Aileron Therapeutics Reports First Quarter 2020 Financial Results and Provides Corporate Update
Enrollment completed in the dose optimization part of the ongoing Phase 1b/2 clinical trial of ALRN-6924 as a chemoprotection agent in cancer patients
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Scheduled to report interim results from the dose optimization part of the Phase 1b/2 trial 2nd Quarter 2020, and planning final data readout in the fourth quarter of 2020
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Company implemented measures to reduce operating expenses to extend its cash runway to first quarter 2021
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“We continue to advance ALRN-6924 as a chemoprotection agent for cancer patients, even as the world continues to face the ongoing coronavirus pandemic. We are extremely grateful to our clinical trial sites, and our investigators and their teams for enabling this progress under such difficult circumstances. We have completed enrollment in the third and final cohort of the dose optimization part of our Phase 1b/2 clinical trial in which we are treating small cell lung cancer patients with ALRN-6924 twenty-four hours before topotecan, a standard of care chemotherapy, to study the impact of ALRN-6924 on chemotherapy toxicities,” said Dr. Manuel Aivado, President and CEO of
ALRN-6924 as a chemoprotection agent
The Company recently completed enrollment in the dose optimization part of its Phase 1b/2 clinical trial evaluating ALRN-6924 as an agent to protect patients with small cell lung cancer (SCLC) against chemotherapy-induced toxicity, a concept known as chemoprotection (or myelopreservation). The Phase 1b part of the study is designed to identify a dose and a schedule of ALRN-6924 administration to reduce chemotherapy toxicities such as severe anemia and thrombocytopenia resulting from topotecan. In this part of the trial, topotecan is administered daily on days 1 through 5 of every 21-day treatment cycle and ALRN-6924 is administered 24 hours before each dose of topotecan (on days 0 through 4 every 21 days). The dose optimization part of the study includes three patient cohorts, one for each dose level, and enrolled a total of 17 patients.
As previously reported, the Company was encouraged by the interim results of a data cutoff on
Aileron has now completed enrollment of its final patient cohort of ALRN-6924 at a third dose level in the dose optimization part of the trial. The Company is encouraged with the initial data that is emerging from this cohort as it supports the trends observed with the previous two cohorts.
The Company plans to commence the schedule optimization part of the Phase 1b trial in
Aileron currently plans to report interim results for the three dose levels of the dose optimization part of the trial in the 2nd quarter of 2020. The Company currently plans to report top-line final data for the dose optimization part of the trial and data for the schedule optimization part of the trial in the fourth quarter of 2020. The Company expects that these results will determine a recommended ALRN-6924 dose and schedule for subsequent trials.
The Company is monitoring carefully the effect of the coronavirus pandemic on the healthcare system and its clinical sites, which may impact the timing of these planned data announcements.
First Quarter 2020 Financial Results
Cash Position: Cash, cash equivalents and investments as of
R&D Expenses: Research and development expenses for the three months ended
G&A Expenses: General and administrative expenses were
Net Loss: Net loss was
Shares Outstanding: As of
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 the Company’s peptides allows the design of cell-permeating therapeutic agents with large molecular surfaces for optimal target binding properties, such as the Company’s lead product candidate ALRN-6924. The Company’s focus is to improve the standard of care for patients with cancer by developing safe and effective therapies that leverage the Company’s 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 the Company’s clinical trials will be conducted on the timelines 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
Source: Aileron Therapeutics, Inc.