Mesoblast dives on FDA stories

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Tom Richardson

Tom RichardsonMarkets reporter and commentator

Aug 11, 2020 – 1.15pm

About Mesoblast
Mesoblast Limited is an Australian-based regenerative medicine company. It seeks to provide treatments for inflammatory ailments, cardiovascular disease and back pain. The company is led by Silviu Itescu, who founded the company in 2004.

Mesoblast dives on FDA reports

About reports
A report is a document that presents information in an organized format for a specific audience and purpose. Although summaries of reports may be delivered orally, complete reports are almost always in the form of written documents.

Mesoblast shares fell 28 per cent after the US healthcare regulator released two advisory reports on Mesoblast’s application to market a stem cell treatment for children with a specific inflammatory condition.

The FDA’s oncologic drugs advisory committee (ODAC) briefings (serving as guidelines for an August 13 meeting) conclude it’s unclear whether clinical trial results submitted provide evidence of sufficient benefit in the treatment of SR-aGVHD, or steroid-refractory acute Graft Versus Host Disease, in pediatric patients.

Mesoblast dives on FDA reports

The stock fell to $3.50 on Tuesday.

However, the ODAC did acknowledge that Mesoblast’s study reached its primary endpoint of a 28-day overall response rate in patients at 69.1 per cent.

The reports also suggest it’s unclear if the durability of the trial patients’ responses require continued infusions of remestemcel-L, while suggesting the FDA’s advisory committee consider the relevance of two previous trials that failed to meet their primary endpoints.

The August 13 advisory committee is scheduled to include discussion as to whether or not an additional clinical trial in SR-aGVHD patients is required for confirmation of effectiveness of the product. The committee is also scheduled to discuss what trial design would be required to provide evidence of effectiveness.

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Mesoblast, which acquired the remestemcel-L product in 2013 from Osiris Therapeutics, already has it approved for the treatment of SR-a-GVHD in children in Japan.

However, the US FDA noted remestemcel-L is yet to be approved in the US in over 20 years of existence, despite multiple clinical trials for different inflammatory conditions.

Mesoblast is yet to respond to the two FDA documents that broadly cover product characterisation and clinical evidence from the submitted trial.

The company is also conducting a Phase 3 clinical trial into the effectiveness of remestemcel-L in treating ventilator-dependent COVID-19 patients, with moderate to severe acute respiratory distress syndrome. It said it expects an interim analysis review of the safety and efficacy data from 90 COVID-19 patients to be available by early September.

On May 13 it completed a $138 million capital raising at $3.20 per share to help fund its clinical trials.

Tom Richardson reports and comments on investment markets. Connect with Tom on Twitter. Email Tom at [email protected]

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