Shanghai WD Pharmaceutical Co., Ltd. haε♠$βs recently successfully completed a ±→randomized, parallel, double-blindΩ←, placebo-controlled, mβ™∏ulti-center Phase IIε<' clinical trial of WD-1603 (carbidopa/≥₽levodopa controlled-release table←σ±£ts) for the efficacy<$ and safety in patients with✔∞↑£ Parkinson's disease. T₩α₩$he patients with early-stage Par↑£≈kinson's disease weα<  re randomized to receive 4 w←<✘eeks of treatment with WD-1603 25/10∞®→0 mg (low dose group), WD-16↓§®™03 25/150 mg (medium dose group)>↕σ&, WD-1603 2x25/100 mg (hig©•h dose group), or plaΩ‍$‌cebo. The efficacy was aק>€ssessed by blinded investigat☆§ors using the Movement Di σ♦ sorder Society-Unified Park™<inson's Disease Rating Scale Part I£₽"I and III (MDS-UPDRS-II andαλ←↕ III) on days 1st, 14th, and 27th of®× each treatment group. Steady-state p♥©$•harmacokinetic testi↔β↓<ng was performed on day 2φ≈8th for the WD-1603 treatment group‌$s.

The results showed that on ©↔days 14 and 27 after treatm $÷×ent, compared to baseline, ₹©the total MDS-UPDRS-II and III♥πφ scores of patients treated with WD-160↕↕₽¥3 decreased significantly by 7.2,♣®✘ 10.0, and 14.4 in the low, mediuπδm, and high groups, respective✘₽☆₩ly, demonstrating a dose-dependent  ​ relationship. The steady-state levodop®$©σa plasma concentration prof€♠αiles were flat across the €α‍‌three treatment groups, λ₹‌and the peak-to-trough fluctuatiφ≤∑on indices of levodopa for the WD-160 $÷3 25/100 mg, 25/150 mg, and ±λ2x25/100 mg dose groups were&'$ 1.27, 1.08, and 1.10, respectiππ€vely. These fluctuation  ®index values were significant↓÷ly lower than those of various oral l​≤≠evodopa formulations currently ÷♦available on the mark ☆≤et.

In conclusion, all the efficacy indica↔ ≠≠tors and steady-state plasma concentπλ≤$ration fluctuation indices of€λ©σ WD-1603 in the treatment of Parkinson&π≥#39;s disease met the expected target±σs, and the safety and tolerability we₹ ∑re good in all treatment gro•‌ λups.