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Aradigm's inhaled antibiotic fails late-stage study, shares sink
December 1, 2016 / 12:50 PM / in a year

Aradigm's inhaled antibiotic fails late-stage study, shares sink

(Reuters) - Aradigm Corp said on Thursday its inhaled antibiotic for a rare, incurable disorder affecting the lungs failed in a late-stage study, sending the company’s shares down nearly 54 percent in premarket trading.

The once-a-day formulation, Pulmaquin, is being tested in patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic lung infections with the bacteria P. aeruginosa, which leads to the enlargement of the lungs’ airways.

The main goal of two late-stage trials was to show an increase in the median time taken till the first instance of a pulmonary exacerbation (PE).

In one trial, called ORBIT-3, Pulmaquin outperformed a placebo, but the results were not considered statistically significant, the company said.

Patients given Pulmaquin recorded a median time of 221 days till the first pulmonary exacerbation, while patients given a placebo took 136 days.

However in a second trial, ORBIT-4, Pulmaquin was deemed to have had a statistically significant benefit over placebo.

In this trial, patients given Pulmaquin recorded a median time of 230 days till the first pulmonary exacerbation, while patients given a placebo took 163 days.

There were eight deaths in the ORBIT-3 trial and six in the ORBIT-4 trial, but none of the deaths were related to Pulmaquin, Aradigm said.

Non-CF BE is a severe, chronic disease associated with high rates of mortality and has no approved treatment so far. It affects 150,000 people in the United States and more than 200,000 in Europe.

The U.S. Food and Drug Administration has given Pulmaquin an “orphan drug” and a “fast track” status, and has deemed the drug as a qualified infectious disease product.

Pulmaquin contains a widely prescribed broad-spectrum antibiotic called ciprofloxacin, which exists in oral and intravenous formulations to treat acute lung infections.

Aradigm’s inhaled ciprofloxacin formulations, including Pulmaquin, are being evaluated to treat a plethora of respiratory diseases, including cystic fibrosis and non-tuberculous mycobacteria.

They are also being tested to prevent and treat bioterrorism infections such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and anthrax.

The Hayward, California-based Aradigm is also developing an inhaled treatment to deter smoking.

The company’s shares were down nearly 54 percent at $2.43 in premarket trading.

(This story corrects to add dropped word “shares” in first paragraph)

Reporting by Divya Grover; Editing by Saumyadeb Chakrabarty and Savio D'Souza

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