SUZHOU, China, Dec. 1, 2022 /PRNewswire/ — Kintor Pharmaceutical Restricted (“KintorPharma”, HKEX: 9939), a clinical-stage biotechnology firm growing modern small molecules and organic therapeutics, in the present day introduced outcomes of section II scientific trial of pyrilutamide (KX-826), a possible first-in-class topical drug developed by the corporate, in China for the therapy of grownup feminine androgeneticalopecia (AGA). Within the research, KX-826 has demonstrated clinically significant and statistically important enchancment in hair development as measured by goal space non-vellus hair depend (TAHC). As well as, its security profile was favorable.
This trial is a multi-center, randomized, double-blind, placebo-controlled research designed to guage the efficacy and security of KX-826 for the therapy of AGA in feminine adults. Professor Jianzhong Zhang, chairman of the Division of Dermatology, Peking College Individuals’s Hospital, is the main principal investigator (Main PI). The first endpoint for the trial is the change from baseline versus placebo in TAHC on the finish of week 24.
A complete of 160 feminine AGA sufferers who’ve met Savin Scale (D3-D6) have been enrolled within the section II scientific trial. 119 sufferers have been randomly assigned to 4 therapy teams, together with KX-826 2.5mg (0.25%) as soon as each day (QD), KX-826 2.5mg (0.25%) twice each day (BID), KX-826 5mg (0.5%) QD and KX-826 5mg (0.5%) BID; and 41 sufferers have been assigned to placebo teams (QD and BID). The outcomes haven proven that,
- The TAHC of the KX-826 5mg (0.5%) QD group has elevated by 11.39 hair counts per cm2 in contrast with the placebo group from baseline after the therapy of 24 weeks, which was statistically important (P=0.0087). As well as, KX-826 has demonstrated efficacy as early as on the finish of week 12.
- The really helpful dose for section III scientific trial for feminine AGA in China is decided as KX-826 5mg (0.5%) QD.
- The general security profile of KX-826 was favorable. Nearly all of therapy emerged hostile occasions (TEAE) have been delicate and just like these of placebo. No TEAE resulted in affected person withdrawal from the trial, nor dying was reported.
Professor Jianzhong Zhang, chairman of the Division of Dermatology, Peking College Individuals’s Hospital, commented, “AGA is the most typical kind of hair loss tremendously affecting female and male adults. The market potential for unmet medical wants is big. Particularly, therapy choices for feminine AGA adults are extra restricted than these for male AGA adults. We’re happy to announce that the first-in-class topical drug, KX-826, has proven a superb efficacy and security profile within the feminine AGA section II trial. This outcome paves the way in which for the pivotal research which might kick off very quickly. In the meantime, the enrollment of pivotal research of KX-826 for treating male AGA adults is ongoing in China. We sit up for KX-826’s commercialization to supply advantages to each female and male AGA adults worldwide.”
Dr. Youzhi Tong, founder, Chairman and Chief Government Officer of Kintor Pharma, commented, “1) In contrast with the scientific trial design for male AGA adults research, it is more difficult for the section II scientific trial of treating feminine AGA adults, as a result of adjustments of their hairline form, hair loss ranking and hair density and lack of detectable biomarkers; 2) Minoxidil and Finasteride can be found for male AGA adults, nevertheless, for feminine AGA adults, the topical therapy is restricted to Minoxidil solely; 3) Even the incidence charge is 1 in 20 for feminine AGA adults, which is lower than that for male, girls have the next want for look and are keen to pay. Due to this fact, the market dimension of treating feminine AGA is massive in each China and abroad. We count on to kick off the pivotal research in China quickly. Within the meantime, we will proceed to actively search for companions to broaden into the worldwide market. We hope that KX-826 could be an efficient and protected first-in-class drug for female and male AGA adults across the globe as quickly as potential.”
About KX-826
KX-826 is an androgen receptor (AR) antagonist and a possible first-in-class topical drug for the therapy of AGA and pimples vulgaris. For the AGA indication, on 8 September 2021, Kintor Pharma introduced that the first endpoint of the section II scientific trial of KX-826 on male adults was met, with outcomes demonstrating a optimistic efficacy and security profile. Kintor Pharma is continuous to conduct a section III scientific trial of KX-826 in China and has accomplished the enrollment of sufferers in its section II scientific trial of KX-826 within the US for male AGA adults. For the pimples vulgaris indication, Kintor Pharma has accomplished the enrollment of sufferers in its section II scientific trial of KX-826 in China.
About Kintor Pharmaceutical Restricted
Kintor Pharmaceutical Restricted is growing and commercializing a sturdy pipeline of modern small molecule and organic therapeutics for androgen-receptor-related illness areas with unmet medical wants, together with COVID-19, prostate, breast and liver cancers, alopecia and pimples. For extra info, go to www.kintor.com.cn.
SOURCE Kintor Pharma
