In an Interview with PharmaShots, Nathalie Landry, Executive Vice President, Scientific, and Medical Affairs at Medicago share her views on the P-II results of adjuvanted plant-based COVID-19 vaccine. Shots: The P-II study involves assessing the safety & immunogenicity of the CoVLP vs PBO in 306 subjects aged ≥18yrs. with two age groups (18-64yrs & over […]Read More
Shots: The company reported the results from a study based on the structural and functional analysis of SB11, a proposed biosimilar referencing Lucentis (ranibizumab) The analytical assessment demonstrated that structural, physicochemical characterization i.e. amino acid sequence, post-translational modifications, higher order structure, and size and charge variants of SB11 were similar to Lucentis The SB11 is […]Read More
Shots: The P-III MELODY study involves evaluating Nirsevimab (50mg/100mg, IM) vs PBO to determine the incidence of medically attended LRTI due to RSV confirmed by RT-PCR testing through 150days after dosing in healthy infants in a ratio (2:1) entering their first RSV season The study met its 1EPs i.e. reduction of LRTI due to RSV […]Read More
Shots: The two P-III PSOARING 1 and PSOARING 2 trials involve evaluating Tapinarof (1% dosed, qd) vs vehicle (qd) in 1,025 patients aged 18-75yrs. with plaque psoriasis Results: 2EPs & PRO, @12wks., PASI90 (18.8% and 20.9%) vs (1.6% and 2.5%), ≥4-point NRS improvement (67.5% and 59.7%) vs (46.1 and 31.3%), improvement in QoL as measured […]Read More
Shots: The two P-III POETYK PSO-1 and POETYK PSO-2 trials evaluating deucravacitinib (6mg, qd) vs PBO & Otezla (30mg, bid) @16wks. and vs Otezla @24wks. in 666 and 1,020 patients with the mod. to sev. plaque psoriasis respectively The trials met its co-1EPs & 2EPs i.e @16wks., PASI 75 (58.7% and 53.6%) vs (12.7% and […]Read More
Shots: The P-III ENSEMBLE trial involves assessing COVID-19 vaccine vs PBO in 43,783 enrolled participants aged ≥18yrs. with both mod. and sev. COVID-19 disease The trial met all 1EP & 2EPs i.e 85% efficacy in preventing disease, vaccine efficacy was consistent against symptomatic infection including in South Africa and Brazil that showed a high prevalence […]Read More
Shots: The P-III withdrawal study involves assessing the efficacy and safety of Xywav (oral solution) vs PBO in a ratio (1:1) in adult patients with idiopathic hypersomnia. The study includes a titration and optimization period of up to 14wks. followed by a 2wks. open-label, SDP The study demonstrated a change in ESS score within 2wks., […]Read More
Shots: The second P-III BRAVE-AA1 trial involves assesing the efficacy and safety of Baricitinib (2mg/4mg, qd) vs PBO in adults with a SALT score ≥ of 50 (i.e., who had ≥50% scalp hair loss) in addition to current episode of severe AA lasting at least 6mos. but no >8yrs. The P-III study met its 1EPs […]Read More
Shots: The P-IIb POC Study 201 involves assessing lecanemab in patients with early AD Results: @18mos, prespecified analysis showed a consistent reduction of clinical decline across several clinical and biomarker EPs at highest doses and reduction in brain Aβ & clinical decline. The results are published in a peer-reviewed journal In March, the companies have […]Read More
Shots: The P-III HELIOS-A study assessing Vutrisiran (25mg, SC, once every 3mos.) vs patisiran (0.3 mg/kg, IV, q3w) in 164 patients in a ratio (3:1) with hATTR amyloidosis with polyneuropathy The study met its 1EPs & 2EPs i.e. change from baseline in mNIS+7 @9mos. & improvement in QoL assessed by Norfolk QoL-DN and gait speed […]Read More
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