AstraZeneca announces encouraging results from OSTRO trial

AstraZeneca (AZN) reported positive data from its Phase III OSTRO trial pertaining Fasenra. The study met both its co-primary endpoints in patients with chronic rhinosinusitis with nasal polyps. The safety profile and tolerability of the drug candidate in this trial were in line with the known profile of the medicine.

OSTRO is a randomised, double-blinded, multi-centre, parallel-group, 56-week Phase III trial. It assessed the efficacy and safety of Fasenra compared to placebo in patients with nasal polyposis. The trial involved participants, regardless of blood eosinophil count with or without asthma, who were symptomatic despite SoC therapy, including current use of INCS and prior surgery and/or use of systemic corticosteroids. Patients were randomized to be administered either Fasenra 30mg or placebo. These were given subcutaneously every four weeks for the first three doses followed by every eight weeks thereafter.

The primary endpoint of the trial was the impact of the drug candidate on nasal polyp burden. This metric was measured by determining change from baseline in endoscopic total NPS, at week 40 compared to placebo. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said, “Patients with chronic rhinosinusitis with nasal polyps suffer significantly with nasal congestion and a reduced quality of life. Current treatments, such as intranasal or oral corticosteroids and surgery to remove polyps, do not fully address patient needs.” NPS was evaluated through a physician assessment of polyp size during endoscopy.

The impact of Fasenra on patient-reported nasal blockage, assessed by change from baseline in mean NBS, at week 40 compared to placebo. The trial involved 413 participants spread across North America and Europe. Currently, nasal polyps are treated through intranasal or oral corticosteroids and surgery. However, these regimens do not address the underlying causes.

Fasenra (benralizumab) is a monoclonal antibody and it works by binding directly to IL-5 receptor alpha on eosinophils. It prompts rapid and near-complete diminution eosinophils through apoptosis. The drug candidate is also being evaluated for treating eosinophilic diseases and chronic obstructive pulmonary disease. It was granted Orphan Drug Designation for treating eosinophilic granulomatosis with polyangiitis in 2018. Fasenra was given the same title for hypereosinophilic syndrome and eosinophilic oesophagitis in 2019. Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc.

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OSTRO is part of AstraZeneca’s clinical trial programme for Fasenra in CRSwNP. The program also incorporates the current Phase III ORCHID trial, among others. Chronic rhinosinusitis with nasal polyps causes persistent inflammation of the mucous membrane lining the nasal passages and sinuses. It also leads to growth of nasal polyps, which are generally benign. The ailment may cause decline in the sense of smell, breathing problems and nasal discharge.

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries. It is also approved for self-administration in the United States, EU and various other countries. The OSTRO data demonstrated that the drug candidate may benefit the patients through its eosinophil-depleting mechanism.

Forte Biosciences reports positive data for FB-401

Forte Biosciences Inc. (FBRX) announced the full data from its Phase 1/2a trial of FB-401, its lead drug candidate. The study evaluated the drug candidate for treating atopic dermatitis. It involved 20 patients with mild, moderate and severe condition. The age range for the participants was from 3 to 16 years of age.

In the pediatric cohort of the study, the patients were treated topically with FB-401 for 16 weeks. The drug candidate was administered twice weekly for 12 weeks and then every other day for the final 4 weeks. 90 percent of the pediatric patients reported at least a 50% improvement in the Eczema Activity and Severity Index. All the patients with moderate to severe condition achieved EASI-50. The data showed 77 percent mean improvement in the EASI score. Further, improvements were observed on all actively treated body sites.

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The data also showed improvement in Pruritus or itch by an average of 58 percent. Paul Wagner, Ph.D. CEO of Forte, said, “The publication of the clinical and mechanistic data in Science Translational Medicine highlights the significant potential of FB-401, particularly for pediatrics, who account for a significant fraction of AD patients and for whom safe and effective treatment options are limited.” The company plans to start a randomized placebo-controlled trial of the drug candidate in AD patients 2 years of age and older.

FB-401 is a live biotherapeutic and consists of precisely chosen strains of commensal, Roseomonas mucosa. It has been evaluated in an open-label Phase 1/2a trial in atopic dermatitis patients. The drug candidate showed robust tolerability and substantial improvement in disease activity in both adults and children. It works by impacting pathways which deal with tissue repair and inflammation. It is the lead drug candidate for Forte, which plans to start Phase 2 trial in the third quarter of 2020.

Takeda suffers setback for its Phase 3 multiple myeloma trial

Takeda Pharmaceutical Company Limited (TAK) announced its Phase 3 TOURMALINE-MM2 trial data. The study analyzed the addition of NINLARO (ixazomib) to lenalidomide and dexamethasone versus lenalidomide and dexamethasone plus placebo in newly diagnosed multiple myeloma patients. These patients are not eligible for autologous stem cell transplant.

The data demonstrated that the addition led to a 13.5-month increase in median progression-free survival to 35.3 months in the NINLARO arm. Placebo arm reported 21.8 months for this metric. The trial did not meet the threshold for statistical significance and failed to achieve its primary endpoint of PFS.

The other endpoints for the trial were complete response (CR) rate, overall survival (OS) and median time to progression (TTP). Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda, said, “We hope the findings from the TOURMALINE-MM2 trial will encourage constructive conversations and help progress future research efforts, particularly for patients who could benefit from an all-oral, proteasome inhibitor-based combination that helps preserve quality of life.” The safety profile was largely in line with the existing prescribing information.

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The median follow-up of 57.8 months in the NINLARO arm versus 58.6 months in the placebo arm for OS was undertaken. However, neither arm reached the median OS. NINLARO combination showed median TTP of 45.8 months, while placebo arm reported 26.8 months. 96.6 percent patients in treatment arm experienced treatment emergent adverse events while 92.6 percent patients in placebo cohort reported the same.

NINLARO is currently approved in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. However, it is not approved of treating newly diagnosed multiple myeloma. TOURMALINE-MM2 involved 705 adult patients with newly diagnosed multiple myeloma who are not candidates for transplant.

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