Clinical Catch-Up: March 9-13


Although news of the COVID-19 pandemic has tended to dominate the news cycle, including for the biopharma industry, there were a number of clinical trial announcements last week. Here’s a look.

CytoDyn submitted an investigational new drug (IND) application to the FDA to conduct a Phase II trial with leronlimab for patients with respiratory complications related to COVID-19, the disease caused by the new coronavirus. Leronlimab is an investigational humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases and other diseases, including NASH. It met its primary endpoints in a Phase III trial in combination with standard antiretroviral therapies in HIV.

The company also announced that FDA recommended it request a preliminary Breakthrough Therapy designation meeting. CytoDyn also indicated that two patients receiving leronlimab, one for metastatic triple-negative breast cancer, and one with metastatic breast cancer, were showing continued positive progress.

Bristol Myers Squibb announced topline results from ELOQUENT-1, its Phase III trial of Emplicity (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd) compared to Revlimid and dexamethasone alone in newly diagnosed, previously untreated multiple myeloma patients who are not eligible for transplant. The addition of Emplicity did not show a statistically significant improvement in progression-free survival (PFS), the trial’s primary endpoints.

Acceleron Pharma announced that its Phase II clinical trial of ACE-083 in patients with Charcot-Marie-Tooth disease (CMT) failed to show functional improvement. The company indicated the drug did show a statistically significant increase in mean total muscle volume, which was the primary endpoint of the trial, but it didn’t lead to statistically significant improvements in function or quality of life secondary endpoints. Acceleron says it is discontinuing development of the drug.

Unum Therapeutics had a partial clinical hold placed on its Phase I trial for non-Hodgkin lymphoma over safety concerns. The trial is assessing ACTR707 in combination with Rituxan (rituximab) in patients with CD20+ B-cell non-Hodgkin’s lymphoma. One patient experienced a Grade 3 serious adverse event that is being evaluated as a possible new malignancy and may be related to ACTR707.

Albireo completed patient enrollment in its Phase II trial of elobixibat for nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD). Elobixibat is a first-in-class, once-daily, oral ileal bile acid transporter (IBAT) inhibitor. The company expects to report topline results in mid-2020.

Bellerophon Therapeutics completed its End-of-Phase II Meetings with the FDA for INOpulse for Pulmonary Hypertension associated with Pulmonary Fibrosis (PH-PF). They have finalized its planned pivotal Phase III trial using moderate to vigorous physical activity (MVPA) as the primary endpoint for approval.

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ViiV Healthcare presented positive 48-week data from a Phase III trial demonstrating every-two-month regimen for injectable rilpivirine and cabotegravir has similar efficacy to once-monthly dosing. The findings were from the ATLAS-2M Phase III trial. Cabotegravir is ViiV’s drug and rilpivirine is Janssen’s, a Johnson & Johnson company.

MedDay Pharmaceuticals announced its MED1003 failed to meet its primary and secondary endpoints in the second pivotal Phase III trial for progressive multiple sclerosis (MS). The trial, dubbed SPI2, evaluated the safety and efficacy of three daily doses of 100mg of MD1003 compared to placebo in 642 patients with progressive MS without recent relapses, which is also called not-active progressive MS. The primary endpoint was reversal of functional disability, which was measured by the proportion of patients with an improvement in either the Expanded Disability Status Scale (EDSS) or in how long it took patients to walk 25 feet (TW25) over a 12-month time frame and then confirmed at 15 months.

Secondary endpoints were the relative decrease in the risk of disability progression, global impression of response to the drug as evaluated by both the patient and their physician, and the mean change in TW25. Other exploratory endpoints included brain MRI measures, quality of life measures and measurements of ambulation using a Fitbit wearable device.

Gilead Sciences announced results from a Phase Ib clinical trial of its vesatolimod for HIV. Vesatolimod is an investigational toll-like receptor 7 (TLR7) agonist. The trial showed that TLR7 stimulation by vesatolimod was associated with a modestly increased time to viral rebound compared to placebo in addition to enhanced immune function and decreased levels of intact HIV DNA.

AstraZeneca and Merck announced that the Phase III GY004 trial of cediranib in combination with Lynparza compared to platinum-based chemotherapy in platinum-sensitive relapsed ovarian cancer failed to meet the primary endpoint. Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment focused against DNA damage response (DDR) pathway deficiencies, like those seen in BRCA mutations. Cediranib is an investigational oral vascular endothelial growth factor receptor (VEGFR) inhibitor that blocks blood vessel growth that helps tumors to grow. The primary endpoint was a statistically significant improvement in progression-free survival (PFS) for the combination versus platinum-based chemotherapy.

Pfizer and EMD Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, jointly announced that their Phase III JAVELIN Head and Neck 100 trial of Bavencio (avelumab) with chemoradiotherapy (CRT) for untreated locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) was unlikely to hit the primary endpoint. As such, they have shuttered that trial.

The study was evaluating Bavencio and CRT compared to standard-of-care CRT in the patient population. An independent Data Monitoring Committee (DMC) recommended the companies terminate the study because it was unlikely to show a statistically significant improvement in the primary endpoint, which was progression-free survival (PFS) based on a preplanned interim analysis.

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