Concert Pharmaceuticals Announces Presentation of Deuruxolitinib THRIVE-AA1 Phase 3 Study Results in Alopecia Areata During World Congress for Hair Research
New Analyses Presented on the Effect of Baseline Severity and Duration of Current Episode of Hair Loss on Scalp Hair Regrowth
“These new data analyses are important to inform our treatment of patients with varying degrees of disease severity and duration of current episode of hair loss. For patients receiving deuruxolitinib in THRIVE-AA1, the data show meaningful and significant improvement in patients with the most severe disease and those with longer duration of current episode. The data show, however, that more patients succeed with treatment when they are treated before they lose all of their scalp hair and when they are treated earlier in an episode of severe loss” stated
In THRIVE-AA1, significant improvements in scalp hair regrowth compared to placebo were achieved at 24 weeks for patients taking 8 mg twice-daily and 12 mg twice-daily doses of deuruxolitinib, as previously disclosed in the positive topline results reported by Concert earlier this year. Treatment with deuruxolitinib was generally well tolerated.
The newly presented analyses on disease severity and duration of current episode of hair loss from THRIVE‑AA1 include:
- For patients with an absolute Severity of Alopecia Tool (SALT) score less than 95 at baseline, 43% and 57% of the 8 mg twice-daily and 12 mg twice-daily deuruxolitinib dose groups, respectively, achieved a SALT score of 20 or less at Week 24, compared to 1% of patients in the placebo group (p<0.0001). The onset of effect was significant as early as Week 8 for both doses (p<0.001).
- For patients with a SALT score greater than or equal to 95 (representing complete or nearly complete scalp hair loss) at baseline, 20% and 30% of the 8 mg twice-daily and 12 mg twice-daily deuruxolitinib dose groups, respectively, achieved a SALT score of 20 or less at Week 24, compared to 0% of patients in the placebo group (p<0.0001). The onset of effect was significant as early as Week 12 for both doses (p<0.01).
- For patients whose duration of current episode of hair loss was less than 4 years, the proportion of patients achieving a SALT score of 20 or less by Week 24 was 33% and 48% in the deuruxolitinib 8 mg twice-daily and 12 mg twice-daily dose groups, respectively, compared to 1% of patients in the placebo group (p<0.0001).
- For patients whose duration of current episode of hair loss was greater than or equal to 4 years, the proportion of patients achieving a SALT score of 20 or less by Week 24 was 23% and 29% in the deuruxolitinib 8 mg twice-daily and 12 mg twice-daily dose groups, respectively, compared to 0% of patients in the placebo group (p<0.0001).
Deuruxolitinib was generally well-tolerated in THRIVE-AA1, consistent with its other Phase 2 and Phase 3 studies. The most common (≥5%) side effects in any dose group were headache, acne, upper respiratory infection, increased creatine kinase levels, COVID-19 infection and nasopharyngitis. Upper respiratory infections were greater in the placebo group than in either of the deuruxolitinib dose groups. No pulmonary embolisms or deep vein thromboses were observed in the trial. One patient treated with the 8 mg twice-daily dose and one patient treated with the 12 mg twice-daily dose developed herpes zoster (shingles). Serious adverse events were reported in nine patients, with only one patient (in the 8 mg twice-daily dose group) having events (2) that were assessed as possibly related to treatment. Four patients who reported serious adverse events were in the placebo group.
The data presented at the
THRIVE-AA1 (NCT04518995) was a randomized, double-blind, placebo-controlled clinical trial in 706 adult patients age 18-65 with moderate to severe alopecia areata at sites in the
Patients enrolled in THRIVE-AA1 were required to have at least 50 percent scalp hair loss due to alopecia areata, as measured by SALT. A SALT score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss. The average baseline SALT score across all patients in THRIVE-AA1 was approximately 85.9 (corresponding to less than 15% average scalp hair coverage).
All patients who completed 24 weeks of treatment in THRIVE-AA1 had the opportunity to continue in a separate extension study to evaluate long-term safety and efficacy of deuruxolitinib. More than 95% of eligible patients in THRIVE-AA1 elected to roll into the extension study.
In THRIVE-AA1, significant improvements in scalp hair regrowth compared to placebo were achieved at 24 weeks for patients taking 8 mg twice-daily and 12 mg twice-daily doses of deuruxolitinib. Treatment with deuruxolitinib was generally well tolerated.
About Deuruxolitinib and Alopecia Areata
Deuruxolitinib (CTP-543) is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2. The
Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to approximately 1.5 million Americans at any given time.1 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited treatment options available for alopecia areata.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future expectations, plans and prospects, including, among others, statements about our expectations regarding the development of deuruxolitinib, and any other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation, timing and design of future clinical trials, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results, including safety profiles, from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for the timing of the submission of a New Drug Application, the availability of regulatory approvals and other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q filed with the
1 Benigno M. Clinical, Cosmetic and Investigational Dermatology 2020
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