Lumosa Therapeutics Co Ltd (順天醫藥) on Tuesday said that it gained approval from the Food and Drug Administration (FDA) to conduct phase Ib and II clinical trials for its treatment of uremic pruritus, LT5001.
The company was allowed by the regulator to skip phase Ia testing, as LT5001 is derived from its a long-acting analgesic injection LT1001, which received approval for sales in Taiwan in 2017, communications manager Vincent Kuo (郭晏銓) told the Taipei Times by telephone.
Lumosa would soon proceed with the phase Ib trial, which is expected to be completed within one year, Kuo said.
The company would then move to the phase II trial after the agency approves its phase Ib test results, he said.
LT5001 aims to fulfill unmet medical needs of patients, given a lack of effective treatment for uremic pruritus, the company said in a statement.
Existing treatments are limited to antihistamines, steroids or moisturizing agents, with temporary relief or side effects such as drowsiness, it said.
LT5001 could inhibit the transmission of itch signals at peripheral sites when applied to the skin to resolve or significantly reduce itchiness, it added.
Uremic pruritus is a common and distressing complication of chronic kidney disease and end-stage renal disease associated with sleep disturbance and depression, the company said, adding that the treatment has a large market, as there are millions of dialysis patients worldwide.
On average, 42 percent of patients with chronic kidney disease and end-stage renal disease have uremic pruritus, it said, citing a 2006 global study of 18,000 hemodialysis patients.
The ratio dropped to about 40 percent in 2016, it added.
For the first 11 months of last year, Lumosa’s revenue declined 51 percent year-on-year to NT$24.64 million (US$818,442), company data showed.
The company reported net losses of NT$145 million in the first three quarters of last year, compared with losses of NT$61 million a year earlier, due to falling revenue and high research costs.
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