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Moleculin Completes End of Phase 2 Meeting with FDA for Annamycin in AML

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Moleculin Biotech has completed its End of Phase 2 (EOP2) meeting with the FDA for its Phase 1B/2 clinical trial of Annamycin combined with Cytarabine for treating AML (MB-106). The meeting focused on reviewing clinical data and planning the next steps, with official outcomes expected by Q3 2024. Interim results show that out of 22 enrolled subjects, 45% achieved a composite complete remission (CRc) and 40% had a complete remission (CR). For second-line treatments, 50% achieved CR and 60% achieved CRc. Annamycin holds Fast Track Status and Orphan Drug Designations for relapsed or refractory AML in the U.S. and EMA.

Positive
  • Completion of EOP2 meeting with FDA could signal progression to Phase 3.
  • 45% of enrolled subjects achieved CRc and 40% achieved CR.
  • 50% of second-line treatment subjects achieved CR and 60% achieved CRc.
  • Annamycin has Fast Track Status and Orphan Drug Designation from FDA and EMA, indicating regulatory support.
Negative
  • Outcomes of the FDA meeting are pending, creating uncertainty.
  • Only 22 subjects enrolled, which may be considered a small sample size for wider generalization.

The completion of the End of Phase 2 (EOP2) meeting with the FDA signifies a critical milestone for Moleculin's Annamycin in combination with Cytarabine (AnnAraC) for treating acute myeloid leukemia (AML). The drug combination showed promising efficacy in the clinical trial, with a significant 45% of subjects achieving a composite complete remission (CRc). This includes 40% of subjects achieving complete remission and 50% achieving complete remission in the second-line treatment setting alone. These results indicate a potentially effective therapeutic option for AML patients, especially those who have relapsed or are refractory to initial treatments.

In terms of clinical implications, the fact that Annamycin has already been granted Fast Track Status and Orphan Drug Designation by the FDA adds weight to its potential impact. Fast Track Status could expedite the review process, thereby bringing this treatment to patients faster if the results continue to be positive. However, it's critical to await the FDA's formal feedback and any further clinical data before drawing more definitive conclusions. This could influence both clinical practice and future research directions significantly.

From an investment perspective, the successful completion of the EOP2 meeting with the FDA is a positive signal for Moleculin Biotech. The reported efficacy of Annamycin, particularly the 54% CR rate in the 1st or 2nd line treatment, positions the company favorably in the competitive oncology market. The Fast Track Status and Orphan Drug Designation are strategic advantages, potentially accelerating the drug's path to market and thus its revenue generation timeline.

Investors should keep an eye on the upcoming announcement of the FDA's official minutes, which will provide more concrete guidance on the next steps. In the short term, this news may create a positive sentiment around Moleculin's stock, potentially driving up its value. However, long-term gains will depend on subsequent clinical trial results and market adoption of the drug.

This development is notable for its market implications. The AML treatment landscape is highly competitive and characterized by significant unmet needs. Moleculin's Annamycin, showing a 62% CRc rate in first and second-line settings, offers a new angle in treating AML. Fast Track Status can potentially enhance its market entry, giving Moleculin a competitive edge against existing therapies.

However, it's essential to consider the broader market dynamics. The drug's eventual success will depend on its ability to outperform existing treatments in terms of efficacy, safety and cost-effectiveness. Another consideration is the potential for combination therapies becoming standard practice, which could either complement or compete with Moleculin's offering.

Overall, the short-term outlook seems positive with this step forward, but the long-term market positioning will be determined by further clinical outcomes and strategic execution.

HOUSTON, July 10, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the completion of its End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). The Company expects to report outcomes from the EOP2 meeting upon receipt of official minutes from FDA which is expected by the end of Q3 2024.

"The Moleculin team, along with our regulatory advisors and key opinion leaders, discussed with FDA the MB-106 safety and efficacy clinical findings and proposed next steps for our AML clinical development program," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. "We are grateful to the FDA for what we consider to be a very productive meeting and look forward to reporting its outcome before the end of August."

The EOP2 meeting was supported by second-line treatment results from the Company's ongoing MB-106 clinical trial. As recently reported on June 14, 2024, a total of 22 subjects have been enrolled (the Intent-to-Treat population, ITT), 20 (Lines 1st-7th) of whom have completed efficacy evaluations with 9 subjects (45%) achieving a composite complete remission (CRc or CR/CRi), consisting of 8 (40%) subjects with complete remission (CR) and one subject with complete remission with an incomplete recovery of peripheral blood counts (CRi), following treatment with AnnAraC. Efficacy outcomes for 2 additional subjects (enrolled and treated) are pending.

Of the 10 ITT subjects for whom AnnAraC was administered in the 2nd line setting, 5 achieved a CR (50%) and 6 achieved a CRc (60%). Of the 13 subjects in the ITT evaluable population that were 1st or 2nd line treatment, 7 achieved a CR (54%) and 8 achieved a CRc (62%). The mDOR for the 9 subjects who achieved a CRc is approximately 7 months and climbing.

Annamycin currently has Fast Track Status and Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency (EMA). For more information about the ongoing MB-106 Phase 1B/2 trial, visit clinicaltrialsregister.eu and reference EudraCT 2020-005493-10 or clinicaltrials.gov and reference NCT05319587.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. All interim and preliminary data related to its active clinical trials are subject to change.

Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of viruses, as well as certain cancer indications.

For more information about the Company, please visit www.moleculin.com and connect on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission (SEC) and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com

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SOURCE Moleculin Biotech, Inc.

FAQ

What was the recent FDA EOP2 meeting about for MBRX?

The EOP2 meeting with the FDA reviewed clinical data from Moleculin's Phase 1B/2 trial of Annamycin combined with Cytarabine for AML and discussed next steps.

What are the interim results of the MB-106 trial for MBRX?

Interim results show that 45% of enrolled subjects achieved a composite complete remission (CRc) and 40% reached complete remission (CR).

What is the significance of Annamycin's Fast Track Status for MBRX?

Fast Track Status from the FDA facilitates the development and expedites the review process for drugs treating serious conditions like AML.

How many subjects achieved complete remission in the MB-106 trial for MBRX?

In the MB-106 trial, 40% of enrolled subjects achieved complete remission (CR).

When can we expect the official outcome of MBRX's EOP2 meeting with the FDA?

The official outcome of the EOP2 meeting is expected by the end of Q3 2024.

Moleculin Biotech, Inc.

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