PDE10A

LONDON, UK I August 31, 2023 I BenevolentAI ("BenevolentAI" or the "Company") (Euronext Amsterdam: BAI), a leader in the development of advanced AI that accelerates biopharma discovery, today announces that the first participants have been dosed in Phase I first-in-human studies of its oral phosphodiesterase 10 (PDE10) inhibitor, BEN-8744, intended for the treatment of Ulcerative Colitis (UC). The topline data readout from this study is expected in Q1 2024. Dr. Anne Phelan, Chief Scientific Officer of BenevolentAI, said: “ UC is a disease with significant unmet patient needs, as rates of sustained remission remain disappointingly low. Initiation of this Phase I study marks a significant milestone in treating this complex disease and serves as the leading asset in our clinical development portfolio. BEN-8744 exemplifies our innovative approach targeting a novel pathway with the potential for meaningful differentiation from existing standard-of-care treatments.” Joanna Shields, Chief Executive Officer of BenevolentAI, said: “Our AI powered drug-discovery platform identified PDE10 as a novel target for UC, with no prior direct associations linking it in scientific literature. BEN-8744 demonstrates the capacity of our technology platform to uncover novel avenues in the treatment of disease.” About BEN-8744 BEN-8744 is a peripherally restricted small molecule PDE10 inhibitor in development as a potential first-in-class treatment for Ulcerative Colitis (UC). Administered orally, it also has the potential for addressing other indications within inflammatory bowel disease. BEN-8744 constitutes a different mechanism of action for the treatment of UC, providing an opportunity for further differentiation based on safety and efficacy. PDE10 reduces intracellular levels of the signalling molecule cGMP. Restoration of cGMP levels by PDE10 inhibition is anticipated to have a direct anti-inflammatory and disease-modifying benefit. BEN-8744 is a wholly owned asset in the BenevolentAI drug programme pipeline. About Ulcerative Colitis UC is a chronic disease that causes inflammation and ulceration of the inner lining of the colon and rectum. UC affects 0.4% of the US population, and 31% of patients have moderate-to-severe disease. 20-40% of those patients with moderate-to-severe UC do not respond to anti-TNF, the main treatment approach, whilst currently available treatments may come with severe side effects. About BenevolentAI BenevolentAI (AMS: BAI) is a leading developer of advanced artificial intelligence technologies that unlock the value of multimodal data, surface novel insights, and accelerate biomedical discovery. Through the combined capabilities of its AI platform, its scientific expertise, and wet-lab facilities, the Company is developing an inhouse drug pipeline of high-value assets. The Company is headquartered in London, with a research facility in Cambridge (UK) and a further office in New York. SOURCE: BenevolentAI

The funding will be put towards development of its diversified pipeline focused on central nervous system disorders. The round was co-led by European healthcare focused investment firms, Forbion and Jeito Capital. UPMC Enterprises and an additional new investor joined existing investors Sofinnova Partners, Polaris Partners, Gilde Healthcare and Invus to complete the round. The proceeds of the financing will be used to advance the company’s lead compound basimglurant (NOE-101), an mGluR5 inhibitor which is being evaluated in phase 2b clinical trials for severe pain in trigeminal neuralgia (TN) and seizures in tuberous sclerosis complex (TSC). Noema is also developing gemlapodect (NOE-105), a PDE10a inhibitor being evaluated in phase 2b clinical trials for Tourette syndrome and childhood onset fluency disorder (COFD) or stuttering; and NOE-115, a phase 2 ready, triple reuptake inhibitor for atypical depression and binge eating disorder. “We are excited to announce the successful completion of this oversubscribed Series B financing round and very pleased to have a world-class group of investors supporting our vision of bringing much-needed treatments to those living with debilitating central nervous system disorders," said Luigi Costa, Chief Executive Officer of Noema Pharma. “We welcome our new investors who bring extensive expertise and knowledge of drug development and company building and add further strength to our robust investor base. This financing comes at a key time for Noema Pharma as we look forward to extensive news flow over the next 24 months.” googletag.cmd.push(function () { googletag.display('text-ad1'); }); Following the close of the financing, Nanna Lüneborg from Forbion and Rachel Mears from Jeito Capital will join the Board of Directors of Noema Pharma. Lüneborg, general partner at Forbion, said: “We have been following Noema since inception and have been impressed by the quality and progress of Noema Pharma’s clinical pipeline. We believe this is the right time to invest as the company has started to generate very encouraging clinical data in indications of high unmet need and particularly with its lead asset basimglurant.” Mears, a partner at Jeito added: “One of the pillars of our investment strategy is to deploy capital in truly differentiated and innovative therapies with high unmet medical need. The research and clinical work being undertaken by Noema Pharma fit these criteria exactly. The dedication of the Noema team and the quality of their work is clear to see and positions the company as the upcoming global leader in its field.” The series B financing follows a $60 million series A financing concluded in December 2020, led by Sofinnova Partners and Polaris Partners. Noema Pharma was founded in 2019 with a seed investment from Sofinnova Partners and four clinical stage assets in-licensed from Roche. Antoine Papiernik, chairman and managing partner of Sofinnova Partners “As co-founders and initial investors of Noema Pharma, we are incredibly proud of what the company has accomplished since its inception,” said. “Raising an oversubscribed funding round of this magnitude is a significant achievement that further reinforces our conviction that Noema can make a meaningful difference in the lives of patients suffering from debilitating CNS disorders.”

Swiss biotech Noema Pharma jumpstarted back in 2020 with a $60 million Series A financing round. Today, it’s wrapping up its Series B round with another $112 million to develop its pipeline of molecules focused on central nervous system disorders. Noema, a spinout from Roche, started out with four clinical stage assets in-licensed from Roche. The company says it will use this new round of financing to push forward its lead candidate basimglurant (NOE-101), an mGluR5 inhibitor which is currently being evaluated in Phase IIb clinical trials for severe pain in trigeminal neuralgia and seizures in tuberous sclerosis complex. Noema is also developing gemlapodect (NOE-105), a PDE10a inhibitor, in Phase IIb trials for Tourette syndrome and stuttering. A Phase IIb trial readout of gemlapodect in stuttering is expected in the next 12 months. NOE-115, a triple reuptake inhibitor for atypical depression and binge eating disorder, is Phase-II ready. “All of these molecules have been studied before in other indications. Roche has invested a lot in that and we have a lot of data that shows activity and also shows those molecules are safe,” CEO Luigi Costa said. “We will start another Phase II/III study in Tourette syndrome because we have completed a Phase IIa in adult patients and then we were encouraged to proceed into phase two which will include adult and adolescent patients,” Costa added. Costa said the indications for the drug candidates were chosen because they are either poorly treated with current available medications and surgeries or because there are no therapies at all. Most patients with stuttering, also known as childhood onset fluency disorder (COFD), for example, go into speech therapy — which doesn’t work for everyone. For the people who did not see positive change with therapy, gemlapodect could be the answer. Antoine Papiernik, chairman and managing partner at Sofinnova Partners, one of the founding investors, said the “beauty here is in the pipeline.” “It’s a pipeline of having a bunch of molecules. It’s a pipeline even within each of these molecules that are being developed in several indications,” Papiernik told Endpoints News . “So you know, [NOE] 101, TSC and trigeminal neuralgia, you don’t have all your eggs in one basket, and you really have two shots on goal.” It was George Garibaldi, former head of neuroscience product development at Roche for a decade, who first chose the compounds to license after Roche decided to shelve part of its psychiatry pipeline. The company started out with six staffers and now has 18, Costa said. The Series B round was co-led by Forbion and Jeito Capital. UPMC Enterprises joined previous investors Sofinnova Partners, Polaris Partners, Gilde Healthcare and Invus. Following the close of the Series B, Nanna Lüneborg from Forbion and Rachel Mears from Jeito Capital will join the board of directors of Noema Pharma.