Presentation of interim results from the dose-optimization part of the Phase 1b myelopreservation study
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Final data readout from Phase 1b for both dose optimization and schedule optimization in Q4 2020
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Updated corporate presentation available on the Company’s website
WATERTOWN, Mass., April 22, 2020 (GLOBE NEWSWIRE) -- Aileron Therapeutics (ALRN) today announced plans to report interim results from their Phase 1b/2 clinical trial of ALRN-6924 in small cell lung cancer (SCLC). In this trial, ALRN-6924 is being evaluated as an agent to protect cancer patients against chemotherapy-induced toxicity, a concept known as myelopreservation or chemoprotection.
“We are pleased with the continued progress of the dose-optimization portion of our Phase 1b clinical trial in which we treat small cell lung cancer patients with ALRN-6924 twenty-four hours before topotecan, a standard chemotherapy. Emerging data from the trial puts us on track to report interim results in mid-2020, and the final data readout in the fourth quarter of 2020,” said Dr. Manuel Aivado, President and CEO of Aileron Therapeutics. “Our goal for this interim data will be to further support our belief that ALRN-6924 has a protective effect against severe chemotherapy-induced anemia and thrombocytopenia.”
The Company is currently conducting a Phase 1b/2 trial of ALRN-6924 in patients with SCLC to identify a dose and schedule of ALRN-6924 administration to reduce severe anemia and thrombocytopenia resulting from topotecan. In this trial, topotecan is administered daily on days 1 through 5 of every 21-day treatment cycle. ALRN-6924 is administered 24 hours before each dose of topotecan (on days 0 through 4 every 21 days), respectively. The Company currently plans to report final data from the Phase 1b portion of the trial in the fourth quarter of 2020. Those results will determine a recommended ALRN-6924 dose and schedule for subsequent studies.
In addition, the Company has posted an updated investor presentation on the Investors & Media section of its website (click here).
ALRN-6924 is a first-in-class dual MDM2/MDMX inhibitor that is currently being evaluated in a Phase 1b/2 clinical trial to evaluate ALRN-6924 as a chemoprotective agent to protect against chemotherapy-related toxicities.
Aileron is a clinical-stage biopharmaceutical company advancing a proprietary platform of cell-permeating alpha-helical peptides. The stabilized helical structure of our peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, resulting in drug candidates like ALRN-6924. Our current focus is to improve the standard of care for patients with cancer by developing safe and effective therapies that leverage our proprietary peptide platform. For more information, visit www.aileronrx.com, and for more information about our clinical trials please visit www.clinicaltrials.gov.
Statements in this press release about Aileron's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the Company’s strategy and clinical development plans. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Aileron’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether results obtained in preclinical and nonclinical studies and clinical trials will be indicative of results obtained in future clinical trials; whether preliminary or interim results from a clinical trial will be indicative of the final results of the trial; whether Aileron’s product candidates will advance through the clinical trial process on a timely basis, or at all; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Aileron's product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; whether the coronavirus pandemic will have an impact on the timing of our clinical development and our operations; and other factors discussed in the "Risk Factors" section of Aileron's quarterly report on Form 10-K for the period ended December 31, 2019, filed on March 30, 2020, and risks described in other filings that Aileron may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Aileron specifically disclaims any obligation to update any forward-looking statement, whether because of new information, future events or otherwise.
Richard Wanstall, SVP Chief Financial Officer
Hans C. Vitzthum
LifeSci Advisors, LLC.