HOUSTON - Moleculin Biotech, Inc., (NASDAQ:MBRX), a clinical-stage pharmaceutical company, reported positive interim results from its ongoing acute myeloid leukemia (AML) clinical development program. The company announced that the combination of Annamycin and Cytarabine, referred to as AnnAraC, achieved a composite complete remission (CRc) rate of 62% in first and second-line AML subjects.
The full MB-106 trial, which includes patients who have undergone up to seven lines of prior therapy, showed a CRc rate of 45% with median durability of remission at 4.9 months. These findings support the advancement to a Phase 2 registration-directed clinical trial (MB-108) to gather further efficacy data for a potential New Drug Approval (NDA) application.
Moleculin's Chairman and CEO, Walter Klemp, noted the improvement in CRc rates from 37% to 45% for the 20 subjects in the MB-106 trial, emphasizing the potential of AnnAraC to offer a viable alternative for second-line patients. Klemp stated the company is preparing for an End of Phase 2 meeting with the FDA and anticipates commencing a pivotal registration study as a second-line therapy in AML early next year.
The MB-106 trial, which is being conducted across nine clinical sites in Poland and Italy, has enrolled 20 subjects to date. The study protocol was expanded to include first line subjects to enable the design of a potential confirmatory Phase 3 post-approval study. Moleculin aims to secure an accelerated approval pathway for AnnAraC as a second-line therapy and is continuing to recruit first-line subjects for additional data.
The trial has already recruited the desired number of second-line subjects to support an End of Phase 2 meeting with the FDA. The median age of subjects is 69, with ages ranging from 19 to 78. The company may complete the trial with fewer than the 28 subjects initially planned.
Moleculin's planned pathway for Annamycin in combination with Cytarabine for the treatment of AML focuses on securing initial NDA approval as a second line therapy. The company highlighted the significance of the results in second-line subjects, as it believes this data is the most important from the trial.
The virtual AML Clinical Day, featuring Dr. Martin Tallman, will discuss these results and the ongoing clinical trials. Moleculin's broad portfolio targets hard-to-treat tumors and viruses, with Annamycin being its lead program.
This information is based on a press release statement from Moleculin Biotech, Inc.
InvestingPro Insights
Amid the promising clinical developments reported by Moleculin Biotech, Inc. (NASDAQ:MBRX), investors may find it insightful to consider the company's financial health and market performance. According to InvestingPro, Moleculin holds more cash than debt on its balance sheet, which can be a positive sign of financial stability. However, the company is quickly burning through cash, which is a factor to watch closely as it progresses through expensive clinical trials.
InvestingPro data shows that Moleculin has a market capitalization of 11.23 million USD, reflecting the market's current valuation of the company. With an adjusted P/E ratio over the last twelve months as of Q4 2023 standing at -0.38, it indicates that the company is not currently profitable. This aligns with an InvestingPro Tip that analysts do not anticipate the company will be profitable this year. Additionally, MBRX's stock price has experienced significant volatility, with a 1-year price total return of -57.99%, which investors should consider in the context of the company's clinical trial results and future prospects.
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