Clinical Catch-Up: Scandion Oncology, Edesa Biotech, Clovis & More

03 Oct 2022
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AntibodyBreakthrough TherapySmall molecular drugAHA
Scandion Oncology, Edesa, Clovis, Lexicon and Cytokinetics shared a string of positive news from their clinical trials on heart failure, cancer, COVID-19 and ARDS. Continue reading for details. Scandion mCRC Candidate Delivers Positive Phase II Safety Results Scandion Oncology announced the second part of its ongoing CORIST Phase II study on SCO-101 for metastatic colorectal cancer demonstrated favorable safety and tolerability outcomes. SCO-101, its lead compound, is being evaluated in combination with Folfiri chemotherapy to treat mCRC patients. There are 25 patients enrolled in Part II who have been observed after eight weeks of receiving the combination treatment. Scandion expects to enroll the first patient into Part III soon. Depending on dose escalation outcomes, Part III could be done by the third quarter of 2023. More details on a firmer timeline are expected in the first quarter of 2023. Edesa COVID-19 Candidate Fares Well For ARDS Patients Final results from Edesa Biotech's Phase II/Phase III clinical trial on EB05 for patients with or who are at risk of having COVID-19-induced acute respiratory distress syndrome demonstrated the drug's ability to achieve statistical significance in the said critically ill patient subgroup. EB05, its single-dose monoclonal antibody candidate, is designed to target the patient's own immune response instead of the virus itself. Success could mean a broad application of the treatment across various disease indications, including ARDS. Edesa has already submitted the Phase II CSR to the U.S. FDA as part of its review of whether it would proceed to Phase III. The Phase III trial already has approval in Canada, Colombia and Poland, where the company is enrolling participants. Clovis Phase III Study On Prostate Cancer Therapy Candidate Meets Primary Endpoint Top line data from Clovis Oncology's Phase III TRITON3 trial on Rubraca (rucaparib) as monotherapy for patients with chemo-naive metastatic castration-resistant prostate cancer achieved the primary endpoint of significant improvement in radiographic progression-free survival. Rubraca was compared with a control group in an open-label, multicenter study. This was made up of physicians' choice of abiraterone acetate, docetaxel or enzalutamide. Rubraca's safety pro consistent with the information on its label, while the secondary endpoint of overall survival favored the candidate drug. The primary efficacy study looked into two prospectively defined molecular sub-groups in a step-down manner: the BRCA group and all patients randomized in TRITON3, including those with ATM or BRCA mutations. Clovis plans to submit a supplemental new drug application to the FDA in the first quarter of 2023 for the subgroup of patients with mutations in BRCA. Later, the company intends to explore how Rubraca will perform when applied to the broader intent-to-treat population. An expanded description will be presented at the Prostate Cancer Foundation Annual Scientific Retreat in late October. Further data from the study will also be submitted to a medical meeting in early 2023. Heart Failure Drug Shows Promise For Type II Diabetes Sufferers The latest results from Lexicon Pharmaceuticals' SOLOIST-WHF Phase III trial of sotagliflozin for heart failure continued to show positive findings, as shown in its presentation at the Heart Failure Society of America's annual scientific meeting in 2022. In the poster titled "Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, Reduces First and Subsequent Heart Failure-related Events in Patients Admitted for Worsening Heart Failure," trial co-chair and University of Michigan School of Medicine professor Bertram Pitt, M.D., FACC said that patients who received sotagliflozin in the study experienced fewer single and multiple heart failure events compared to the those who were given a placebo. SOLOIST-WHF is evaluating the drug's efficacy when added to the standard of care of 1,222 participants with type II diabetes who had recently experienced being hospitalized for worsening heart failure. The study so far achieved the primary endpoint, which was the total number of events made up of deaths to CV causes, hospitalizations for HF and urgent visits for HF. Cytokinetics' Heart Failure Candidate Delivers Substantial Symptom Improvements Clinical trial participants who received Cytokinetics' drug candidate aficamten for heart failure experienced "substantial and significant symptom improvements" based on their Kansas City cardiomyopathy questionnaire (KCCQ) scores. Aficamten is an investigational selective, small molecule cardiac myosin inhibitor designed to reduce the number of active actin-myosin cross bridges during every cardiac cycle. It has the ability to suppress the myocardial hypercontractility linked with hypertrophic cardiomyopathy (HCM). The drug was also able to reduce contractility in preclinical models. Development efforts now look into its potential as a treatment that relieves symptoms, improves exercise capacity, and delivers long-term favorable effects. Aficamten has a breakthrough therapy designation from the FDA to treat symptomatic obstructive HCM. It is currently being evaluated in Cohort 4 of the REDWOOD-HCM Phase II clinical study for the said indication and in the SEQUOIA-HCM trial for the treatment of symptomatic obstructive HCM. Valbiotis Shares More Positive Data On Hypercholesterolemia Candidate Valbiotis' Phase II HEART trial of TOTUM•070 for hypercholesterolemia offered additional positive data from the commercially targeted group with cholesterol levels above 130 mg/dl. Three months into the study, those who received the drug saw a 13.7% reduction in blood LDL cholesterol levels and a 14.3% drop by the sixth month compared to the placebo group. Valbiotis believes that these favorable data, along with information confirming TOTUM•070's intestinal and hepatic mode of action, will support its commercialization plans by the first half of 2024. Before this most recent good news, the company shared its first positive results in June. The company will present these latest details at the following American Heart Association annual meeting.
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