• Alterity Therapeutics gets firm commitments for $4.8 million in capital raise
  • Mesoblast partners with the Blood and Marrow Transplant Clinical Trials Network for pivotal trial
  • Centers for Medicare & Medicaid Services (CMS) in US confirm tpayment rate for Proteomics PromarkerD predictive test

Alterity raises $4.8 million in placement

Biotech focused on developing disease modifying treatments for neurodegenerative diseases Alterity Therapeutics (ASX:ATH) says it has received binding commitments for a $4.8 million capital raise via a two tranche placement to Australian and international institutions and other unrelated sophisticated, professional investors.

CEO David Stamler says the company is grateful for the support from both current and new investors as it continues to advance its clinical development and research programs.

“We are making excellent progress with our two Phase 2 clinical trials in multiple system atrophy with enrolment recently completed in our randomised, double-blind ATH434-201 study,” he said.

ATH expects preliminary data from the open label biomarker trial in the first half of next year in the first cohort of patients.

“We also remain very active within the medical and scientific communities with recent data presentations at the MDS, AAS and Society for Neuroscience meetings,”  Stamler says.

“In addition, we plan to present new animal data at the Parkinson’s Study Group meeting next month.”


Mesoblast partnership for pivotal trial in adults with SR-aGVHD

Mesoblast (ASX:MSB) has announced that the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), has entered into a deal to develop a pivotal trial of its  lead product candidate Ryoncil (remestemcel-L) in treatment of adults with steroid-refractory acute graft versus host disease (SR-aGvHD)

The BMT CTN, includes centres responsible for ~80% of all US allogeneic BMTs and is funded by the United States National Institutes of Health (NIH).

“We are delighted to be partnering with Mesoblast in this pivotal Phase 3 trial of RYONCIL, a potentially life-saving treatment for adolescents and adults with the most severe form of aGVH,” chair-elect of the BMT CTN steering committee and Professor of Internal Medicine and Pediatrics, Icahn School of Medicine at Mount Sinai, New York Dr John Levine, says.

“The clinical data from children treated with RYONCIL which support this trial are very compelling.”

The trial to be developed and executed by the BMT CTN intends to evaluate RYONCIL in patients 12 and older who are refractory to both corticosteroids and a second line agent such as ruxolitinib, for whom there are no approved therapies.

In its September 2023 draft guidance to industry for development of agents to treat aGVHD, the US FDA said a marketing application might be supported by positive results from a single-arm trial in a population with refractory aGVHD where there are no available therapies.

Reimbursement price set for Proteomics PromarkerD test in US

Proteomics International Laboratories (ASX:PIQ)  has announced the Centers for Medicare & Medicaid Services (CMS) have confirmed the payment rate for the PromarkerD predictive test for diabetic kidney disease of US$390.75 in the US.

The CMS is the US federal agency responsible for providing health coverage to more than 100 million Americans through Medicare and Medicaid.

The reimbursement rate set by CMS applies to all patients accessing government-funded healthcare in the country. Medicare covers health care costs for people over the age of 65, while Medicaid covers eligible low-income Americans.

PIQ says the rate, set by the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, follows a period of public comment and will become effective from January 1, 2024.

“As we prepare for the US launch of PromarkerD, the CMS price is an essential component of the roll-out strategy, both because of the number of people it covers, and because many private payers follow CMS pricing,” PIQ managing director Dr Richard Lipscombe says.

The reimbursement price comes after the American Medical Association (AMA) approved a unique CPT Proprietary Laboratory Analyses (PLA) code 0385U for PromarkerD in January.

PIQ says ~32 million adults live with diabetes in the US whilst globally this number totals 537 million adults.