Longevity investment bulletin: UNITY, NeuroSense, Huma and more

The latest longevity updates from our investment news desk.

Unity AMD trial fails to show non-inferiority

Shares in longevity biotech company UNITY Biotechnology [Nasdaq: UBX] fell sharply after it announced results from Part A of its Phase 2 study in patients with wet age-related macular degeneration (AMD). The study did not meet the non-inferiority threshold compared to Regeneron’s drug aflibercept through 24 weeks.

“Following a full analysis of ENVISION results, we will assess and optimize our resource allocation for future development of UBX1325,” said Anirvan Ghosh, CEO of UNITY. “In the weeks ahead we will provide an update on Part B of the ENVISION study, and importantly, share 48-week data from the Phase 2 BEHOLD DME study. In DME, UBX1325 showed strong evidence of biologic activity and improvement in visual acuity – and, as a result, we plan to initiate a Phase 2b study in the second half of this year.”

NeuroSense partners with Mass General on ALS

Neurodegenerative disease biotech NeuroSense Therapeutics (Nasdaq: NRSN) signed a collaboration agreement with Massachusetts General Hospital’s NeuroEpigenetics Lab. The partnership will explore the neurotherapeutic effects of NeuroSense’s combination drug, PrimeC, which uses a novel in vitro model generated from post-mortem ALS brain tissue.

The objective of the collaborative studies is to expand the understanding of PrimeC’s mechanism of action in attenuating ALS-related pathology, specifically TDP-43 accumulation, autophagy defects, mitochondrial dysfunction, and oxidative stress.

“We are excited to join NeuroSense in its mission to advance PrimeC for people living with ALS,” said Dr Sadri-Vakili, Associate Professor at Harvard Medical School and the Director of the NeuroEpigenetics laboratory. “Our laboratory prides itself on partnering with industry collaborators to assess the neuroprotective efficacy of new treatments with the hopes of identifying novel therapies for ALS,” Dr Ghazaleh Sadri-Vakili, Our in vitro model may serve as an effective tool to increase our understanding of PrimeC’s neurotherapeutic mechanism of action.”

Huma receives key EU certification

Digital health company Huma Therapeutics announced it has become the only company in the world to receive EU MDR Class IIb certification for disease agnostic Software as a Medical Device. The company’s SaMD platform powers digital health pathways through which data are collected from patients for self-management or to be assessed centrally by clinicians. These include remote patient monitoring systems, companion apps, risk assessment tools, dose calculators, algorithms.

Achieving Class IIb certification means that the SaMD platform is permitted to monitor patients of all ages with any condition – including infants and in pregnancy – and can connect with a range of external devices, such as heart rate, blood sugar monitors or smart inhalers. The platform is now able to host machine learning algorithms that can support risk prediction, diagnosis and prognostication.

“We have spent more than a decade advancing our platform and we are delighted to see this validated by achieving Class IIb certification which is a breakthrough for the entire digital health industry,” ‍said Dan Vahdat, CEO of Huma. “Now, instead of spending years developing a regulated app at a cost sometimes running into tens of millions of dollars, companies can configure our Class IIb-approved platform to their specific needs, thus reducing risk and democratizing innovation in digital health.”

Longevity TV series planned

Exploring the latest in research, technology, and innovations in the field of longevity, a new docuseries aims to reveal the surprising and dramatic changes in the way humanity will soon approach and think of aging. Involving real-life, everyday people interacting with longevity technologies, ‘Reversed: The Race for Longevity’ aims to reach the masses with a message of hope and excitement.

Hosted by longevity technology expert Nick Engerer, the series will call upon a team of scientific experts, entrepreneurs, and visionaries, including, Robert Lufkin, Nikolina and Gordan Lauc, Bradley Schurman, Ryan Smith, Liz Parrish, Joel Furhman, Nir Barzilai, Ken Berry, and Jason Fung.

“It is now time to bring the longevity transition’s message of hope and possibility to the millions of people whose lives will soon change for the better,” said Engerer.