating ELX-02 for the treatment of Alport syndrome; encouraging initial reduction in proteinuria has been observed in one patient to date

ZKN-013 in development for treatment of recessive dystrophic epidermolysis bullosa (RDEB) and junctional epidermolysis bullosa (JEB)

WATERTOWN, Mass., March 06, 2023 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (NASDAQELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today announced that it will present at the Oppenheimer 33rd Annual Healthcare Conference on Monday, March 13th at 12:00 PM ET.

Topline results expected in first half of 2023

Topline results expected in first half of 2023

ELOX common stock expected to begin trading on a split-adjusted basis on December 2, 2022

Started proof-of-concept Phase 2 clinical trial with ELX-02 in up to eight Alport syndrome patients with nonsense mutations; topline results expected in the first half of 2023

Trial sites now open in Australia and the United Kingdom