Things are well and truly on track for clinical stage pharmaceutical company Pharmaxis (ASX: PXS), a sentiment confirmed by CEO Gary Phillips in his shareholder address in their recent quarterly results. The Company has made significant progress in three clinical trial programs, with plenty on the horizon for their preclinical pipeline too. 

Lead asset PXS-5505 is now in FDA approved Phase 2 trials for the treatment of myelofibrosis. Despite the COVID pandemic pulling hospital resources away from research to acute care of COVID patients, Pharmaxis has maintained momentum to see increased recruitment in Australian and South Korean centres. The Company also added extra sites in Taiwan and the USA to ensure little to no interruption to the study’s flow.

Following preclinical work done by The University of Rochester in New York, PXS-5505 has also been approved by the FDA under the Investigational New Drug scheme to commence a Phase 2 study looking into liver cancer. 

After a successful (and oversubscribed) capital raise which saw increased support from major biotech investors as well as their retail base, Pharmaxis is planning to begin the Phase 2 study into liver cancer in collaboration with The University of Rochester. The funds from the capital raise have been instrumental in facilitating the swift initiation of these trials. 

And last but certainly not least, PXS-6302, Pharmaxis’ anti-skin scarring hopeful is moving through to Phase 1c trials in patients with established scars. The study will be led by none other than Professor Fiona Wood AM and her colleagues at The University of Western Australia. Another trial in burn scars will begin later this year to assess the drug’s performance in the prevention of problematic scars post surgery and treatment. 

The Company’s clinical pipeline and research is in part supported by their already approved on market products Bronchitol and Aridol. Bronchitol is an inhaled dry powder version of mannitol and is used for the treatment of cystic fibrosis. Aridol is a lung function test that is approved for use in multiple major markets. 

Like many companies, COVID has had an impact on Pharmaxis. In particular is the US launch of Bronchitol where patients are not able to visit hospitals to be prescribed new drugs. Other markets have seen a drop in sales with the Company noting that this is likely due to a reduction in patient compliance with medication arising from less regular visits to clinics during this time. Underlying market trends aside, the Company is confident that sales will bounce back as the Omicron variant slows and vaccination rates increase.  

Pharmaxis reported a cash runway of just over 5 quarters with over $20 million in the bank. Government grants and tax incentives for ongoing clinical work also provide extra funding for Pharmaxis projects. 

Results from the PXS-5505 trial in myelofibrosis are due at the end of the year whilst PXS-6302 study results are expected in Q4. 

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