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December 13, 2021updated 07 Jan 2022 6:47am

Regulatory roundup: Veru’s likelihood of further study in vasomotor symptoms jumps after Phase II completion

SAB Therapeutics in influenza A and Ocular Therapeutix in keratoconjunctivitis sicca is also reviewed by GlobalData’s Investigative News team.

By Adam Zamecnik

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 regulatory support; 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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Veru completes Phase II study

Veru’s VERU-944 saw its PTSR in vasomotor symptoms jump after the completion of a Phase II study. The PTSR grew by 15 points to 44%. VERU-944’s LoA in the same indication also increased by one point to 3% after the study’s completion.

The 93-subject, double-masked study (NCT03646162) had its status changed to “completed” in a 1 December update on ClinicalTrials.gov. GlobalData had its latest update on 2 December. The study saw a mean percentage of change in the frequency of moderate-to-severe hot flashes of -42.24% in subjects tested with 50mg. The study saw a percentage of change of -19.72% in those tested with 10mg of VERU-944 and a percentage of change of -46.59% in participants on placebo.

The study sought to examine the efficacy of VERU-944 in reducing the frequency of hot flashes in patients suffering from advanced prostate cancer. The hot flashes are a side effect associated with androgen deprivation therapy (ADT), a hormone therapy which is used in treating prostate cancer and slowing the growth of prostate cancer cells.

The study measured the change in frequency at a six-week timeframe as a primary outcome. Additionally, the trial also measured the change in severity of moderate-to-severe hot flashes as compared to the baseline at six weeks as one of its secondary outcomes. VERU-944 is an orally administered estrogen receptor agonist, which targets estrogen receptors.

SAB Therapeutics reports positive Phase IIa trial

SAB Therapeutics’ SAB-176 saw its PTSR in influenza A spike after the announcement of positive topline data from a Phase IIa study. The PTSR grew by 16 points to 65%. SAB-176’s LoA in influenza A increased by five points to 21% after the study’s completion.

The 62-subject, double-blinded study (NCT04850898) had its topline data published on 1 December. GlobalData updated its system on 3 December. The asset had seen a statistically significant reduction of the nasopharyngeal viral load in participants (p=0.026). The asset also saw a statistically significant reduction of clinical flu symptoms in subjects receiving active treatment versus placebo. SAB-176 met the secondary endpoint at day four with a p value of 0.013. The asset appeared to be well-tolerated.

The study sought to examine the safety and treatment efficacy of SAB-176 in healthy adult subjects administered the influenza A H1N1 virus. The participants had been either injected with a 25mg intravenous infusion of SAB-176 or with a saline solution placebo comparator. Examining the viral load of SAB-176 in comparison to the placebo comparator on a 28-day timeframe as a primary outcome, the study also evaluated the peak viral load on a 28-day timeframe as one of its secondary outcomes. SAB-176 is an intravenously administered polyclonal antibody, which can bind itself to type A and type B influenza viruses.

Ocular Therapeutix reports positive topline data

Ocular Therapeutix’s OTX-DED (dexamethasone intracanalicular insert) saw its PTSR in keratoconjunctivitis sicca bounce after the announcement of positive topline data from a Phase II study. The PTSR grew by 16 points to 58%. The asset’s LoA in dry eye disease grew by two points to 10%.

The 166-subject, double-masked study (NCT04747977) had its topline data published on 6 December. GlobalData updated its system on 8 December. The study had seen a statistically significant change of bulbar conjunctival hyperaemia from baseline to day 15 (p=0.004) for the 0.2mg dose of the asset, and a 0.028 p value for 0.3mg. Both doses appeared to be well tolerated.

The study sought to examine the asset’s efficacy and safety for the short-term treatment of symptoms affiliated with keratoconjunctivitis sicca, also known as dry eye disease. The participants had been treated with dexamethasone intracanalicular inserts or with a vehicle hydrogel insert as placebo comparator. The asset serves as a glucocorticoid agonist, which inhibits leukocyte infiltration at the site of inflammation.

BELLUS completes pruritus trial

BELLUS Health’s BLU-5937 for pruritus saw its PTSR get boosted by ten points to 41% after its Phase II trial was listed as completed. ClinicalTrials.gov updated the trial’s status from “ongoing” to “completed” on 1 December, and the PTSR change took effect the next day. The trial result also gave a four-point boost to the drug’s LoA, which now sits at 17%.

The Phase II BLUEPRINT trial (NCT04693195) enrolled 142 adults with chronic pruritus, commonly known as severe itch, who have atopic dermatitis. Prior to the recent ClinicalTrials.gov update, the study’s target enrollment was listed as 128 patients. As a primary endpoint, the placebo-controlled trial used Worst Itch Numeric Rating Scale (WI-NRS), a single-item, patient-reported questionnaire assessing itch severity on a scale of 1 to 10. BLU-5937 is a benzoimidazole derivative in development to treat severe itching.

Livalo and ezetimibe study in hypercholesteremia completes

JW Pharmaceutical’s combination therapy of ezetimibe and Livalo (pitavastatin) for primary hypercholesterolemia saw its LoA jump nine points to 49% following a Phase III trial completion. The combination trial’s status was updated from “ongoing” to “completed” on ClinicalTrials.gov on 1 December, and the LoA change took effect the next day. JW Pharmaceutical is currently marketing the ezetimibe and Livalo combination as Livalozet in to treat dyslipidaemia in South Korea.

The 283-patient Phase III trial (NCT04584736) tested the combination of ezetimibe and Livalo against the Livalo monotherapy. As a primary endpoint, the study measured percentage change in low-density lipoprotein cholesterol (LDL-C) levels after eight weeks. The multi-center trial took place in South Korea, according to ClinicalTrials.gov. Ezetimibe can lower cholesterol, and Livalo is cardioprotective and can control rising blood glucose levels.

Arch Biopartners reveal positive Phase II results

Arch Biopartners’ LSALT Peptide (LSALT and Metablok) for acute respiratory distress syndrome (ARDS) and acute renal failure (ARF) saw its PTSR in COVID-19 soar after positive Phase II data. The PTSR rose 16 points to 56% in ARDS and 16 points to 47% in ARF.

The Phase II study (NCT04402957), which enrolled 61 patients with COVID-19 infection, tested the therapy’s efficacy in preventing the development of ARDS and other acute organ injuries as the primary endpoint. The study was exploratory and thus not powered for statistical significance, a 1 December press release stated. Other endpoints looked at critical care requirements, with the study finding patients on the LSALT Peptide group had 22.8 ventilation-free days compared to 20.9 ventilation-free days in the placebo cohort.

LSALT Peptide will now be evaluated in a 320-patient arm of the Canadian portion of the Phase II CATCO trial (NCT04330690). CATCO is a global, adaptive-design study of COVID-19 treatments sponsored by the Sunnybrook Research Institute (SRI) and the World Health Organization (WHO). LSALT peptide inhibits leukocyte adhesion to dipeptidase-1 enzyme (DPEP-1) present in lungs, kidney, and liver and is considered to have anti-inflammatory effects in COVID-19.

The completed trial also resulted in a modest 3-point bump to the drug’s LoA in ARDS, which now sits at 11%. In ARF, the LoA remains at 1%.

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