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March 10, 2021, 1:05 p.m. EST

Vertex to begin Phase 1/2 trial of treatment for people with type 1 diabetes

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By Jaimy Lee

Shares of Vertex Pharmaceuticals Inc. /zigman2/quotes/202259802/composite VRTX +1.23% were down 0.2% in trading on Wednesday after the company said it started an early-stage clinical trial for its experimental treatment for people with type 1 diabetes. It also said the therapy received a fast-track designation from the Food and Drug Administration. The Phase 1/2, single-arm, open-label study will be conducted at multiple sites in the U.S. and aims to enroll 17 participants. Vertex gained access to the therapy through its roughly $1 billion acquisition of Semma Therapeutics Inc. in 2019. Vertex's stock is down 7.4% over the past year, while the S&P 500 /zigman2/quotes/210599714/realtime SPX +0.01% has rallied 41.1%. The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880. Approximately 17 patients will be enrolled in the clinical trial. About Type 1 Diabetes T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death. Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia often results because of the difficulty in balancing the different factors that impact glucose levels, including insulin, diet and exercise. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal. Over time, patients with T1D can develop impaired awareness of hypoglycemia, meaning they are no longer able to perceive the early signs of a hypoglycemic event, which can be dangerous and result in life threatening events. There are currently limited treatment options beyond insulin for the management of T1D.

/zigman2/quotes/202259802/composite
US : U.S.: Nasdaq
$ 258.59
+3.14 +1.23%
Volume: 1.55M
May 20, 2022 4:00p
P/E Ratio
27.25
Dividend Yield
N/A
Market Cap
$66.14 billion
Rev. per Employee
$2.04M
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/zigman2/quotes/210599714/realtime
US : S&P US
3,901.36
+0.57 +0.01%
Volume: 3.00B
May 20, 2022 5:03p
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