FDA fast tracks novel drug for reducing adhesions after abdominal surgery
USA: The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the Palisade Bio's investigational drug LB1148 for the reduction of adhesions following abdominal or pelvic surgery.
Under the FDA Modernization Act of 1997, designation as a Fast Track product means the FDA can take action to expedite both the development and the review of the application for approval.
"Fast Track Designation represents another positive step for the clinical development of LB1148 and is a clear recognition of the serious need that exists for patients looking to avoid long-lasting and serious complications from post-surgical adhesions," Tom Hallam, chief executive officer of Palisade Bio said in a statement. "We look forward to working closely with the FDA to maintain an open dialogue about the clinical path forward with LB1148, not only for the reduction of surgical adhesions indication, but also in the other post-op indications where it is being investigated in the clinic. We believe that by reducing adhesions, LB1148 has the potential to benefit patients, physicians, hospitals, and payers alike."
LB1148 is an oral formulation of a broad spectrum serine protease inhibitor designed to neutralize the activity of digestive proteases released from the gut during surgery. The Company believes LB1148 has the potential to reduce damage to gastrointestinal (GI) tissues by inhibiting these digestive proteases, thereby accelerating the return of normal GI function and shortening the duration of postoperative hospital stays.
A multicenter, randomized, double-blind, placebo-controlled phase 2 trial (PROFILE) has been initiated to assess the efficacy, safety and tolerability of LB1148 for the treatment of intra-abdominal adhesions and postoperative ileus in approximately 120 adults undergoing elective bowel resection.
LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to reduce damage to GI tissues, accelerate the time to return of normal GI function, and shorten the duration of costly post-surgery hospital stays.