Shots: The BTD is based on the P-II TRAILBLAZER-ALZ trial assessing donanemab vs PBO in 272 patients with early symptomatic AD who were selected based on cognitive assessments in conjunction with amyloid plaque imaging & tau staging by PET imaging The 1EP & 2EP of study @76wks. is the change from baseline in iADRS, ADAS-Cog13 […]Read More
Shots: The FDA’s BT designation is based on results from P-IIb Study 201 trial evaluates lecanemab in 856 patients with MCI due to AD and mild AD with confirmed presence of amyloid pathology The pre-specified analysis showed a consistent reduction of clinical decline across several clinical & biomarker EPs at highest dose while OLE data […]Read More
Shots: The approval is based on the two P-III clinical trials i.e EMERGE and ENGAGE along with P-Ib PRIME study involves assessing the efficacy of Aduhelm vs PBO in patients with early stages of AD with confirmed presence of amyloid pathology Results: the therapy consistently showed a dose and time-dependent effect on the reduction of […]Read More
Shots: The company has completed the enrollment in the P-IIB HOPE4MCI trial evaluating the efficacy of AGB101 vs PBO in 164 patients to treat amnestic mild cognitive impairment due to AD across 23 sites in the US and Canada The HOPE4MCI study followed an earlier study that showed a reduction in hippocampal overactivity and improvement […]Read More
Shots: The US FDA has granted FT Designation to LX1001 for the treatment of APOE4 associated AD. The designation evaluates to facilitate the development and expedite the review of drug The company has initiated P-I trial to assess the safety and toxicity of LX1001 as a potential one-time treatment for early-stage AD patients with mild […]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: Novo Nordisk plans to initiate a pivotal P-llla program to evaluate the efficacy and safety of Semaglutide (oral, 14mg, qd) vs PBO in 3,700 patients with AD with the anticipated initiation in H1’21 The decision follows the evaluation of GLP-1 data from preclinical models, real-world evidence studies, post-hoc analysis of data from large cardiovascular […]Read More
Shots: The submission is based on P-lll EMERGE and ENGAGE study assessing aducanumab vs PBO in patients with AD. The studies evaluate the efficacy of monthly doses of aducanumab in reducing cognitive and functional impairment The secondary objectives of the study were to assess the effect of monthly doses of aducanumab on the clinical decline […]Read More
Shots: NeuroLucent will receive an upfront along with additional payments upon the achievement of milestones. The companies collaborated to accelerate search for a therapeutic candidate PostEra will use its ML technology to optimize NeuroLucent’s lead compounds through a series of design make test cycles that has previously been shown to accelerate medicinal chemistry campaigns PostEra […]Read More
Shots: AC Immune to receive $80M upfront, $1760M milestones and royalties on sales and Lilly to get WW commercialization rights for AC Immune’s tau aggregation inhibitors and will invest $50M as convertible notes in AC. AC to initiate P-I study for Morphomer inhibitors and Lilly to fund the trial The focus of the agreement is to develop AC Immune’s […]Read More
Copyright ©2021 PharmaShots | Powered by Octavus Consulting
