Lower extremity arterial disease in patients with diabetes: a contemporary narrative review



biotech companies with phase 3 trials 2021 :: Article Creator

Moleculin Biotech Receives Positive FDA Guidance For Acceleration Of AML Trial

Moleculin Biotech (MBRX) has received FDA feedback and guidance on its IND amendment that has allowed a reduction in the size of its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine for the treatment of Acute Myeloid Leukemia, or AML, patients who are refractory to or relapsed after induction therapy. The company expects to reach the first unblinding in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due to the positive response the company received in meetings during December with potential investigators regarding recruitment for the trial. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma.

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    • Positive Phase 3 Results For Zealand Pharma's Glepaglutide

    Biotech company Zealand Pharma A/S, an innovator in peptide-based medicines, announced the positive topline results from its phase 3 trial of glepaglutide on Friday.

    A total of 106 patients with short-bowel syndrome (SBS) who also experienced intestinal failure and dependency on parenteral support (PS) at least three days per week took part in the evenly randomized double-blind trial, receiving treatment with 10mg glepaglutide either once or twice weekly, or a placebo.

    It was found that glepaglutide, a long-acting GLP-2 analogue, when given twice weekly as subcutaneous delivery via auto-injector in SBS patients met the primary endpoint in the EASE 1 phase 3 trial.

    The study found that total weekly volume of perenteral support at 24 weeks was statistically significantly reduced compared to placebo (p=0.0039). In the twice weekly group, 66% of patients had a clinically meaningful response.

    Once weekly delivery treatment with glepaglutide also resulted in a numeric reduction of weekly parenteral support, but was not of statistical significance, and a total of nine participants treated with glepaglutide were weaned of parenteral support and achieved enteral autonomy.

    At the end of the 24 weeks, average reduction in parenteral support from baseline was 5.13 litres/week in twice-weekly glepaglutide dosed patients and 3.13 litres/week in those dosed once per week. Placebo treatment resulted in a reduction in parenteral support of 2.85 litres/week.

    Glepaglutide was found to be apparently safe and well-tolerated in the EASE 1 trial, the most frequently reported adverse events being injection site reactions and gastrointestinal events.

    Dr David Kendall, chief medical officer of Zealand Pharma, said: "We are extremely pleased with the results of the phase 3 EASE 1 trial […] We are particularly encouraged that a number of patients treated with glepaglutide were able to significantly reduce the burden of parenteral support."

    "We look forward to seeing the results of the ongoing EASE 2 and 3 long term extension trials and engaging with the regulatory authorities as we plan for submission of our NDA," he continued.

    An EASE 4 phase 3b trial is also planned to assess long-term effects of glepaglutide on intestinal fluid and energy uptake.

    Dr Adam Steensberg, chief executive officer of Zealand Pharma, said: "We are enormously privileged to have such a rich pipeline of proprietary peptides that in the last six months have reported two positive phase 3 trials for two separate programs aimed at changing the lives of patients living with rare and severe diseases."

    SBS, a complex chronic and severe condition associated with reduced or complete loss of intenstinal function, often results in patients having to be connected to infusion lines and pumps every day. They are also at risk of serious and life-threatening complications, such as sepsis, blood clots, liver damage, and renal impairment.





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