Moderna and Myrtelle among those picked for FDA rare disease programme

2024-06-06
Pharmaceutical Technology
基因疗法临床研究
Moderna and Myrtelle among those picked for FDA rare disease programme
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来源: Pharmaceutical Technology
The FDA’s pilot programme is set to accelerate the development of novel drug and biological products for rare diseases. Credit: Tada Images via Shutterstock.
Moderna and Myrtelle’s rare programmes will both be included in a pilot programme by the US Food and Drug Administration (FDA) that aims to accelerate the development of novel drugs and biological products for rare diseases.
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Free ReportHow is the Biopharmaceutical industry evolving?
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Moderna and Myrtelle among those picked for FDA rare disease programme
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Moderna and Myrtelle among those picked for FDA rare disease programme
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Moderna and Myrtelle among those picked for FDA rare disease programme
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Announced in September 2023, the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) programme aims to expedite new drug development by providing sponsors with frequent advice and regular communication with the FDA to advance their programme as quickly as possible.
Moderna’s START programme evaluates mRNA-3705, an investigational therapeutic for methylmalonic acidemia (MMA) due to methylmalonic-CoA mutase (MUT) deficiency. The candidate is being investigated in a Phase I/II Landmark study (NCT04899310), designed to evaluate the safety and tolerability of Mrna-3705 administered via intravenous infusion (IV) in patients one year and older with isolated MMA due to methylmalonyl-CoA mutase (hMUT) deficiency.
Myrtelle is developing rAAV-Olig001 for Canavan disease (CD), a fatal childhood genetic disorder characterised by the collapse of white matter in the brain due to a mutation in the aspartoacylase gene (ASPA). This affects the creation of myelin, leading to a deficiency in the aspartoacylase enzyme.
The gene therapy is a new vector from a class of recombinant adeno-associated viruses (rAAVs) that selectively target oligodendrocytes, the cells in the brain that produce myelin.
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Moderna and Myrtelle among those picked for FDA rare disease programme
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Moderna and Myrtelle among those picked for FDA rare disease programme
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来源: Pharmaceutical Technology
It is being evaluated in a Phase l/ll clinical trial (NCT04833907) enrolling 24 patients with CD. It involves administering the gene therapy to patients using neurosurgical procedures, which involves direct administration of gene therapy to affected regions of the brain. Outcome measures for the open-label clinical trial include longitudinal clinical assessments and brain imaging.
In the announcement accompanying the acceptance, Myrtelle global regulatory affairs senior vice president Nancy Barone Kribbssaid: “Opening the lines of communications beyond traditional meeting pathways provides the opportunity to quickly address development issues that would otherwise delay progression to market application.”
Applicants had to meet certain criteria from the Center for Biologics Evaluation and Research (CBER), which has selected four participants for the pilot programme;, and the Center for Drug Evaluation and Research (CDER), which has selected three.
Earlier this week, Denali Therapeutics, Neurogene, Larimar Therapeutics and Grace Science all announced that programmes will be included in the pilot. Neurogene’s gene therapy NGN-401 is currently under investigation to treat Rett syndrome.
Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape.
GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Access the report to:
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector.
Download the full report to understand what to expect and how to align your strategies for success.
Thank you.You will receive an email shortly. Please check your inbox to download the Report.
By GlobalData
Moderna and Myrtelle among those picked for FDA rare disease programme
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来源: Pharmaceutical Technology
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