Pharmaxis Ltd (ASX:PXS, OTC:PMXSF) — soon to be renamed Syntara — has announced a major company restructure to refocus on developing drugs to treat blood-related cancers. The restructure involves the creation of clinical stage drug development company, Syntara and the sale of its mannitol respiratory business unit, along with changes to the company’s board of directors.
The move, which will see the company primarily focus on clinical development, will result in a significant reduction in annual costs — core expenses are expected to drop by more than 60%, saving the company more than $14 million per year.
The company has five planned clinical studies to deliver results in high unmet need diseases by mid-2025.
Pharmaxis CEO Gary Phillips said: “Over the last few years Pharmaxis has built a commanding position in lysyl oxidase biology and chemistry research. We have collaborated with leading clinicians and scientists worldwide and forged through the early stage studies that have given us a clinical pipeline with great potential and resulted in multiple Nature publications.
“Building on this heritage and the proven capability of our discovery and development teams, the restructure announced today and the creation of Syntara enables us to focus and accelerate our clinical development programs.
“In PXS‐5505 we have a best‐in‐class drug with an excellent safety profile that has the potential to offer disease modifying effect to patients with haematological malignancies. Syntara and its shareholders are in the unique position of having five planned clinical programs that can deliver company transforming results within a two-year period and I am very excited to start on this new journey.
“Arna Pharma is ideally placed to continue on the ground‐breaking work Pharmaxis has done in getting two drugs through global regulatory approvals and marketed to patients worldwide, including adults and children living with cystic fibrosis. I am delighted that Bronchitol and Aridol will continue to be supplied without interruption.”
Sale of mannitol business unit
A contract to sell the mannitol respiratory business unit to Arna Pharma Pty Ltd was signed yesterday. The sale is set to be finalised by the end of the month when Arna Pharma will take over the unit’s day to day operations and commence an eight month process of transferring production of Aridol and Bronchitol at its multi‐product Sydney facility.
Arna Pharma will reimburse Pharmaxis for the majority of the expenses Pharmaxis will incur through to May 2024, and Pharmaxis will receive ongoing royalties for eight years from Arna Pharma’s Sydney based business including Bronchitol and Aridol.
Syntara: clinical stage drug development
Clinical‐stage drug development company “Syntara” will be primarily focused on blood related cancers.
Lead drug candidate, PXS‐5505
Lead drug candidate, PXS‐5505, is a best‐in‐class inhibitor of lysyl oxidase that has already reported positive Phase 2 data in myelofibrosis patients. This program is expected to issue a further update at the American Society of Hematology conference in December 2023.
The next phase of clinical development for PXS‐5505 will be the commencement of an FDA agreed study design, using PXS‐5505 in combination with a JAK inhibitor — the standard of care. This program is expected to recruit its first patient in Q4 2023 and to report interim data by the end of next year.
Other programs
While the majority of resources will be focused on PXS‐5505, Syntara will also be advancing both oral and topical pan‐LOX inhibitors in Phase 2 scar prevention and scar modification programs. This is part of an ongoing collaboration with Professor Fiona Wood and the University of Western Australia that has reported positive results in May.
The company will also continue a trial with PXS‐4728, a novel anti‐inflammatory drug candidate for the treatment of early stage neurodegenerative diseases which is being substantially funded by Parkinson’s UK.
The company will also explore the use of PXS‐5505 in another haematological malignancy, myelodysplastic syndrome, following breakthrough preclinical data published in Nature Communications earlier this year.
Board changes
As part of the restructure, the company’s board size has been reduced. Malcolm McComas retires after serving for 11 years as chair, to be replaced by current director Dr Kathleen Metters, effective today.
Dr Neil Graham also retires today after three years as a non‐executive director, while current non‐executive directors, Dr Simon Green and Hashan De Silva, will continue together with chief executive officer and managing director Gary Phillips.
The company intends to hold further investor events later this year on its clinical pipeline and its future plans.