HOME - LATEST NEWS - Corporate - Lumosa received LT5001 IND approval from TFDA for the treatment of uremic pruritus





Lumosa received LT5001 IND approval from TFDA for the treatment of uremic pruritus

Lumosa Therapeutics (Lumosa; code:6535.TWO) announced IND approval by the Taiwan FDA (TFDA) for the phase Ib/II study of its LT5001, a new drug under development for the treatment of uremic pruritus. The company will soon proceed with the phase Ib trial in Taiwan, which is expected to be completed within one year after initiation. Around 40% of hemodialysis patients with chronic kidney disease suffer moderate to severe uremic pruritus. These patients will benefit from LT5001 when it reaches market in the future.

There are millions of dialysis patients worldwide. For example, in the US, the largest pharmaceutical market in the world, one in every 7 Americans, or 3.7 million people in the country have chronic kidney disease, as stated by the US National Kidney Foundation, and in 2016, half a million Americans underwent hemodialysis. Uremic pruritus is a complication commonly seen in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD).

According to DOPPS (Dialysis Outcomes and Practice Patterns Study), a multinational continuous monitoring study, approximately 40% of patients undergoing hemodialysis suffer from moderate to severe uremic pruritus.

Uremic pruritus is a condition with strong “unmet medical need”. Existing treatments are limited to antihistamines, steroids, GABA analogues, moisturizing agents or phototherapies. However, for many patients, these treatments cannot completely resolve their conditions as the medicaments are either for temporary relief, have poor efficacy, possess side effects such as somnolence, or are unfit for long-term use due to side effects. Patients are left to continue facing poor quality of life caused by the condition.

LT5001 is a new drug developed by Lumosa for topical use. LT5001 can inhibit the transmission of itch signals at peripheral site when applied to the skin to resolve or significantly reduce itchiness. LT5001 has the advantage of being a much safer treatment with better efficacy and more convenient to use when compared to marketed products. LT5001 demonstrated continuous antipruritic effect for more than 4-hour in animal models and with a skin penetration rate of around 10%.

Following the IND approval for LT5001, the preparatory works for the clinical trial, such as application for IRB reviews, will soon start. The phase Ib/II trial will be completed in two stages as stated by the study plan.

According to the protocol, Lumosa will conduct the phase Ib trial first, then make necessary adjustments based on the study results before initiating the phase II study. The preliminary efficacy of LT5001 is expected to be demonstrated when the entire phase Ib/II trial is completed. The actual completion date of the clinical trial is dependent on the progress of the clinical program.

LT5001 is a product developed by Lumosa specifically for patients with unmet medical needs. Niche market product like LT5001 has been explored through product life-cycle management efforts at Lumosa, in addition, Lumosa has established a sustainable pipeline through its rSD product development strategy.