KX-826 Phase 2 Results
Purpose
The purpose of this study is to evaluate the safety, exposure, and efficacy of flecainide (KX-826) in the treatment of adult men with androgenetic alopecia (Androgenetic Alopecia) in China.
The objective of this study is to evaluate the safety, population exposure and efficacy of forretinoin (KX-826) in the treatment of adult male patients with Androgenetic Alopecia in China and to determine the recommended dose for a phase II trial.
Methods
This is a multicenter, randomized, two-word, placebo-controlled phase I clinical trial (KX-826-CN-1002).
The study is a phase I clinical trial (KX-826-CN-1002). Chinese adult men with Androgenetic Alopecia who met the Hamilton-Norwood classification (Class IIV, IV, YV) were randomized in a 1:1:1:1 ratio to the KX-826-CN-1002.
The patients were randomly assigned to the KX-826 2.5 mg (0.25% concentration) BID group, the 5 mg (0.5% concentration) QD group, the 5 mg (0.5% concentration)
BID group and the anandamide group (QD and BID groups).
The study design and efficacy endpoints are shown in Figure 1.
Figure 1 Study design and efficacy endpoints
Male, >18 years of age, in good general health
Clinical diagnosis of androgenic baldness; severity of baldness according to Hamilton-Norwood grading IIv, IV, YV
"Willingness to use the same shampoo and maintain the same hair shape, color, and length throughout the trial
"No parenting plan during the study period and within 3 months of the last dose and able to use effective contraception
Efficacy Endpoints:
* Primary endpoint; mean change from baseline in the target area of non-compulsory hair count (TAHC) after 24 weeks of treatment
* Secondary endpoints: change from baseline in TAHC after 6, 12, and 18 weeks of treatment; change from baseline in non-compassionate hair diameter (TAHW) in target area after 6, 12, 18, and 24 weeks of treatment
Change from baseline in TAHW; Hair growth assessment (HGA), including subject self-assessment, investigator assessment, and
Third-party physician assessment
Baseline patient characteristics
120 Chinese adult male Androgenetic Alopecia patients (mean height: 172.95 cm; mean weight: 75.05 kg), randomly assigned to
KX-826 2.5 mg (0.25% concentration) BID group (n=30), 5 mg (0.5% concentration) QD group (n=30), 5 mg (0.5% concentration)
(0.5% concentration) BID" (n=30) group, placebo QD group (n=10) and placebo BID group (n=20), with details of the patients
The baseline characteristics are shown in Table 1.
Security Analysis
*. Systemic exposure to KX-826 and its metabolite KX-982 reached steady-state after 14 days of topical application; transdermal blood concentrations were low in all dose groups.
The drug concentrations were low, with detectable KX-826 blood levels ranging from 0.3-4.1 ng/mL and KX-982 blood levels ranging from 0.4-10.4 ng/mL.
The blood levels of KX-982 were 0.4-10.4 ng/mL. The three dose reductions due to adverse events (AEs) were classified as Grade 1 contact dermatitis, Grade 2 rash, and Grade 1 smoldering rash according to the Common Adverse Event Evaluation Criteria 5.0.
Grade 1 rash and Grade 1 itch.
The incidence of adverse drug reactions (ADRs) was 16.1%, with the most common ADR being cancer itch (5.9%), followed by contact dermatitis (2.5%); and 1 ADR (2.5%).
The most common ADR was carcinoma itch (5.9%), followed by contact dermatitis (2.5%); one case had grade 3 hypertriglyceridemia and one case had grade 4 hypertriglyceridemia, but the baseline triglyceride value was high (6.99 mmolL).
(6.99 mmolL).
No serious adverse events, no serious ADRs and no deaths.
Conclusion
* Chinese adult male Androgenetic Alopecia patients (Hamilton-Norwood classification IIv, IV, YV) treated with topical KX-826 5 mg BID
After 24 weeks of treatment, there was a significant increase in TAHC in the target area compared to placebo, and the overall safety of the KX-826 dose groups was good.
No new safety events were observed outside of the expected period. In the 5 mg (0.5% concentration) BID group, TAHC increased by 15.34 roots/cm?at week 24 compared to the placebo group.
There was a statistically significant difference (p = 0.024).
The difference was statistically significant (p = 0.024). KX-826 5 mg BID is recommended as the dose for confirmatory clinical trials.
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