Insmed Inc. (INSM) said Friday that the US Food and Drug Administration has lifted the clinical hold on its investigational drug Arikace in patients with non-tuberculous mycobacteria lung disease. Following the news, Insmed shares gained more than 33 percent on the Nasdaq.
The New Jersey-based company said it continues to hold talks with the FDA regarding the clinical hold FDA has placed on Arikace in Cystic Fibrosis, or CF patients with Pseudomonas lung infections.
According to Insmed, the FDA previously requested the company to conduct a phase 2 clinical trial of Arikace in adult patients with non-tuberculous mycobacteria (NTM) to prove the drug's efficacy and safety before proceeding with a phase 3 clinical trial.
As part of its assessment of the Arikace program, including the phase 2 trial of the drug in NTM patients, the company indicated continued communication with FDA regarding the CF clinical hold.
Insmed CEO Timothy Whitten said, "We are pleased that FDA has lifted the clinical hold on the Arikace development program in NTM."
"Insmed continues to work closely with regulatory authorities regarding the development program for ARIKACE. We are initiating the work required to begin the 9-month dog study during the second quarter and are continuing our dialogue with FDA regarding the CF clinical program."
Arikace is a liposomal formulation of amikacin, an FDA-approved IV aminoglycoside antibiotic that has proven efficacy in the treatment of gram-negative infections such as Pseudomonas, as well as NTM.
Nontuberculous mycobacteria lung infections can cause severe pulmonary disease for which there are currently limited effective treatments. NTM is found in the environment, e.g., soil and water, and can lead to serious infections, the most common of which occur in the lung.
Cystic fibrosis is an inherited disease that is often diagnosed before the age of two. There are over 70,000 patients living with CF in the US and Europe. CF is said to cause a thick, sticky mucous to form in the lungs, creating an ideal environment for various pathogens, such as Pseudomonas, to form and grow.
Additionally, Insmed said that its Iplex inventory has now been depleted, and at present, about 10 patients remain on the drug. Iplex was developed by Insmed for the treatment of growth failure in children with severe primary IGF-I deficiency or with growth hormone gene deletion (GH) who have developed neutralizing antibodies to GH. Regarding potential future Iplex initiatives, the company said it is currently evaluating possible out-licensing opportunities for the drug.
INSM is trading at $5.08, up $1.28 or 33.68%, on a volume of 2.4 million shares on the Nasdaq.
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