Aileron Therapeutics Announces Positive Interim Results from Phase 1b/2 Clinical Trial of ALRN-6924 for the Prevention of Topotecan-induced Toxicities During Treatment for Small Cell Lung Cancer
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Observed a protective effect against severe chemotherapy-induced anemia and thrombocytopenia across all dose levels
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Management to host a conference call and webcast today at
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Key findings from the interim analysis of the Phase 1b dose optimization part of the trial are as follows:
- Patients treated with 0.3 mg/kg ALRN-6924 showed the lowest rate of NCI CTC Grade 3/4 hematological adverse events, including 17% with anemia, 33% with thrombocytopenia and 67% with neutropenia, across all treatment cycles.
- None of the patients treated with 0.3 mg/kg ALRN-6924 required transfusions of red blood cells or platelets. The expansion of the 0.3 mg/kg ALRN-6924 dose level from six to a total of 14 patients is underway.
- Across all three dose levels, patients showed NCI CTC Grade 3/4 hematological adverse events, including 24% with anemia, 35% with thrombocytopenia and 88% with neutropenia.
- Across all three dose levels, no patients experienced febrile neutropenia or NCI CTC Grade 3/4 nausea, vomiting, diarrhea or fatigue, which are severe toxicities commonly observed with topotecan-treatment in this patient population.
“Large randomized trials designed to evaluate the anti-tumor efficacy of topotecan and other drugs have historically presented safety data as physician-reported adverse events of hematological toxicity. In this study, Aileron has evaluated bone marrow toxicity based upon absolute laboratory values, which are fully objective measures when considering the toxicity of topotecan. While still preliminary, the results from our dose optimization trial show a strong chemoprotective effect on severe anemia and thrombocytopenia in SCLC patients treated with topotecan,” said Dr.
"We and our investigators are very excited about the chemoprotective effects of ALRN-6924 observed in the dose optimization part of our ongoing trial in SCLC patients. Based on the interim data from the first 17 patients and published rates of single-agent topotecan-related toxicities in 2nd line SCLC patients, we now believe even more strongly that ALRN-6924 can selectively induce cell cycle arrest to protect cancer patients from the toxic side effects of chemotherapy. We believe these data represent an important step in our goal to drive a paradigm shift in the management of chemotherapy-induced toxicities, by creating a treatment that turns toxic chemotherapy into a form of well-tolerated, targeted therapy,” said Dr. Manuel Aivado, President and CEO of
The key interim results from the Phase 1b dose optimization part of the trial as of the data cut-off date of
|ALRN-6924 0.3 mg/kg +
Topotecan 1.5 mg/m2
|ALRN-6924 (all doses) +
Topotecan 1.5 mg/m2
*NCI CTC Grade ≥3
|All AEs||5 (83)||16 (94)|
|Neutropenia||4 (67)||15 (88)|
|Leukopenia||2 (33)||9 (53)|
|Thrombocytopenia||2 (33)||6 (35)|
|Anemia||1 (17)||4 (24)|
NCI CTC Grade 4**
|2 (33)||8 (47)|
*Based on lab values (except for fatigue and nausea) and all AEs presented are treatment-emergent
**In the first treatment cycle
The Phase 1b portion of the study is designed to identify a dose and a schedule of ALRN-6924 administration to reduce chemotherapy-induced toxicities such as severe anemia and thrombocytopenia, as well as other toxicities resulting from topotecan. In the ongoing dose optimization part of the study, ALRN-6924 is administered 24 hours before each dose of topotecan, which is administered daily on days 1 through 5 of every 21-day treatment cycle.
Phase 1b/2 Trial - Next Steps
The Company is enrolling patients into the expansion cohort of its 0.3mg/kg dose level and plans to initiate enrollment in the schedule optimization part of the Phase 1b/2 trial in
As previously reported, the Company plans to report the top-line final data for the dose optimization and schedule optimization parts 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 carefully monitoring the effect of the coronavirus pandemic on its clinical trial sites and the healthcare system, which may impact the future timing of the trial and the Company’s planned data announcements.
A conference call to discuss these interim data from the Phase 1b/2 study of ALRN-6924 as a chemoprotection agent has been scheduled for
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 such as the interim results presented 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.