Alpha Cognition Announces Positive Neuroprotection Data from Pre-Clinical Study of ALPHA-1062 for Traumatic Brain Injury

Alpha Cognition Inc. | February 23, 2022

Alpha Cognition Inc. a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, is pleased to announce histology data from their intranasal ALPHA-1062 Traumatic Brain Injury (TBI) program. ALPHA-1062 treatment was neuroprotective, preserving hippocampal structure, reducing cell loss and promoting neurogenesis compared to no treatment. Functional recovery data released in December demonstrated statistically significant improvement in motor, sensory and cognitive functioning in all measures. Today’s histological results, combined with positive functional data released previously, strongly support the further development of ALPHA-1062 for the treatment of TBI.

These data, together with the data released previously, demonstrate that ALPHA-1062 exhibits both neuroprotection and enhances restoration of sensory, motor, and cognitive performance in this model of moderate traumatic brain injury. We are very encouraged by the preclinical data which gives us confidence in the potential of ALPHA-1062 to become an effective treatment for TBI. We plan to meet with the FDA to discuss our clinical development plan in the coming months.”

Denis Kay, the Company’s Chief Scientific Officer 

In a rodent model of TBI, ALPHA-1062 or vehicle was administered intranasally, with treatment initiated 2 hours after injury and continued twice daily for 35 days. A sham cohort of animals was also used for comparison.

Compared to vehicle treatment, ALPHA-1062

  • Demonstrated statistically significant reduction in lesion size measured at 35 days after injury.
  • Preserved greater hippocampal structure. The hippocampus plays a critical role in learning, memory formation, and spatial coding and damage to hippocampus can lead to memory disorders like AD, amnesia, and depression.
  • Demonstrated statistically, significant reduction in neuronal cell loss. The number of neurons in the ALPHA-1062 treated animals were equivalent to those in the uninjured cohort of animals at the end of treatment.

Statistically significantly enhanced neurogenesis as evidence by an increase in the number of neuron precursor cells and new neurons in the dentate gyrus, which plays a critical role in learning, information processing, and mood regulation.
Lauren D’Angelo, the Company’s Chief Commercial Officer, commented: “Traumatic brain injury is a highly prevalent and increasingly common condition, with nearly 3 million diagnosed events in the United States in 2019, with no FDA approved treatment. There is a significant unmet need for effective therapies to help patients who suffer a traumatic brain injury, and we are encouraged by the commercial opportunity for ALPHA-1062 in this indication.”

About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Amyotrophic Lateral Sclerosis (ALS), for which there are limited treatment options.

ALPHA-1062 is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ALPHA-1062's active metabolites are differentiated from donepezil and rivastigmine in that they bind neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia and as an intranasal formulation for traumatic brain injury.


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Alnylam Announces 3-Month Extension of Review Period for New Drug Application for Vutrisiran

Alnylam Pharmaceuticals, Inc. | April 05, 2022

Alnylam Pharmaceuticals, Inc. the leading RNAi therapeutics company, announced that the U.S. Food and Drug Administration has extended the review timeline of the New Drug Application for vutrisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated amyloidosis, to allow for the review of newly added information related to the new secondary packaging and labeling facility. Alnylam recently learned that the original third-party secondary packaging and labeling facility the Company planned to use for the vutrisiran launch was recently inspected and the inspection requires classification for the FDA to take action on the vutrisiran NDA. The inspection observations were not directly related to vutrisiran. In order to minimize delays to approval, Alnylam has identified a new facility to pack and label vutrisiran and submitted an amendment to the NDA for review by the FDA. The updated Prescription Drug User Fee Act goal date to allow for this review is July 14, 2022. No additional clinical data have been requested by the FDA. “We are committed to working with the FDA and the new facility to bring this important treatment option as quickly as possible to patients living with the polyneuropathy of hATTR amyloidosis, an inherited, progressively debilitating, and fatal disease. We are confident in our regulatory application and the body of data supporting the efficacy and safety of vutrisiran.” Pushkal Garg, M.D., Chief Medical Officer & EVP, Development and Medical Affairs Vutrisiran is also under review by the European Medicines Agency the Brazilian Health Regulatory Agency and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). We aim to minimize the impact of this issue on these reviews through timely resolution of the matter or utilization of an alternative facility for one or more of these regions. Vutrisiran has been granted Orphan Drug Designation in the U.S. and the European Union (EU) for the treatment of ATTR amyloidosis, and in Japan for transthyretin type familial amyloidosis with polyneuropathy. About Vutrisiran Vutrisiran is an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis, which encompasses both hATTR and wild-type ATTR amyloidosis. It is designed to target and silence specific messenger RNA, potentially blocking the production of wild-type and variant transthyretin protein before it is made. Quarterly, and potentially biannual, administration of vutrisiran may help to reduce deposition and facilitate the clearance of TTR amyloid deposits in tissues and potentially restore function to these tissues. Vutrisiran utilizes Alnylam’s Enhanced Stabilization ChemistryGalNAc-conjugate delivery platform, designed for increased potency and high metabolic stability that may allow for infrequent subcutaneous injections. About Alnylam Pharmaceuticals Alnylam has led the translation of RNA interference into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding 20 years ago, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam’s commercial RNAi therapeutic products are ONPATTRO®, GIVLAARI® (givosiran), OXLUMO® and Leqvio® being developed and commercialized by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of investigational medicines, including six product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefitingpatients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in Cambridge, MA.

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OptimizeRx Acquires EvinceMed, a Specialty Drug Prescription Initiation Platform

OptimizeRx Corporation | March 16, 2022

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Iktos, | June 29, 2022

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F-star Therapeutics, Inc. | June 24, 2022

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We are excited to welcome F-star employees and look forward to working with them as we invest in the company to progress and grow its clinical pipeline to realize the full potential of the platform.” Ben Toogood, Chief Executive Officer of invoX Eliot Forster, Chief Executive Officer of F-star said: “We believe our tetravalent bispecifics offer the best approach to tackle hard-to-treat cancers and other serious diseases, with the ambition to deliver longer and improved lives for patients. Today’s announcement is good news for F-star, for our shareholders and, of course, for patients. This transaction enables greater and longer-term opportunities to develop the F-star platform and accelerate delivery of our novel medicines as we work together towards a future free from cancer and other serious diseases. I’d like to thank the fantastic team at F-star as well as our partners for all their hard work, support and dedication and I’m delighted to share this exciting development.” About invoX Pharma invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a global top 40 pharmaceutical company with more than 24,000 employees. United Kingdom-based invoX is Sino Biopharm’s international expansion platform, focusing on R&D and business development activities outside of China, with a core focus on oncology and respiratory therapeutics. At its core, the Company aspires to improve patients’ lives by creating access to innovative medicine. About Sino Biopharm Sino Biopharm, together with its subsidiaries, is a leading, innovative research and development driven pharmaceutical conglomerate in China, with a business scope that is vertically integrated including research and development, manufacturing and sales and marketing infrastructure. 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