On June 5, 2019, Aileron Therapeutics, Inc. (the “Company”) announced updated information regarding the design and anticipated timing of data
from its ongoing and planned clinical trials of ALRN-6924.
Combination with Palbociclib (Ibrance) in MDM2-Amplified Advanced Solid Tumors
The Company is conducting a Phase 2a clinical trial of the combination of ALRN-6924 and palbociclib (Ibrance), marketed by Pfizer, Inc., for the treatment of
MDM2-amplified advanced solid tumors. The Company plans to enroll up to 25 patients in this trial. The objectives of this trial include evaluation of the safety, tolerability and activity of the combination, including determination of the overall
response rate and other measures of activity including progression-free survival and overall survival. The Company plans to use the data from the trial to identify an indication to investigate in further trials of the combination.
The Company plans to disclose interim data from 15 patients enrolled in this trial at the European Society for Medical Oncology Congress 2019, which is
scheduled from September 27 through October 1, 2019, and to have final data from all 25 patients in this trial in the second quarter of 2020.
Myelopreservation Trial in Combination with Topotecan
In
September 2019, the Company plans to begin enrolling patients with advanced small cell lung cancer who are treated with topotecan in a Phase 1b/2 trial of ALRN-6924 to assess ALRN-6924 as a myelopreservative agent protecting against
chemotherapy-induced bone marrow toxicity. The Company plans to enroll up to 40 patients in the Phase 1b portion of the trial and, subject to funding, up to 60 patients in the Phase 2 portion of the trial.
In the trial, patients will receive administration of ALRN-6924 on days
0-4
and administration of topotecan on days
1-5
of every
21-day
treatment cycle. The objectives of the trial include evaluation of the safety and efficacy of ALRN-6924 as a myelopreservative agent, including determining
whether patients experience a reduction of grade 3 or greater neutropenia, anemia and thrombocytopenia and reduction of febrile neutropenia.
The Company
plans to disclose data from the Phase 1b portion of the trial in the second quarter of 2020.
Forward-Looking Statements
Any statements in this Form
8-K
about Aileron’s future expectations, plans and prospects, including statements
about the Company’s future operations, and clinical trials and other statements containing the words “believes,” “anticipates,” “estimates,” “expects,” “intends,” “plans,”
“predicts,” “projects,” “targets,” “may,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. 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 studies and clinical trials will be indicative of results obtained in
future clinical trials; 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; and other factors discussed in the “Risk Factors” section of Aileron’s quarterly report on Form
10-Q
for the period ended March 31, 2019, filed on
May 8, 2019, 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.