Clinical Catch-up for July 22-26

clinical roundup pills

A number of companies reported clinical trial data last week. Here’s a look.

Takeda Pharmaceutical’s VISIBLE 2 Phase III clinical trial in Crohn’s disease hit its primary endpoints. The trial evaluated Entyvio (vedolizumab) as a maintenance therapy in moderately or severely active Crohn’s disease. The primary endpoint was statistically significant percentage of patients who achieved clinical remission at 52 weeks compared to placebo. The company reported results on its VISIBLE 1 trial in May, where a subcutaneous version of Entyvio created a 46.2% clinical remission rate in ulcerative colitis patients at week 52, compared to 14.3% in patients receiving placebo.

Intec Pharma announced top-line data from its Phase III trial, ACCORDANCE, of its Accordion Pill, carbidopa/levodopa (AP-CD/LD) compared with immediate release CD/LD (IR-CD/LD), Sinemet) for symptoms of advanced Parkinson’s disease. The trial did not show statistical superiority to Sinemet on the primary endpoint of reduction in daily OFF time. Intec noted that in some subsets of patients the treatment was very effective, so they plan to continue to analyze the full data set as they move forward.

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HAMLET Pharma reported that Alpha1H in bladder cancer was successful in the Phase I/II clinical trial. Alpha1H triggered significant shedding of cells in all cancer patients who received the treatment. The compound, Human Alpha-lactalbumin Made Lethal (HAMLET) also triggered the excretion of whole tumor fragments into the urine. The trial evaluated 40 patients, 20 receiving placebo and 20 who received six transfusions of Alpha1H over 22 days.

Resolve Therapeutics announced it had completed enrollment in its Phase IIa trial of RSLV-132 for Systemic Lupus Erythematosis (SLE). It is a double-blind, placebo-controlled trial in 64 lupus patients in 20 centers in the U.S. It is looking to determine the efficacy and safety of RSLV-132 compared to placebo. RSLV-132 is a novel, targeted biologic designed to remove pro-inflammatory nucleic acids from patients’ circulation.

ViiV Healthcare, the HIV-focused joint venture of GlaxoSmithKline, Pfizer and Shinogi Ltd., reported that its Phase III BRIGHTE trial hits its 96-week endpoints in heavily treatment-experienced adults with HIV-1 infection. The trial analyzed fostemsavir, a first-in-class attachment inhibitor, in combination with optimized background treatment (OBT) in this population. At 92 weeks, 60% of the fostemsavir plus OBT cohort achieved virologic suppression, a 6% increase over the 48-week result. Also at 96 weeks, the patients on fostemsavir showed an increase in CD4+ T-cell counts, a mean change from baseline of +205 cells per microliter.

ACADIA Pharmaceuticals announced top-line results from its Phase III ENHANCE clinical trial of Parkinson’s drug Nuplazid (pimavanserin), which though it showed improvement in schizophrenia treatment, failed to hit statistical significance for its primary endpoint.

In the trial, 396 patients moderate-to-severe psychotic symptoms related to adult schizophrenia received either Nuplazid or placebo added to their current antipsychotic treatment. The patients receiving Nuplazid showed a consistent trend in symptom improvement but did not hit statistical significance on the primary endpoint, which was the Positive and Negative Syndrome Scale (PANSS) total score. The company also indicates that there was a positive trend on a key secondary endpoint, the Clinical Global Impression-Severity (CGI-S) score.

Actinium Pharmaceuticals announced that the 75th patients had been treated in its Phase III SEIRRA trial of lomab-B for elderly relapsed/refractory acute myeloid leukemia. This is the midpoint of the trial. Lomab-B is an antibody radiation-conjugate (ARC) made up of the anti-CD45 antibody apamistamab and the radioisotope I-131. To date the trial has shown promising preliminary feasibility and safety data.

resTORbio completed patient enrollment of its Phase III PROTECTOR 1 trial ahead of its clinical timeline. It has 1,024 patients. It is the first of two global Phase III trials looking at RTB101 to improve the immune function of patients aged 65 or older to decrease the incidence of respiratory tract infections (RTIs). RTB101 is an oral, selective, and potent TORC1 inhibitor.

Chiasma reported top-line results from its Phase III CHIASMA OPTIMAL clinical trial. The trial is evaluating octreotide capsules for the maintenance treatment of adults with acromegaly. The trial met primary and all secondary endpoints with no new or unexpected safety signals. In the trial, 58% of patients on octreotide capsules maintained their IGF-1 response compared to 19% of patients on placebo.

SCYNEXIS announced it had reached an agreement with the FDA under a Special Protocol Assessment (SPA) on the design, trial population, endpoints and statistical analysis of its Phase III CANDLE clinical trial. The trial will evaluate oral ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (VVC), otherwise known as a vaginal yeast infection. The primary endpoint is efficacy measured by the percentage of patients with no recurrences of VVC up through an evaluation at week 24.

Arena Pharmaceuticals dosed its first patient in the Phase II CAPTIVATE trial of olorinab for visceral pain associated with gastrointestinal disorders. The trial is studying the efficacy and safety of three doses of olorinab for 12 weeks in about 240 patients experiencing abdominal pain associated with irritable bowel syndrome (IBS), including IBS with constipation (IBS-C) or IBS with diarrhea (IBS-D).

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Innovent Biologics dosed its first patient in its ORIENT-31 trial to evaluate Tyvyt (sintilimab injection) co-developed with Eli Lilly and Company, and IBI305, in combination with chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer (NSCLC) who have progressed from prior treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). The Phase III trial is being conducted in China to evaluate the safety and efficacy of Tyvyt and IBI305 with chemotherapy in this patient population. 480 patients will be enrolled in the trial.

Janssen Pharmaceutical, a Johnson & Johnson company’s Phase III OPTIMUM clinical trial of its ponesimod met its primary and most secondary endpoints for relapsing’s forms of multiple sclerosis. The drug, a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, was compared in a head-to-head trial to Sanofi’s Aubagio (teriflunomide) in adults with relapsing MS. The primary endpoint was annualized relapse rate (ARR) up to the end of the study, with a key secondary endpoint the change from baseline to week 108 in fatigue-related symptoms.

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