- Mesoblast disclosed that the Phase 3 clinical trial of Remestemcel-L is anticipated to complete recruitment in September 2020 in the US.
- At the end of the quarter ended June 2020, Mesoblast had nearly US$129.3 million cash on hand.
- Dimerix reported positive top-line findings in Phase 2a clinical trial of DMX-200 for FSGS.
- The promising data from Phase 2a clinical study bolsters further development of DMX-200 in FSGS.
Compared to the benchmark index, S&P/ASX 200, which ended 0.74% higher, the S&P/ASX 200 Health Care Sector fared better settling 1.43% higher at 41,202.3 on 30 July 2020.
Two ASX-listed healthcare shares contributed to this rise of the sector index and were in the spotlight following critical announcements.
Allogeneic medicines developer Mesoblast Limited (ASX:MSB) provided an update on its quarterly activity and the upcoming milestones of its lead compound remestemcel-L. Another clinical-stage biopharmaceutical company Dimerix Limited (ASX:DXB), on 29 July 2020, reported positive top-line findings in FSGS Phase 2a clinical trial of DMX-200.
Let us delve deep and discuss the recent announcement of MSB & DXB:
Mesoblast Updated on Upcoming Milestones for Remestemcel-L
World-leader in developing allogeneic medicines, Mesoblast Limited has leveraged its mesenchymal lineage cell therapy technology platform for forming a comprehensive commercial products portfolio. The Company has a robust & vast global IP portfolio with protection expanding through to 2040 in all key markets.
On 30 July 2020, Mesoblast provided an update on forthcoming milestones for its lead drug candidate remestemcel-L, including an activity report for Q4 (ended 30 June 2020).
Mesoblast updates on Phase 3 clinical trial of Remestemcel-L for COVID-19 induced ARDS (Acute Respiratory Distress Syndrome).
The independent DSMB (Data Safety Monitoring Board) has set a date for early September to complete the first interim evaluation of Phase 3 clinical trial of remestemcel-L in ventilator-dependent patients having COVID-19 with moderate to severe symptoms of ARDS.
The first 90 patients of the trial will have completed 30 days of follow up during August. Subsequently, the DSMB will perform an interim analysis review of the safety and efficacy data. The board will then inform Mesoblast on whether the trial should continue as planned or should stop early.
Moreover, the Company disclosed that up to thirty leading medical centres across the US are projected to participate in the trial, which will complete recruitment by September 2020.
Mesoblast also provided an update on the use of Remestemcel-L for Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
The Company mentioned that US FDA’s ODAC (Oncologic Drugs Advisory Committee) had scheduled a meeting on 13 August 2020 to review data supporting MSB’s Biologics License Application for approval of RYONCIL™ in the treatment of SR-aGVHD in children.
Notably, RYONCIL™ has been accepted for priority review by the US FDA with an action date of 30 September 2020, under the PDUFA. If approved, RYONCIL™ will be launched the US in 2020 with the product inventory ready.
Cash Flow Report for Q4 FY20
The Company has approximately US$129.3 million cash on hand at the end of the quarter. In May 2020, Mesoblast completed capital raise of US$90 million from global institutional investors.
- Total operating activities resulted in net cash used in June quarter was nearly US$19.6 million, as Mesoblast continues to prepare for the potential approval and commercial launch of RYONCIL™ in the US.
- R&D payments stood at ~US$6.7 million, primarily for Phase 3 clinical trial programs.
Stock Performance: On 30 July 2020, MSB last quoted at A$3.830, up by 4.932% with a market capitalisation of nearly A$2.13 billion. MSB shares have generated returns of 15.51% and 21.67% return in the last three months and six months, respectively.
Dimerix Reported Positive Top-Line Results in FSGS Phase 2a Clinical Trial
Clinical-stage biopharmaceutical Company Dimerix Limited is engaged in developing innovative new therapies for diseases having unmet medical needs. Currently, the Company is developing its proprietary product DMX-200 for Focal Segmental Glomerulosclerosis (FSGS), Diabetic Kidney Disease, as well as for Acute Respiratory Distress Syndrome (ARDS).
On 29 July 2020, Dimerix disclosed positive top-line findings from the Phase 2a ACTION study of DMX-200 for treating FSGS, which is a rare kidney disorder with no approved treatment.
The Phase 2a clinical trial was a randomised, placebo-controlled, double-blind, crossover study planned to assess the safety as well as preliminary indications of efficacy of DMX-200 in FSGS patients. In the study patients having FSGS were administered with 240 mg of oral DMX-200 already taking a stable 300 mg dose of irbesartan (the angiotensin receptor blocker).
Positive Top-Line findings in FSGS Phase 2a Clinical Trial -
DMX-200 was found to be safe and well-tolerated in FSGS patients. Nearly 86% of patients demonstrated a reduction in proteinuria with DMX-200 Vs placebo. The Phase 2a clinical study delivered promising data bolstering further development of DMX-200 in FSGS.
Stock Performance: On 30 July 2020, DXB stock last quoted at A$0.470, up by 3.297% from its previous close. The Company has a market capitalisation of A$89.98 million with ~197.75 million outstanding shares. DXB shares have generated outstanding returns of 133.33% and 225.00% in the last three months and six months, respectively.