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Company Highlights
- Asthma patients breathing easier
- Results announced for second Phase 3 trial of Bronchitol in people with CF
- PXS25 passes its first clinical hurdle
- New facility fully operational
Asthma patients breathing easier
Asthma patients' breathing was improved by an outstanding 32-49% in Phase 2 clinical trials of Pharmaxis' new anti-inflammatory agent ASM8.
The new molecule was obtained by Pharmaxis in its recent acquisition of the Canadian company Topigen Pharmaceuticals.
Tested on patients with allergic asthma, the Phase 2a dosage study found inhalation of 8mg of ASM8 reduced bronchoconstriction by 32% during the early phase of an allergen challenge, and by 49% during the late phase of the response compared to control. Inflammation of the lungs was also reduced by 49% 7 hours later, and by 57% 24 hours after the allergen challenge.
The results indicate ASM8 could be a potent new therapy in treating severe asthma, which is significantly undertreated by current medicines and currently affects more than three million people in the U.S., Europe and Japan.
As a once-a-day inhaled medicine with a strong safety profile, ASM8 is already showing clear advantages over many of its in-market competitors, which require injections, intravenous transfusion, are expensive or have significant side-effects.
A second Phase II trial of longer duration will begin recruiting later this year.
Results announced for second Phase 3 trial of Bronchitol in people living with CF
Pharmaxis is pleased to announce top line results from the second large-scale global Phase III trial (CF302) of Bronchitol® (mannitol inhalation powder) in patients with cystic fibrosis (CF).
The results support the early and sustained improvement in lung function in cystic fibrosis patients seen in the first phase III study (CF301) and Pharmaxis will now move forward to meet the U.S. Food & Drug Administration (FDA) later this year to discuss a New Drug Application (NDA) for Bronchitol.
Patients treated with Bronchitol had an 8.2 % (107mL) improvement in lung function (FEV1) compared to baseline over the 26 weeks of the study which was highly significant (p<0.001) and similar to the 6.3% improvement seen in the earlier study (CF301). Significant improvements from baseline were seen on Bronchitol at 6, 14 and 26 weeks of treatment (p≤0.001).
The primary endpoint comparing the FEV1 mL improvement of Bronchitol to control over the 26 weeks, narrowly missed statistical significance (p=0.059). This was despite the overall treatment effect across 26 weeks expressed as a percentage being similar to that reported in CF301. In fact, the FEV1 percentage improvement of Bronchitol compared to control in CF302 over the 26 weeks was significant (p=0.029). Secondary endpoints targeting other measures of lung function also showed significanta improvement in patients on Bronchitol compared with control, including forced vital capacity (FVC) (p=0.022), and FEV1 % predicted (p=0.024).
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PXS25 passes its first clinical hurdle
The first Phase 1 trial of Pharmaxis' new antifibrotic agent PXS25 has delivered encouraging results.
Designed to determine the tolerance and pharmaceutical properties of PXS25 following intravenous administration, the trial found the drug to be safe, well tolerated and with an excellent pharmacokinetic profile in healthy volunteers.
PXS25 is being developed as a potential new treatment for pulmonary fibrosis, which affects over 500,000 people in the major pharmaceutical markets.
Additional Phase 1 trials will be completed before PXS25 is evaluated in patients with lung disease.
New facility fully operational
The new manufacturing plant in Rodborough Road, Frenchs Forest is now fully operational and the qualification work on the new equipment is essentially complete. The spray drier operates well and has produced a number of batches of both Bronchitol and Aridol within our specification. Further fine tuning is being concluded before the validation process commences and ahead of an inspection by the relevant regulatory
authority.
The spray drier has capacity to produce enough Bronchitol to treat 40,000 patients a year.