Patients who have chronic kidney disease face permanent kidney damage and the prospect of end-stage renal failure. Clinical-stage drug developer Tricida is trying to bring patients who suffer from this condition a new treatment and it now has $55 million in new capital to continue its work.
The Series C round brings the South San Francisco, California-based company’s total fundraising haul to $95 million. It comes 16 months after the company closed a $30 million Series B round. New investor Longtitude Capital led the latest round, joined by another new investor, Vivo Capital. Existing investors OrbiMed, Sibling Capital Ventures, and Limulus Venture Partners also participated in the Series C investment.
Tricida declined to comment about the funding beyond its news release, which said that the capital will be used to finance late-stage clinical trials of its lead drug candidate, TRC101.
Tricida is currently evaluating its compound in 100 patients in a Phase 1/2 clinical trial, which combines the first two phases of clinical trials in a single study. In the news release, the company said that trial is nearing completion and that Tricida is preparing for a Type B meeting with the Food and Drug Administration later this year to discuss the compound’s safety and efficacy in the study. Type B meetings are held at the end of a Phase 2 study and in advance of a Phase 3 trial. The FDA typically schedules these meetings within 60 days of a written request.
Chronic kidney disease is damage to kidneys that can be caused by diabetes and high blood pressure, according to the American Kidney Fund. The organization estimates that 31 million Americans are living with the condition. Chronic kidney disease causes permanent damage that can worsen over time, potentially leading to kidney failure or end-stage renal disease. Patients whose kidneys fail need dialysis or a kidney transplant.
Tricida said on its website that one of the characteristics of chronic kidney disease is the accumulation of electrolytes that are produced by the body’s natural metabolic and dietary processes. These electrolytes include phosphate, potassium, and sodium. Tricida said that TRC101 treats chronic kidney disease by restoring the balance of such electrolytes. Other drugs are drugs available to restore electrolyte imbalance, including Renagel and Renvela, both marketed by Sanofi. Chronic treatments for end-stage renal disease patients generate nearly $1 billion in global sales, according to Tricida.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Like the Sanofi drugs, TRC101 isn’t absorbed by the body, Tricida said. The Tricida drug is designed to work in the gastrointestinal tract. Because the drug is not broken down and absorbed by the body but is instead cleared by the digestive system, Tricida said this non-absorbed feature could improve the compound’s safety profile. The drug would be used in patients who have not yet reached the point of needing dialysis treatment.
TRC101 is the product of Tricida’s own in-house drug discovery, and the company has moved quickly in its development efforts. Less than two years ago, Tricida announced that it discovered TRC101, which it said it would pursue as a potential treatment for diseases of the heart and kidneys.
In March 2015, Tricida announced its $30 million Series B round, which the company used to lay the groundwork for clinical testing in chronic kidney disease. Tricida CEO Gerrit Klaerner said this week that the company is ahead of schedule in establishing the compound’s clinical proof of concept. Now the company is already looking beyond late-stage studies as it considers the drug’s commercialization plans.
“The company’s anticipated development path and commercial positioning in pre-dialysis patients allow us to consider multiple options, including eventually launching TRC101 with our own sales force,” Dr. Klaus Veitinger, chairman of Tricida’s board of directors and a venture partner at investor OrbiMed, said in a prepared statement.
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