UK MHRA Approval Received for First-In-Human Trial of Rincell-1, a First-In-Class Regenerative Cell Therapy for Sensorineural Hearing Loss
Sheffield, July 01, 2025 (GLOBE NEWSWIRE) --UK MHRA Approval Received for First-In-Human Trial of Rincell-1,
a First-In-Class Regenerative Cell Therapy for Sensorineural Hearing LossRincell-1 addresses a multi $Bn global market opportunity
where no disease modifying treatments currently exist
Sheffield, UK, July 1 2025 – Rinri Therapeutics, a world leading company focused on transforming sensorineural hearing loss (SNHL) with regenerative cell therapy, is pleased to announce the approval of its Clinical Trial Application (CTA) from the UK MHRA for its lead asset Rincell-1. Clinical proof-of-concept data from the first-in-human Phase I/IIa trial1 of Rincell-1, a first-in-class otic neural progenitor cell therapy, is expected within 12 months of trial initiation.
While current standard-of-care treatments like cochlear implants help manage the symptoms of sensorineural hearing loss, their effectiveness depends on the integrity of the cochlear nerve. Rincell-1 has been designed to regenerate damaged auditory neurons, for which no treatment currently exists, bringing the potential to transform the lives of people with neural hearing loss and to play a significant role in healthy aging.
Taking place at three leading hearing research centres in the UK, the randomised open-label trial will involve 20 patients undergoing cochlear implantation for hearing loss, 10 with postsynaptic auditory neuropathy spectrum disorder (ANSD) and 10 with severe-to-profound age-related hearing loss (presbycusis). Within each group, patients will be randomly assigned to receive a single dose of Rincell-1 in addition to cochlear implantation or cochlear implantation alone.
The study is powered to measure safety and detect significant changes in neural health, as measured by telemetry from Advanced Bionics' cochlear implant monitoring AIMTM system, alongside a range of speech perception measures and patient-reported outcomes. Rincell-1 will be delivered to the cochlea during cochlear implant surgery via a novel extension of the current procedure, as previously published in 2024.2
Dr Simon Chandler, CEO of Rinri Therapeutics, said, 'Approval to start our first clinical trial with Rincell-1 in hearing loss is a major milestone and recognition of the potential of our regenerative cell therapy in this area of significant unmet medical need. I'd like to thank our staff and partners for their meticulous work towards this achievement, and our investors, Boehringer Ingelheim Venture Fund, UCB Ventures and Pioneer Group, for their support.'
Professor Doug Hartley, CMO of Rinri Therapeutics & Chief Investigator on the trial, said, 'Working daily with individuals suffering from hearing loss, I know how devastating it can be, and the acute need for a therapy to change the disease course. It's very exciting to be starting a clinical trial with Rincell-1, working with otologists across the world to develop this promising new approach to auditory nerve regeneration.'
--ENDS—
1 First in human, multi-centre open-label randomised trial to assess the safety of Rincell-1 otic neural progenitor cell-based therapy in addition to standard care, compared with standard care alone, in participants with presbycusis or postsynaptic auditory neuropathy who meet UK guidelines for Cochlear Implantation. IRAS Ref: 1006992. Clin trials gov NCT07032038
2 Novel procedure for cell delivery in Rinri Therapeutics' first clinical trial described in peer-reviewed publication
For more information contact:
Dr Simon Chandler, CEO enquiries@rinri-therapeutics.com
About Rinri Therapeutics
Rinri Therapeutics is focused on transforming sensorineural hearing loss (SNHL) with regenerative cell therapy, providing new therapeutic options for the treatment of this major global unmet medical need. It is developing first-in-class allogenic cell therapy products to treat hearing loss using its proprietary Otic Sensory Progenitor REgenerative therapY (OSPREY™) platform.
There are currently no approved therapeutics for the estimated more than 7m people living with neural hearing loss globally, giving Rinri Therapeutics' cell therapies a multi-billion dollar sales potential. The company is headquartered in Sheffield, UK, and backed by UCB Ventures, Boehringer Ingelheim Venture Fund and Pioneer Group. For more information, please visit https://www.rinri-therapeutics.com/ or follow us on LinkedIn.
CONTACT: For more information contact: Dr Simon Chandler, CEO enquiries@rinri-therapeutics.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
a minute ago
- Yahoo
Donald Trump to open resort's second golf course on final day in Scotland
Donald Trump will officially open his new golf course in Aberdeenshire on the final day of his visit to Scotland. The US president's fifth day in Scotland on Tuesday follows a meeting and press conference with Sir Keir Starmer on Monday. Mr Trump will cut the ribbon on a second 18-hole course at his resort in Menie, Aberdeenshire before he flies back to the US on Air Force One. The president has played several rounds of golf during his Scottish trip, teeing off at his other resort in Turnberry, Ayrshire, on Saturday, Sunday and Monday. As they met at Turnberry for bilateral talks on trade and the situation in Gaza, Mr Trump and Sir Keir took part in what proved to be a lengthy press conference, with the president discussing a number of topics. The Republican Party leader spoke of his 'great love' for Scotland and said he wanted to see the nation 'thrive'. He returned to his long-running objections to wind turbines, branding them 'ugly monsters' and speaking of his admiration for North Sea oil and gas. Discussing the war in Ukraine, Mr Trump said he was 'very disappointed' in Russian President Vladimir Putin and suggested he would bring forward a deadline for Russia to agree to a ceasefire. The US president called Sir Sadiq Khan a 'nasty person', which prompted Sir Keir to come to the defence of his 'friend' the London Mayor. Construction of the new course in Menie began in 2023, with Mr Trump and his son Eric breaking ground on the project. Trump International Scotland claims the two courses will be the 'greatest 36 holes in golf'. The second course is expected to be dedicated to the president's mother, Mary Anne MacLeod, who was born on the Isle of Lewis. Critics say the Trump developments in Scotland have not delivered as many jobs as promised and work at the Menie site has caused environmental damage. Mr Trump and Sir Keir landed at Menie aboard Marine One, the president's helicopter, which was seen circling the new course before it touched down on Monday evening. The president then hosted a dinner at Menie with members of his family and guests including Scottish First Minister John Swinney. A demonstration took place in Balmedie, near the resort, on Monday. A small number of protesters sat at the roadside in the centre of the village, surrounded by cardboard signs bearing anti-Trump slogans.
Yahoo
31 minutes ago
- Yahoo
Trump's New EU Trade Deal Labeled 'Bad News' By Economists As Dow Futures Spike Over 150 Points
Benzinga and Yahoo Finance LLC may earn commission or revenue on some items through the links below. President Donald Trump's latest trade deal with the European Union is drawing sharp criticism from several leading economists, who argue that it will disproportionately harm American consumers and businesses. What Happened: Following Trump's announcement on Sunday, economist Peter Schiff posted on X, with a blunt assessment of the deal, saying that 'Americans lose again.' Schiff says that under the new terms, 'we will pay 15% tariffs to buy most European goods, but 50% tariffs to buy European steel, aluminum, or copper, driving up material costs for many U.S industries.' Meanwhile, he notes, 'Europeans won't pay any tariffs on most U.S. imports.' Trending: Be part of the breakthrough that could replace plastic as we know it—University of Michigan economist Justin Wolfers echoed similar concerns, while highlighting the folly of imposing trade barriers. 'These trade deals are all underwhelming for one simple reason,' he says, and that's because trade barriers and tariffs have been tiny for decades. 'When tariffs are 1-2%, there's not much to gain from a trade war,' he says, while warning that a 15% tax on imports can, however, 'do a lot of harm to Americans.' Danish economist Lars Christensen pushed back against the narrative that this was a bad deal for the EU and a win for Trump. He says, 'the deal lower[s] EU tariffs,' which he believes is 'good news for European consumers,' while adding that it is bad for the U.S. economy. Christensen agrees with both Schiff and Wolfers, saying that 'the biggest losers are US consumers,' while comparing the deal to 'shooting yourself in the foot' for the U.S., which he says 'is never a victory.'Why It Matters: The announcement of the trade deal with the EU on Sunday brought an end to months of trade and tariff-related uncertainties with the U.S.'s biggest trading partner. Besides the 15% tariff on imports from the region, the EU will also be buying $750 billion worth of U.S. energy, while investing $600 billion in the United States. Additionally, nations in the bloc will be purchasing weapons from the U.S., although no amount was mentioned. Meanwhile, top officials from the U.S. and China are set to meet in Stockholm to address pressing trade issues, with Trump saying last week that 'We have the confines of a deal with China.' U.S. stock futures are up pre-market, following news of the trade deal over the weekend. The S&P 500 Futures are up 0.37%, trading at 6,449.00, and Nasdaq Futures at 23,538.25, up 0.50%, followed by Dow Futures, which rose over 150 points, up 0.33%, trading at 45,234.00, at the time of writing. Photo Courtesy: Savvapanf Photo on Read Next: $100k+ in investable assets? Match with a fiduciary advisor for free to learn how you can maximize your retirement and save on taxes – no cost, no obligation. If there was a new fund backed by Jeff Bezos offering a 7-9% target yield with monthly dividends would you invest in it? This article Trump's New EU Trade Deal Labeled 'Bad News' By Economists As Dow Futures Spike Over 150 Points originally appeared on
Bloomberg
33 minutes ago
- Bloomberg
Taiwan Investors Turn to Europe as US Assets Lose their Allure
Taiwanese investors are reassessing their long-held preference for US-dollar assets, shifting their bets to Europe in the latest move by global investors away from the greenback. Taiwanese funds holding European assets have seen an influx of investments recently, pushing their combined value to NT$13.7 billion ($463 million) as of the end of June, the highest since 2019, according to data compiled by Bloomberg.
