Bioxyne's COPD clinical trial disappoints

Bioxyne (ASX:BXN) has provided mixed preliminary results from a trial of immunotherapeutic HI 164 OV in COPD, revealing that the drug provided no benefit across the study group as a whole.

The Phase IIb trial in 320 patients with COPD (chronic obstructive pulmonary disease) showed no statistically significant clinical benefit in reducing exacerbations or hospitalisations across the entire cohort of patients.

But significant clinical benefits were found in the 30% of patients under the age of 65. Among this group, hospitalisations associated with exacerbations were reduced 50%, and average hospital stay required fell 65%.

Time to first exacerbation was increased and the number of corticosteroid treatments required was reduced.

Announcing the findings from the preliminary analysis of the results, Bioxyne said it will need to investigate why the treatment appears to be less effective in older patients.

But it added that the under 65 age group accounts for around 27% of COPD sufferers, which “still represents an attractive market opportunity.”

Bioxyne (ASX:BXN) shares crashed 81.6% in Thursday's trading after the results were announced, falling below the $0.190 debut trading price for the first time since late-April.

Bioxyne is currently in talks with several potential licensees for the treatment. The company will now conduct a targeted marketing campaign in conjunction with advisory firm Torreya Partners, approaching additional possible partners.

Some companies involved in the preliminary discussions have expressed an interest in licensing the product as an immunotherapeutic for indications other than COPD.

COPD is characterised by chronic bronchitis or emphysema, leading to limited airflow to the lungs. It has been estimated to be the sixth leading cause of death worldwide, and the fourth leading cause in the US.

HI 164 OV is an oral vaccine designed to control bacterial infections of airways damaged by toxins. It is created from haemophilus influenza bacteria.

Bioxyne was created in April through the merger of Hunter Immunology and Probiomics, and the company's relisting on the ASX. The reverse takeover deal was first signed in December 2011.

Bioxyne (ASX:BXN) shares were trading at $0.048 as of 11.30am Friday.