Positive PhIII results in hand, Concert Pharma forges ahead with NDA and commercialization plans for hair loss drug – Endpoints News
Concert Pharmaceuticals has been waiting to tout Section III data amidst a sell-off of the majority of its pipeline to Terran Biosciences and several other occasions for the biotech. And on Monday, the company rolled out the pink automobilepet.
Concert unveiled topline results from its second Section III clinical trial, dubbed THRIVE-AA2, evaluating its oral candidate curleasely referred to as CTP-543 in grownup patients with moderate to severe alopecia spaceta. The candidate is an inhibitor of Janus kinases JAK1 and JAK2.
The primary efficacy finishlevel, the percentage of patients achieving a certain rating on an alopecia severity scale after 24 weeks, was met with statistical significance in each the 8 mg twice-daily and 12 mg twice-daily dose teams relative to positionbo. Deal withment of the candidate was also generally well-tolerated.
Actwineing to the company, these enrolled have been required to have not less than 50 percent scalp hair loss as measured by the SALT scale (with a rating of 100 repredespatcheding complete scalp hair loss and zero as no loss). The average baseline SALT rating throughout all patients was approximately 87.9.
Statistically significant professionalportions of patients deal withed with either dose levels achieved a SALT rating of 20 or much less. Concert mentioned 38.3% hit the rating within the 12 mg twice-daily dose group and 33% within the 8 mg twice-daily dose group. The examine ultimately webted a p-value of p<0.0001 for each doses.
The positive data have been welcome information to investors, because the Massachusetts biotech’s inventory value $CNCE rose over 6% since opening.
“Based mostly on the results from our Section 3 professionalgram, we believe CTP-543, if approved, might be a best-in-class deal withment option for alopecia spaceta and have a distinct therapeutic professionalfile with features which can be important to patients, including the percentage of patients with clinically-meaningful hair reprogress, patient satisfaction levels, and hair reprogress charges,” mentioned Concert’s chief development officer James Cassella.
On the again of the results, Cassella mentioned the company is now looking to prepare an NDA submission to the FDA within the first half of subsequent 12 months in addition to plans to commercialize the drug.
Concert’s path to the FDA comes as Eli Lilly was the first across the line in June, as Olumiant (baricitinib) webted FDA approval in a once-daily capsule in three dose levels, placing prespositive on the biotech now to get approval for its candidate.
Secondary finishfactors included 47% of patients within the 8 mg twice-daily group and 52% of patients within the 12 mg twice-daily group saying they have been “satisfied” or “very satisfied” with the deal withment, compared to 2% of patients within the placebo group.
The candidate and the company itself have been on a wild journey. In 2018, the drug’s data initially didn’t maintain up in opposition to Pfizer’s candidate, however execs decided to forge forward and obtained breakthrough therapy designation in 2020. CTP-543 is likely one of the company’s major hopes because the company hit a significant velocity bump last year when a Section II trial for its schizophrenia professionalgram flopped, causing the company to ax the program and its inventory to tank by 40%.
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