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November 29, 2021

Regulatory roundup: Invokana approval shot increases in heart failure with positive Phase III data

Merck KGaA in schistosomiasis and Jupiter Wellness in first-degree burns are also reviewed by GlobalData’s Investigative News team.

By Reynald Castañeda

Need to know:

GlobalData’s Investigative News team reviews data generated by an in-house model that combines machine learning and its proprietary algorithm. Likelihood of Approval (LoA) provides the probability of a drug in securing market authorization; Phase Transition Success Rate (PTSR) indicates the probability of a drug advancing to the next stage of development. The model uses data points from individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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J&J reports positive Invokana trial

Johnson & Johnson’s Invokana (canagliflozin) saw its LoA spike in heart failure after positive Phase III study results were revealed. The LoA grew by 16 points to 57% in systolic heart failure and by 8 points to 33% in diastolic heart failure.

The Phase III Invokana study (NCT04252287) had its results unveiled on 14 November at this year’s American Heart Association Scientific Sessions. GlobalData appraised the drug on 18 November.

The 476-subject Phase III CHIEF-HF trial had a primary endpoint of change from baseline in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS). At 12 weeks, there was an improvement with Invokana, with a mean difference of over 4.3 points versus placebo.

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Invokana is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It already has FDA approval in type 2 diabetes, specifically in lowering blood sugar in adult patients, reducing the risk of major cardiovascular events, and reducing the risk of end-stage kidney disease.

Merck reports positive Phase III schistosomiasis data

Merck KGaA’s L-PZQ (levo-praziquantel) saw its LoA jump in schistosomiasis after positive Phase III study results were revealed. The LoA grew by 10 points to 24% in the indication.

The Phase III study (NCT03845140) had its results announced in a 16 November official press release shared by the company. GlobalData appraised the drug on 18 November. The asset had seen a cure rate close to or above 90% in subjects suffering from schistosomiasis, a disease caused by parasitic flatworms known as schistosomes. The asset specifically targeted Schistosoma mansoni and S. haematobium, two species which often induce the indication.

The 311-subject, open-label Phase III trial sought to examine the efficacy and safety of levo-praziquantel, also known as arpraziquantel, in children between the age of three months and six years having schistosomiasis infection. Levo-praziquantel is administered orally and induces a rapid contraction in the schistosomes, causing vacuolization and subsequently killing the parasites.

The study had a primary endpoint of the number of participants without any sign of parasite eggs in subject stool or urine on a 17-to-21-day timeframe after the initial treatment with a single dose of levo-praziquantel. The study also measured the egg reduction rate before treatment and 17-to-21 days post-treatment.

Jupiter Wellness likely to move ahead in burns

Jupiter Wellness’s JW-300 saw its PTSR jump by 12 points to 66% in treating first-degree burns after the company reported positive trial data. The announcement was made on 16 November, and the topical cream’s PTSR was updated on 18 November. JW-300 is a cannabidiol and aspartame combination.

The double blinded placebo-controlled trial recruited 36 participants. A controlled area of the skin that was exposed to UV irradiation was treated with placebo or the JW-300 cream. Data shows that the average erythema score in 18 people on the JW-300 arm was 0.388 after radiation versus 0.722 among 18 placebo arm volunteers. Further, 61% of placebo arm subjects were burned compared with 27% with JW-300.  While these results bolstered JW-300’s PTSR, its LoA remained at 3%.

Phase I trial of Ziopharm asset completed

A University of Texas-sponsored Phase I study of Ziopharm Oncology’s CD19-specific CAR-T cell asset saw its PTSR climb following the announcement of the study’s completion. The PTSR grew by 29 points to 75% in chronic lymphocytic leukemia (CLL) and by six points to 65% in acute myelocytic leukemia (AML).

The 26-subject Phase I study (NCT02529813) had its status changed to “completed” as per a 16 November on ClinicalTrials.gov. GlobalData had its latest update on 18 November. Subjects were treated with CD-19 specific CAR-T cells in combination with Cytoxan (cyclophosphamide) and Fludara (fludarabine phosphate). CD-19 specific CAR T-cells target CD-19, a transmembrane protein which appears on cancers linked to B cells. This includes AML and CLL.

The trial sought to investigate the side effects and best dosage of CD-19 specific CAR T-cells in patients suffering from lymphoid malignancies, including indications such as AML and CLL. The study examined the maximum tolerated dose of CD-19 specified T-cells in an up to 30-day timeframe as the primary outcome. The trial also investigated the proportion of patients experience a response, complete or partial, in a one-year timeframe as one of its secondary outcomes. The asset’s LoA also grew. The LoA rose by three points to 5% in CLL and by 1 point to 4% in AML.

Connect Biopharma reports positive eczema data

Connect Biopharmaceuticals’ CBP-201 saw its LoA for atopic dermatitis leap 12-points to 29% following positive Phase II data. The company released topline results in an 18 November press release, and the LoA change took effect the next day. The Suzhou, China-based biotech has already announced its plans to initiate a Phase III trial of CBP-201 in mid-2022.

In the 226-patient Phase II trial (NCT04444752), CBP-201 met its primary endpoint of percentage reduction in the Eczema Area and Severity Index (EASI) score from baseline to week 16. EASI is a validated scoring system that measures physical symptoms and signs of atopic dermatitis, which is the most diagnosed chronic inflammatory skin disorder. Reported treatment-emergent adverse events (AEs) and serious AEs were similar between CBP-201 treatment groups and placebo. Connect Biopharma plans to discuss full detailed results from the trial by January 2022 once additional analyses are complete.

CBP-201 targets interleukin-4 receptor alpha (IL-4Rα), which is implicated in inflammatory diseases. In the trial, the antibody was subcutaneously administered to adults with moderate to severe atopic dermatitis.

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