Cell based medicine providers Mesoblast Ltd (ASX:MSB) announced yesterday that it plans to significantly reduce the size of its Phase 3 trial in its MPC-150-IM medicine, which is predominately used for treating chronic heart failure.
This was confirmed following talks with Mesoblast’s development and commercial partner, Teva Pharmaceutical Industries Ltd, along with the United States Food and Drug Administration (FDA).
The Phase 3 trial of its MPC-150-IM medicine is now adjusted as follows:
-Reduction in the Phase 3 trial size 1,165 to around 600 patients, due to a possible change to the primary endpoint.
-The change to the primary endpoint being a comparison of recurrent Heart Failure related Major Adverse Cardiovascular Events (HF-MACE) between patients treated with MPC-150-IM and controls.
-The considered use of recurrent HF-MACE as a primary endpoint in the Phase 3 trial is based on the previous trials, that a single injection of MPC-150-IM had successfully prevented recurrent HF-MACE.
-Another confirmatory study will occur at the same time, in an identical patient population of around 600 patients, whilst using the same endpoint.
However, with the finalised Phase 2 trials, patients treated with MPC-150-IM had no traces of HF-MACE for over 36 months of follow up. In comparison to 11 HF-MACE events within the control group.
With Patients that have advanced heart failure, in the form of Left Ventricular Systolic Volume of more than 100ml, who are inherently similar to those patients in the Phase 3 trials, 71% of controls had at least one HF-MACE event. In comparison to those zero, to those who received a single injection of MPC-150-IM.
Mesoblast CEO Silviu Itescu commented on the reduction in the trial size: “The reduction in the size of the Phase 3 trial may significantly shorten the time to trial completion.”
Investors have reacted rather negatively to the news, with MSB shares down approximately 2.6%, at the close of trading yesterday. MSB shares haven’t performed well over the last year, losing around 59% of its value.
Author: Simon Herrmann
Jan 12, 2016
Simon is a financial analyst at independent research firm Wise-owl specialised in small-mid cap growth opportunities and ethical investment opportunities. Simon's aim is to disrupt the cliché approach to investment decision making as he believes that socially and environmentally responsible behaviour is a necessity to long-term wealth creation. Simon has a deep fundamental understanding of the global financial landscape and has compiled 300+ research reports, valuations and corporate appraisals. Simon is commonly featured in major media outlets and his research is published weekly in The Australian.