In The Spotlight: Aradigm Corp

(RTTNews) - Shares of Aradigm Corp. (ARDM) have returned nearly 96% over the past one month as the Company gears up for the big event on January 11, 2018, when a panel of outside experts convened by the FDA will meet.

The FDA panel will review the Company's New Drug Application for Linhaliq (formerly known as Pulmaquin), proposed for the treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa.

Before we delve deeper, let's take a look at non-cystic fibrosis bronchiectasis (NCFBE).

NCFBE is a severe, chronic and rare disease characterized by abnormal dilatation of the bronchi and bronchioles, frequently associated with chronic lung infections. It is often a consequence of a vicious cycle of inflammation, recurrent lung infections, and bronchial wall damage.

This disease affects more than 150,000 people in the U.S. and over 200,000 people in Europe. NCFBE patients who have chronic infections with Pseudomonas aeruginosa have a 6.5-fold increase in hospitalization, three times higher mortality, and a worse quality of life compared with those without P. aeruginosa infections, according to the Company.

There is currently no drug approved for the treatment of NCFBE. The market for this indication is estimated to reach about $1 billion in the U.S and EU by 2022.

The Company submitted the Linhaliq NDA to the FDA based on two phase III pivotal trials (ORBIT-3, ORBIT-4) and phase 2b study (ORBIT-2), among other things.

The primary endpoint in both ORBIT-3 and ORBIT-4 was an increase in the median time to first mild, moderate or severe pulmonary exacerbation ("PE"). The key secondary efficacy endpoint in both trials was the frequency of PE's over the 48-week double-blind treatment period.

In ORBIT-4 the median time to first mild, moderate or severe PE was 230 days in the Linhaliq treatment group as compared to 163 days in the placebo group. This increase in the median time to first PE was statistically significant. In the key secondary efficacy endpoint, there was a 37% reduction in the frequency of PE's over the 48-week treatment period in the Linhaliq treatment group compared to the placebo group. This result was also statistically significant.

In ORBIT-3 the median time to first mild, moderate or severe PE was 221 days in the Linhaliq treatment group as compared to 136 days in the placebo group. This increase in the median time to first PE was similar to ORBIT-4 but was not statistically significant. In the key secondary efficacy endpoint, there was a 13% reduction in the frequency of PE's over the 48-week treatment period in the Linhaliq treatment group as compared to the placebo group. This result was also not statistically significant.

However, the analyses of combined data from both studies resulted in a statistically significant reduction in the number of PE's over the 48-week double-blind period representing a 27% reduction in PE's over the period, according to Aradigm.

Linhaliq is designated an Orphan Drug and Qualified Infectious Disease Product by the FDA.

An advisory panel, which met on November 16, 2017, and reviewed Bayer's ciprofloxacin dry powder for inhalation (Cipro DPI) for the treatment of non-cystic fibrosis bronchiectasis had voted against its approval citing inconsistent data, drug-resistance concern and failure to meet all but only one of the primary endpoints in two phase III trials.

Will Aradigm's Linhaliq get the FDA panel's backing or will it go Bayer's way? The D-Day is now just a matter of days away.

The FDA's final decision on Linhaliq is expected on January 26, 2018. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

ARDM touched a new 52 week high of $7.09 in intra-day trading on Thursday (Dec.28) before closing at $7.05, up 16.34%.