Kiniksa Pharmaceuticals Ltd(NASDAQ:KNSA) just announced interim data from an open-label Phase 2 clinical trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein that blocks IL-1α and IL-1β signaling, in subjects with symptomatic recurrent pericarditis.
According to the release, the data show reductions in both inflammation and reported pain after the first dose which persisted throughout the treatment period. The company also reported that it has initiated RHAPSODY, a pivotal Phase 3 clinical trial in recurrent pericarditis, and is actively recruiting and screening subjects.
Kiniksa Pharmaceuticals Ltd (NASDAQ:KNSA) trumpets itself as a clinical-stage biopharmaceutical company that focuses on the discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need worldwide.
Its clinical-stage product candidates include Rilonacept, which is in Phase II clinical trials for the treatment of recurrent pericarditis, a debilitating inflammatory cardiovascular disease; Mavrilimumab, a monoclonal antibody for the treatment of giant cell arteritis; and KPL-716, a monoclonal antibody, which is in Phase 1a/1b clinical trial for the treatment of prurigo nodularis and atopic dermatitis.
Rilonacept is a weekly, subcutaneously-injected, recombinant fusion protein that blocks IL-1α and IL-1β signaling. Rilonacept was discovered and developed by Regeneron and is approved by the FDA under the brand name ARCALYST® for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), which includes Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome. IL-1 blockade may interfere with immune response to infections.
Serious, life-threatening infections have been reported in patients taking ARCALYST. ARCALYST should be discontinued if a patient develops a serious infection. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections. Kiniksa exclusively licensed rilonacept from Regeneron for recurrent pericarditis and certain other indications. Rilonacept in recurrent pericarditis is an investigational drug.
Kiniksa Pharmaceuticals, Ltd. was founded in 2015 and is based in Hamilton, Bermuda.
The Bucket in Gleam Street
As we discussed earlier, KNSA just announced interim data from an open-label Phase 2 clinical trial of rilonacept, a weekly, subcutaneously-injected, recombinant fusion protein that blocks IL-1α and IL-1β signaling, in subjects with symptomatic recurrent pericarditis.
The stock is up on the news. Overall, shares of KNSA have rallied about 18% over the past week. That sets up an interesting context for the action tomorrow.
“We are pleased to announce the commencement of RHAPSODY, a pivotal Phase 3 clinical trial of rilonacept in recurrent pericarditis,” said John F. Paolini, MD, PhD, FACC, Chief Medical Officer of Kiniksa. “RHAPSODY was supported by the interim data from our Phase 2 pilot study, which showed that rilonacept provided a reduction in both inflammation and reported pain as well as a durability of response in subjects with a symptomatic recurrent pericarditis episode. We believe we are now closer to providing a potential treatment option for patients suffering from recurrent pericarditis, a disease with significant unmet medical need.”
Kiniksa Pharmaceuticals Ltd (NASDAQ:KNSA) had no reported sales in its last quarterly financial data. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($337.9M against $28M).