Keros Therapeutics, Inc. (KROS) stock prices were down by 11.98% shortly after market trading commenced on June 23rd, 2021, bringing the price per share down to USD$46.28.
Success of Phase 2 Trial
June 22nd, 2021 saw the company announce preliminary results rom Cohorts 1 and 2 of its Phase 2 clinical trial. The trial is designed to evaluate KER-050 for the treatment of anemia and thrombocytopenia in patients with very low- to intermediate-risk myelodysplastic syndromes. Patients may or may not have ring sideroblasts and may or may not have been previously treated with an erythroid stimulating agent.
Details of the Trial
The ongoing trial is an open-label, two-part, multiple ascending dose trial that is designed to assess the trial’s safety, tolerability, pharmacokinetics, and pharmacodynamics of the treatment in MDS patients. 12 patients had received at least one dose of the treatment as of May 14th, 2021, 9 of whom had been administered the treatment for a period of 8 weeks. Patients in Cohort 1 were administered 0.75mg/kg of KER-050, while Cohort 2 patients received 1.5 mg/kg. Both cohorts were treated once every four weeks for 12 weeks.
Scope of KER-050
The preliminary results were promising, with increases being observed in hematological parameters in the two lowest Part 1 dose cohorts, who were dosed monthly, in both RS and non-RS patients with MDS. This initial success signals proof-of-concept of the treatment in patients with very low- to intermediate-risk MDS, which support the scope of KER-050 as a treatment for disease associated with ineffective hematopoiesis.
Expansion of Trial
Furthermore, based on the success of the preliminary results, the company plans to extend the duration of the trial from 12 weeks to up to two years. This is to better facilitate the defining of response rate following six months of treatment with KER-050, as well as to confirm the durability of response. KROS also plans to update the protocol to expand the size of Part 2 of the trial to consolidate response rates, as well as to help guide the design of the expected registration program. Part 2 trial designs are expected by the end of 2021.
Future Outlook for KROS
Armed with the success of its clinical trial, KROS is poised to capitalize on the opportunities afforded to it to push for the commercialization and proliferation of KER-050. The company is keen to usher in further growth with the potential of its expanded footprint. Current and potential investors are hopeful that management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.
