REDWOOD CITY, Calif.--(BUSINESS WIRE)--LifeMax Laboratories, Inc. (“LifeMax”), a private company focused on developing first-in-class or best-in-class therapeutics for the treatment of orphan diseases that have few or no therapeutic options, today announced that the Food and Drug Administration (FDA) granted fast track designation to LM-030, an investigational therapy licensed from Novartis and currently in a Phase 2/3 pivotal clinical trial for the treatment of Netherton Syndrome. LM-030 previously received orphan drug designation (ODD) from both the FDA and European Commission as well as rare pediatric disease designation (RPD) from the FDA.
“We are very pleased to have received the fast track designation for LM-030, which, together with ODD and RPD, is a huge boon to the overall development plan. Netherton Syndrome is a serious and debilitating disease that is potentially life threatening, especially in infants. LM-030 is the only program in clinical development for Netherton and could potentially become the first approved targeted therapy. This fast track designation will help expedite its development and bring this much needed therapy to patients in a timely manner,” said Larry Hsu, LifeMax’s Co-founder and CEO, an industry veteran who previously founded and built Impax Laboratories into a publicly traded multi-billion-dollar company.
Fast track designation is granted by FDA to a drug that is intended to treat a serious condition and has nonclinical or clinical data demonstrating the potential to address such unmet medical need. The benefit of fast track designation includes, but not limited to, opportunities for frequent interaction with the FDA, eligibility for priority review and rolling review.
About Netherton Syndrome
Netherton Syndrome is a severe autosomal recessive disease due to mutations in the SPINK5 gene. It is clinically characterized by congenital erythroderma, “bamboo hair” and immune system abnormalities. It can be life-threatening in pediatrics due to an impaired skin barrier that leads to severe dehydration, hypernatremia, hypothermia, gross weight loss and sepsis. Failure to thrive is common in childhood as a result of chronic erythroderma, persistent cutaneous infection, malnutrition and metabolic disorders. The severity of the skin abnormality in older patients can fluctuate over time. Most Netherton Syndrome patients are also inflicted with immune system-related disorders such as food allergies and asthma.
Though the exact prevalence of Netherton Syndrome is not well documented, it has a reported prevalence of 1-9 per 1,000,000.
About LifeMax Laboratories Inc.
LifeMax Laboratories, Inc. ( www.lifemaxlabs.com), a wholly-owned subsidiary of LifeMax Healthcare International Corporation ( www.lifemaxhealthcare.com), is a clinical-stage biotech company focused on treating orphan diseases having few or no therapeutic options. LifeMax is applying its expertise and in-depth experience with drug development and commercialization to advance its portfolio of first-in-class or best-in-class assets targeting the underlying genetic abnormality and addressing critical unmet medical needs.