Mesoblast Limited (MSB.AX, MBLTY.PK) reported that its loss after tax for fiscal year 2015 widened to A$119.4 million from A$81.0 million for the prior period. The wider loss was a result of expenses from continuing operations increasing by A$43.8 million from $118.1 million to A$161.9 million.
Of the A$43.8 million increase, expenses from continuing operations have increased by $33.2m (28%) in constant currency as we continue to invest in late-stage pipeline. The remaining A$10.6 million increase results from the depreciating AUD:USD exchange rate.
Chief Executive Silviu Itescu said, "We have made strong progress during the past year in moving forward our Phase 3, Tier 1 clinical programs, and have appropriately focused our resources on their execution."
"We are particularly pleased with the outcome of the recent meeting between our development and commercialization partner Teva Pharmaceutical Industries Ltd (TEVA) and the United States Food and Drug Administration (FDA) regarding our Phase 3 chronic heart failure program. The ongoing Phase 3 trial continues to recruit well and, as a result of the FDA meeting, has the potential for early completion based on overwhelming efficacy."
Following the meeting between Teva and the FDA, important changes to the Phase 3 chronic heart failure program for MPC-150-IM have been agreed.
There will be a reduction in the total number of subjects to be recruited for the ongoing Phase 3 trial, using a time to first event analysis of heart failure-related major adverse cardiovascular events (HF-MACE) as the primary endpoint, from approximately 1,730 to 1,165.
An interim analysis will be performed in the ongoing Phase 3 trial when 50% of the HF-MACE have occurred, which will include a test for superiority allowing for the possibility of stopping of the trial early based on overwhelming efficacy.
A second, confirmatory study is planned to be conducted in parallel in an identical patient population of approximately 500 subjects using recurrent HF-MACE as the primary endpoint.
The use of recurrent HF-MACE as a primary endpoint in the confirmatory study is supported by a new analysis of the completed Phase 2 trial, where patients treated with MPC-150-IM had no HF-MACE over 36 months of follow-up, compared with 11 recurrent HF-MACE in the control group (p less than 0.001, log rank test).
The company noted that the Phase 3 program in Chronic Discogenic Low Back Pain or CDLBP is recruiting well across North American sites. It has received positive feedback from discussions with the European Medicines Agency and expect to expand the program to European sites.
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