FDA Approves IND Application for Traumakine

Clinical stage biopharmaceutical company Faron Pharmaceuticals Ltd. announced this morning that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for Traumakine (FP-1201-lyo) for the treatment of Acute Respiratory Distress Syndrome (ARDS).

The FDA has already proposed that Faron can proceed directly to the submission of the Biologics License Application (BLA) portion of the regulatory process, assuming its two ongoing Phase 3 trials yield positive results. Both the INTERST study in Europe and the MR11A8-2 study in Japan are evaluating the efficacy and safety of FP-1201-lyo in patients diagnosed with moderate or severe ARDS.

ARDS is a rapidly progressing disease that occurs in patients who are already critically ill. The primary complication associated with the condition is the leakage of fluid into the lungs, making it difficult or impossible to breathe. According to the American Lung Association, risk factors include: a history of smoking cigarettes, oxygen use for a pre-existing lung condition, recent high-risk surgery, obesity, low protein in the blood, alcohol abuse, and recent chemotherapy.

Faron intends to conduct a small open label study in the U.S. to assess the use of Traumakine for pharmacological purposes. The IND will permit opening of clinical activities throughout the country, the first of which will target the drug in moderate and severe ARDS patients, especially with end organ (kidney and liver) failure.

Additionally, Faron expects to publish top-line data from the INTERST study in the first half of 2018.

"We are very pleased to receive this IND approval from the FDA which will allow us to further advance our Traumakine plans in the US,” said Dr Markku Jalkanen, CEO of Faron in a press release. “It also allows rolling dossier build up for FDA, which can speed up the final BLA acceptance. With data expected in H1 2018 and, following previous guidance from the FDA, we remain hopeful that we can expedite Traumakine's route to market addressing this significant unmet medical need in terms of reducing mortality and providing savings for healthcare systems."

There are currently no pharmacological treatments approved for ARDS, and the reported mortality rate of patients with ARDS is estimated to be 30-45%. Traumakine is also currently being evaluated in a Phase II trial for the Rupture of Abdominal Aorta Aneurysm (RAAA).

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