Although it was a relatively slow week for clinical trial updates, there were still a number of announcements. Here’s a look.
Although it was a relatively slow week for clinical trial updates, there were still a number of announcements. Here’s a look.
United Therapeutics announced that its Phase II/III DISTINCT trial failed to meet its primary efficacy endpoint. The trial was evaluating Unituxin (dinutuximab) with irinotecan compared to irinotecan or topotecan alone in relapsed or refractory small cell lung cancer (SCLC). The primary efficacy objective was extending the overall survival with Unituxin and irinotecan compared to the control group of irinotecan alone. Unituxin is a GD2-binding monoclonal antibody.
Insmed announced positive topline data from its Phase II WILLOW trial of INS1007 in non-cystic fibrosis bronchiectasis (NCFBE). INS1007 is a novel, oral, selective, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). The trial met its primary endpoint of time to first pulmonary exacerbation over the 24-week treatment period for both doses compared to placebo. It also decreased the frequency of pulmonary exacerbations.
Eli Lilly and Incyte announced that Olumiant (baricitinib) met the primary endpoint in the BREEZE-AD5 Phase III trial. It was evaluating baricitinib in adults with moderate to severe atopic dermatitis. The primary endpoint was the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16. Olumiant is approved for adults with moderately to severely active rheumatoid arthritis (RA) in more than 60 countries.
Zai Lab dosed the first patients in two separate clinical trials. The first is a Phase Ib dose-escalation and expansion trial of niraparib in combination with MGD013 for advanced or metastatic gastric adenocarcinoma or gastroesophageal junction acenocardinoma patients who failed previous treatment. The second is a registrational bridging trial of margetuximab in combination with chemotherapy for metastatic HER2-positive breast cancer.
Alkahest dosed the first patient in a Phase II trial of AKST4290 for Parkinson’s disease. It is funded in part by The Michael J. Fox Foundation for Parkinson’s Research (MJFF). AKST4290 is an oral CCR3 inhibitor that blocks the action of eotaxin, an immunomodulatory protein that increases as people age and with specific age-related diseases.
The National Institute of Allergy & Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), halted administration of its vaccinations in its HVTN 702 trial of an investigational HIV vaccine. An independent data and safety monitoring board (DSMB) found it didn’t prevent HIV. There were no safety issues. The trial, a Phase IIb/III study, began in 2016 in South Africa.
Menlo Therapeutics published the data from its Phase II trial of serlopitant for pruritus (itching) associated with psoriasis. The drug significantly reduced pruritus in the patients and was well-tolerated, hitting its primary endpoint. Serlopitant is a once-daily oral NK1 receptor antagonist.
CytoDyn filed a Phase II protocol for a basket trial with the FDA under its cancer IND. The company can now immediately initiate enrollment in the Phase II trial for about 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon, breast, testicular, ovarian, uterine, pancreas, bladder and others. It will evaluate leronlimab, the company’s CCR5 antagonist. It will continue to enroll patients in its metastatic breast cancer trials.
The University of Texas MD Anderson Cancer Center published positive results from a Phase I/IIa trial of cord blood-derived CAR NK cell therapy targeting CD19. The therapy showed clinical responses in 73% of patients with r/r non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
Kodiak Sciences presented additional clinical data on KSI-301 for three retinal diseases, wet AMD, Diabetic Macular Edema and Retinal Vein Occlusion. The company indicated it plans to initiate four more pivotal clinical trials of the drug with hopes of filing an initial BLA in 2022. KSI-301 is an anti-VEGF therapy.
Roche presented one-year data from Part 2 of its SUNFISH trial of risdiplam in people aged 2-25 years with Type 2 or 3 spinal muscular atrophy (SMA). The study showed a change from baseline in the primary endpoint of the Motor Function Measure Scale (MFM-32) was significantly greater in the risdiplam cohort compared to placebo. Risdiplam is a survival motor neuron-2 (SMN2) splicing modifier for SMA.
Keck School of Medicine at USC is launching a clinical trial to determine if a manmade antibody will slow or stop Alzheimer’s disease. The AHEAD 3-45 Study will study BAN2401, which is designed to bind to beta-amyloid. The trial will be led by Paul Aisen, director of USC’s Alzheimer’s Therapeutic Research Institute in San Diego and Reisa Sperling and Keith Johnson from Brigham and Women’s Hospital and Massachusetts General Hospital in partnership with Eisai.
Foamix Pharmaceuticals published data from its Phase III studies FX2016-11 and FX2016-12 of FMX103 (minocycline) for moderate to severe papulopustular rosacea in adults. Both trials showed high statistically significant superiority compared to placebo in absolute inflammatory lesion reduction and Investigator’s Global Assessment (IGA) at Week 12.
Zogenix reported positive topline data from its Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome (LGS). LGS is a severe childhood-onset form of epilepsy. The trial met the primary objective showing the drug was superior to placebo in decreasing the frequency of drop seizures.
Aduro Biotech initiated a Phase II trial of MK-5890, an anti-CD27 agonist, in non-small cell lung cancer (NSCLC). The launch triggered a $10 million milestone payment from Merck. The trial will assess the efficacy and safety of Merck’s checkpoint inhibitor Keytruda (pembrolizumab) in combination with MK-5890 in advanced squamous or non-squamous NSCLC that have been previously treated with an anti-PD-L1 checkpoint inhibitor.
Catalyst Biosciences announced positive data from its Phase IIb trial of DalcA in hemophilia B. DalcA is a next-generation subcutaneously administered Factor IX (FIX) therapy. The data showed that 28 days of DalcA provided protective target FIX levels of more than 12%, with steady state FIX levels of up to 27% after 14 days with no bleeds.
