After landing funds from Royalty, Cytokinetics announces aficamten PhII results; Polish CRO Selvita restructures in search for new growth
California-based Cytokinetics announced that positive results from a Phase II trial of aficamten showed positive results in patients battling hypertrophic cardiomyopathy.
The third cohort of the REDWOOD-HCM trial showed substantial reductions in the average left ventricular outflow tract gradient in patients whose background included being treated with disopyramide and a beta-adrenergic blocker. Each patient received up to three doses daily.
Results showed that there were no instances of left ventricular ejection fraction below 50%. Aficamten is an investigational cardiac myosin inhibitor. Treatment in the trial lasted 10 weeks, with a 4-week follow-up period coming in after the last dose. Thirteen patients were enrolled, and all of them completed the study on treatment, Cytokinetics said.
In a statement, EVP of R&D Fady Malik said:
These results represent the first report of patients with obstructive HCM treated with a combination of a cardiac myosin inhibitor and disopyramide and support our plan to include this patient population in SEQUOIA-HCM, our Phase 3 trial, which is important given these patients have exhausted other available medical therapies. We look forward to initiating screening of patients in SEQUOIA-HCM soon and look forward to sharing these results from Cohort 3 with the medical community in April.
Earlier this month, Royalty Pharma agreed to lend up to $300 million to support the commercialization of omecamtiv mecarbil, Cytokinetics’ lead candidate, and the development of aficamten. In return, Royalty is due a 4.5% royalty on sales for up to $1 billion, and 3.5% on sales above $1 billion. — Kyle Blankenship
Polish CRO plots restructure, reorienting leadership team
Polish CRO Selvita is tearing down and rebuilding its business with plans to completely rejigger its leadership team as it hunts for growth, the small firm said Tuesday.
First, the firm is planning to integrate its “drug discovery area, integration of business development activities, and creation of a department supporting the management of operations and investments,” according to a release. That unit will be led by Adrijana Vinter, who was most recently a managing director at Fidelta.
Next, the firm will also integrate its sales and business unit. That area will be helmed by Milosz Gruca, who will take the CCO role.
Selvita also plans to add a new R&D facility in Krakow that will eventually hold up to 1,000 researchers, the company said. — Josh Sullivan