The US FDA granted fast track designation to Palisade Bio Inc (NASDAQ:PALI)’s LB1148 to treat adhesions following pelvic or abdominal surgery.
In January 2021, Palisade previously received fast track designation for its LB1148 from the FDA to cure postoperative GI dysfunction in pediatric patients with gut hypoperfusion injury.
Clinical path for oral formulation to treat surgical adhesions
CEO of Palisade, Tom Hallam, said fast track designation is another milestone for its LB1148. It demonstrates the need for patients to cure adhesions arising from post-surgical complications. The company would closely work with the US FDA for a clinical path for its LB1148 to reduce surgical adhesions.
Tom said LB1148 would benefit hospitals, physicians, and patients in reducing adhesions. The fast track designation allows the company to expedite the development/ review of the application for LB1148 for the US FDA approval.
Around 90% of the patients suffer from adhesions after undergoing intra-abdominal surgery.
Healthcare costs at $2.3 billion
Around 19% of the patients, who underwent abdominal surgery, experience adhesion-related complications like female infertility, chronic pain, and SBO (small bowel obstruction). It results in healthcare costs of more than $2.3 billion annually. Sometimes physicians carry out adhesiolysis to prevent the formation of adhesions.
The oral formulation – LB1148 neutralizes the potent digestive protease activity. Patients suffer from temporary loss of normal GI (gastrointestinal) function following the release of DP (digestive proteases).
LB1148 inhibits the activity of digestive proteases and mitigates the damage to GI tissues. It also ensures the quick return of GI function to normal.
Palisade expects to publish data of phase 2 clinical trial of LB1148 to mitigate adhesions in 2021.
Palisade raised $20 million through a private placement, as announced previously in April 2021.
Leading BioSciences merges with Seneca Biopharma
Leading BioSciences, Inc, is combined with Seneca Biopharma, Inc on April 21, 2021, to create a new company called Palisade Bio, Inc. The shareholders of Seneca approved the merger deal.
Palisade will trade under the ticker – PALI on the NASDAQ with effect from April 28, 2021.
Tom said the integration is a significant milestone for all investors in the newly formed Palisade. It enjoys the financial flexibility offered by Seneca.
