Regor Therapeutics Group

Kallyope, a New York City biotech that has raised about $480 million over the past decade, quietly released results of its Phase 2 study in obesity in an update to the US federal trials database on Wednesday. The study evaluated an experimental pill, dubbed K-757, both alone and in combination with another oral Kallyope asset, K-833. After 13 weeks of treatment, patients given K-757 monotherapy lost 1.6% of their body weight, the database update reveals, and those in the combo arm lost 2.9%. The monotherapy did not reach statistical significance versus placebo, but the combo arm did, with a p-value of 0.0008. Placebo recipients shed 0.2% of their body weight. Even so, a 2.7-point delta over placebo is nothing to write home about. Lilly’s pill orforglipron managed roughly 6.5% placebo-adjusted weight loss at 12 weeks, and oral therapies from both Structure Therapeutics and Regor Therapeutics have achieved higher weight loss at the three-month mark than what Kallyope’s products managed. In the K-757 group, 17.6% of patients lost at least 5% of their weight, versus 21.2% of those in the combo cohort. Neither hit significance versus the 11.5% figure with placebo. Doses of both Kallyope’s oral drugs were increased gradually, with K-757 reaching the maintenance dose of 120 mg twice daily on day 22 and K-833 titrated to its maintenance dose of 100 mg twice daily on day 8. Backed by large VC firms like Lux Capital and The Column Group as well as Bill Gates, Kallyope is attempting to develop oral obesity and type 2 diabetes drugs that stimulate secretion of GLP-1 and other satiety hormones and mimic the effects seen after bariatric surgery , according to an announcement from the company when the trial started in the fall of 2023. K-757 and K-833 are so-called nutrient receptor agonists that go after GLP-1, PYY and CCK, among other satiety hormones, Kallyope has said. Other small drug developers have attracted interest in these areas: In the CCK space, Aardvark Therapeutics went public this month, and CinRx Pharma nabbed $73 million last year as its portfolio company CinFina undergoes early-stage testing with a PYY analog derived from Johnson & Johnson. The Phase 2 is a pivotal moment for Kallyope, founded in 2015. The biotech is trying to crack into the hottest, potentially most lucrative area of drug R&D as pharmaceutical giants, mid-cap biotechs and new startups try developing the next wave of obesity medicines behind market leaders Novo Nordisk and Eli Lilly. Investors were likely keenly awaiting the Phase 2 data, which could dictate Kallyope’s next funding steps. The company could be nearing the end of its runway. At the time of its last raise, a $236 million Series D in February 2022, CEO Jay Galeota told Endpoints News that funding would keep the startup’s R&D engine humming for about three years. Then, last January, Bloomberg News reported that Kallyope was exploring an IPO and was reportedly working with JP Morgan on a potential listing in 2024. It didn’t follow through with a Wall Street debut last year. Other biotechs in the clinic with obesity medicines, or with intentions to explore the booming area, have gone public since then. That includes BioAge Labs, Metsera, Aardvark, Fractyl Health and MBX Biosciences. Beyond obesity and type 2 diabetes, Kallyope is also looking at migraine, celiac disease and allergies, among other areas. Kallyope also disclosed plans for a Phase 2b trial in migraine, according to a separate update to the US federal trials database on Wednesday. Elismetrep, the asset in that trial, appears to have come from Mitsubishi Tanabe Pharma, which lists the investigational medicine in its pipeline. Bain Capital is buying the centuries-old Japanese pharma for $3.3 billion . Kallyope is also working on a gastrointestinal partnership with Nxera (formerly Sosei Heptares). In 2018, it also disclosed an obesity and diabetes collaboration with Novo to discover new peptide therapies. Under their collaboration, Novo exercised an option last fall. Well-known investors have swarmed to Kallyope since its founding by Columbia University researchers Richard Axel, Tom Maniatis and Charles Zuker. Its financial backers include Bill Gates, Mubadala Investment Company, The Column Group, Lux Capital, Alexandria Venture Investments and other blue-chip names. Leading the biotech is Galeota, a 28-year Merck veteran. Former Roche CEO and chair Franz Humer is Kallyope’s board chair.

CAMBRIDGE, MA, USA I January 10, 2025 I Regor Therapeutics Group (“Regor”), a privately-held clinical-stage global biopharmaceutical company, announced topline results from its Phase 2a clinical trial for RGT-075, a leading oral once-daily small molecule full agonist of GLP-1 receptor. In the Phase 2a trial conducted at ten clinical centers across the US, RGT-075 at 125 mg once-daily delivered statistically significant 5% placebo-adjusted weight loss with no plateau at 12 weeks (six weeks on target dose) in patients living with obesity (N = 73). There were no treatment-related severe adverse events. Discontinuation rates due to any adverse events were 4%, identical for patients receiving the active treatment and those on the placebo. Only one patient (2%) required dose reduction, and she completed the study successfully at the 60 mg once-daily dose. Regor CEO Xiayang Qiu, Ph.D., commented, “The existing GLP-1 peptide drugs have demonstrated immense value and unprecedented promise. However, we have heard loud and clear the pleas of physicians and patients for an oral version that can provide sustainable benefits and be accessible for the hundreds of millions of patients living with obesity and weight-related comorbidities.” Dr. Qiu added, “We chose to pursue the small molecule route because of its proven suitability for long-term use as once-daily oral medications, along with the inherent advantage of easier manufacturing and supply in desired quantities. We succeed when patients have better options, and we believe RGT-075 has achieved an early proof-of-concept milestone through this phase 2a study.” In the RGT-075 treatment arm, at least one event of mild-to-moderate nausea and vomiting was reported for 40% and 24% patients, respectively. Michael Grimm, M.D., Ph.D., Head of Metabolic Diseases at Regor commented, “Even with only six weeks of titration, our tolerability results are already comparable to those observed for semaglutide in longer studies.” “Beyond peptide-like weight loss with no plateau at 12 weeks, RGT-075 also showed robust and clinically meaningful efficacy in HbA1c and in Systolic and Diastolic blood pressure.” RGT-075 has previously demonstrated a promising PK-profile, with a peak-to-trough ratio (PTR) of under 5. Developers hypothesize that delivering target 24-hour plasma concentration with a relatively low PTR correlates with improved tolerability to GI-related symptoms. About the COMO-1 Phase 2b development program Today Regor also announced the initiation of the COMO-1 dose-finding trial for RGT-075. The Phase 2b multicenter, randomized, double-blind, placebo-controlled study will evaluate multiple doses up to 225 mg of RGT-075 over 36 weeks compared with placebo in adult patients with obesity or overweight with weight-related comorbidities. Approximately 240 adult participants will be enrolled and randomized to RGT-075 or placebo. All participants on RGT-075 will be given RGT-075 once daily (QD) titrated up over 12 weeks. The primary endpoint is percent change in body weight from baseline to week 36. Secondary endpoints include safety and tolerability of the monthly titration scheme, as well as pharmacokinetics of RGT-075. Topline data from the Phase 2b study are expected at the end of 2025. Dr. Qiu commented, “Building upon the strong results to date, the phase 2b study is designed to provide further insights to optimize phase 3 dose selection and titration design. With our recent $850M up-front deal with Roche in breast cancer, we have the financial means to launch RGT-075 Phase 3 programs on our own, but we are genuinely interested in partnership with expert investors and companies to accelerate its path to patients and to explore rational combination approaches, expanding the potential of this best-in-class oral small molecule GLP-1 drug for sustained management of obesity and numerous weight-related comorbidities” About RGT-075 RGT-075 is an orally bioavailable, once-daily, small molecule GLP-1R full agonist discovered and developed by Regor for the treatment of metabolic diseases, such as type-2 diabetes mellitus and obesity or overweight with weight-related comorbidities. Regor previously completed Phase 2a studies in patients with obesity, Phase 1 single ascending dose (SAD) in healthy volunteers and multiple ascending dose (MAD) in patients with diabetes. RGT-075 was safe and well-tolerated in clinical trials completed to date, with emerging efficacies comparable to the approved peptide GLP-1 drugs. About Regor Therapeutics Regor Therapeutics Group is a clinical-stage biotechnology company, headquartered in Cambridge, MA and with operations in Houston, San Diego, and Shanghai, which is developing innovative and clinically differentiated medicines to address large unmet needs in oncology, metabolism, and auto-immunity. Regor is powered by the highly efficient drug discovery engine rCARD TM (Regor Computer Accelerated Rational Discovery) that enables rapid prototyping and validation of candidate molecules. This rapid approach to developing small molecules against high-profile targets is the creation of the four cofounders who collectively brought decades of experience in leading US biopharma and were previously the named inventors of 4 FDA-approved medicines. The power of the rCARD TM platform and approach has been validated by out-licensing deals with top companies, including Roche/Genentech on next-gen CDK oncology agents RGT-419B and RGT-587 (now GDC-4198 and GDC-0587) for $850M up-front payment in late 2024. To learn more about Regor, please visit us at www.regor.com . SOURCE: Regor Therapeutics

LEHI, Utah, Dec. 5, 2024 /PRNewswire/ -- Halia Therapeutics, Inc. (Halia), a clinical-stage biopharmaceutical company at the forefront of developing innovative treatments for chronic inflammatory diseases, today announced that David J. Bearss, Ph.D., Co-Founder, President and CEO of Halia Therapeutics, will present cutting-edge data on oral obesity therapeutics at the upcoming Obesity Innovation Therapeutics Summit. The conference will be held in San Diego, December 10-12, 2024. In addition, Dr. Bearss will also participate in a panel discussion addressing supply chain challenges in the obesity therapeutics landscape. The Obesity Innovation Therapeutics Summit highlights groundbreaking advancements in obesity treatment, including novel mechanisms of action, combination therapies, and strategies to enhance efficacy, durability, and muscle preservation. Presentation Details: Title: Patient-Centric Development: Exploring Oral Obesity Therapeutics to Move Away from Injectable Peptides Date: December 11, 2024 Time: 5 p.m. PT Presenter: David J. Bearss, Ph.D., Co-Founder & CEO, Halia Therapeutics Panel Details: Title: The Obesity Race on the Manufacturing Floor – Exploring Supply Challenges with Innovations in Discovery Date: December 11, 2024 Time: 2:40 p.m. PT Panelists: David J. Bearss, Ph.D., Co-Founder & CEO, Halia Therapeutics Feng Liu, Executive Director, Research & Development, Regor Pharmaceuticals Adam Mendelsohn, Chief Executive Officer, Vivani Medical About Halia Therapeutics, Inc. Halia Therapeutics is transforming the treatment landscape for chronic inflammatory and neurodegenerative diseases with a pipeline of groundbreaking therapeutics. The company's programs target NEK7 and LRRK2, key drivers of inflammation and cellular dysfunction. Halia's lead candidate, HT-6184—a novel NEK7/NLRP3 inhibitor—has demonstrated safety and tolerability in Phase I trials (NCT05447546) with single and multiple escalating oral doses in healthy volunteers. It is now being evaluated in two Phase II studies: one assessing its efficacy in treating lower-risk myelodysplastic syndromes (LR-MDS) and another exploring its role in mitigating post-procedural inflammation and pain (NCT06241742). Halia recently initiated a Phase I trial for HT-4253, an innovative LRRK2 inhibitor targeting neurodegenerative diseases, in healthy volunteers (NCT06537817). Based in Lehi, Utah, Halia Therapeutics is dedicated to advancing patient care through science-driven innovation. Learn more at and follow us on LinkedIn and Twitter (X). Company Contact Halia Therapeutics [email protected] +1 (385) 355-4315 Media Contact: Ignacio Guerrero-Ros, Ph.D. Russo Partners, LLC +1 (646) 942-5604 [email protected] SOURCE Halia Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED