Lenomorelin

01 研究背景 胃生长激素释放肽（Ghrelin），别名“胃饥饿素”，是一种在胃肠道中分泌的肽类物质，它在调节食欲和能量代谢中起着关键作用。当人体处于饥饿状态时，胃底会大量分泌胃饥饿素，从而增加食欲，促进食物摄入。胃饥饿素通过与大脑中的特定受体结合，影响下丘脑的食欲调节中心，进而调节食欲和能量代谢。胃饥饿素的作用包括增加食欲、减少能量消耗、促进脂肪储存。在减肥过程中，胃饥饿素的水平通常较高，这可能导致食欲增加和能量摄入增加。因此，通过调节胃饥饿素的水平，可以帮助控制食欲，促进减肥。目前，针对胃饥饿素的药物和治疗方法正在研究之中，旨在通过抑制胃饥饿激素的分泌或降低其活性，达到减肥的效果。 近日，浙江大学南科望研究员、香港城市大学于欣格教授和麻省理工学院Giovanni Traverso教授三校联合，另辟蹊径地寻求运用非药物、无创、可远程操控的方法来调节活体内的胃饥饿素水平。该团队合力研发了一款可吞服、无电池、组织粘附的软体机器人（IngRI）用于非侵入性的胃部电刺激，并在成年猪体内实现了胃饥饿素水平的调节。该工作“An ingestible, battery-free, tissue-adhering robotic interface for non-invasive and chronic electrostimulation of the gut.”发表于Nature Communications，浙江大学药学院为本研究第一单位。 02 文章解析 论文展示了一个创新的可吞服软体机器人IngRI（图1），它是一种设计用于在消化道内进行无线长期电刺激的设备。IngRI最初被封装在一个明胶胶囊中，当胶囊进入肠道后，它会溶解并释放出折叠的IngRI。一旦释放，IngRI可以利用外部手持磁铁的帮助，在肠道中导航至所需的位置，特别是胃部。到达目标位置后，IngRI利用仿生水凝胶的粘附作用，牢固地附着在胃粘膜上，确保设备的稳定性和适形电极与组织的有效接触。通过近场感应耦合，IngRI能够提供可编程的电脉冲，用于刺激胃肠道中具有电兴奋性的细胞，以达到治疗的目的。这种设备的设计克服了传统可摄入电刺激设备的一些限制，如电极与组织接触不良和电池寿命有限，为胃肠道疾病的治疗提供了新的可能性。 图1.可吞服软体机器人设计 总结 这项研究展示了一种概念性的软体机器人（IngRI），用于实现胃肠道的可吞服、无线电刺激。离体和体内测试均表明，该软设备架构比现有的刚性电刺激装置具有更好的电极组织接触和更长的胃滞留时间。IngRI提供的短脉冲刺激进一步导致血浆胃饥饿素水平增加，可激活生长激素促分泌素受体（GHS-R）并刺激食物摄入和脂肪沉积。这些数据支持通过非药物神经调节调节食欲和治疗其他疾病的潜力。 供稿人：南科望 修稿：李丽萍 审核：王毅

AUSTIN, Texas, April 18, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, announced today that abstracts reviewing data from its Phase 2 OraGrowtH210 and OraGrowtH212 Trials will be presented at several upcoming medical meetings in the US and Europe. Pediatric Endocrine Society (PES) Annual Meeting, held May 2-5, 2024, in Chicago, IL Abstract, OraGrowtH210 Trial (Phase 2): Oral LUM-201 Shows Similar Annualized Height Velocity to Daily rhGH in Moderate Pediatric Growth Hormone Deficiency (PGHD) with a 1.6mg/kg/day Dose and a Promising Investigational Safety Record, Andrew Dauber, MD, et al, to be presented in a poster session, Friday, May 3rd, 12:15-1:45 PM CT The 10th International Congress of the Growth Hormone Research Society (GRS), held May 10-11, 2024, in Stockholm, Sweden Abstract, Approaching the reality of restoring GH secretion and growth with the investigative oral growth hormone secretagogue (GHS) LUM-201 in moderate Pediatric Growth Hormone Deficiency (PGHD), Peter Clayton, MD, PhD, et al, to be presented in an oral session, Friday, May 10th, 12:00-1:00 PM CET European Congress of Endocrinology (ECE) 2024, held May 11-14, 2024, in Stockholm, Sweden Abstract, Approaching the reality of restoring GH secretion and growth with the investigative oral growth hormone secretagogue (GHS) LUM-201 in moderate Pediatric Growth Hormone Deficiency (PGHD), Peter Clayton, MD, PhD, et al, to be presented in an oral session, Sunday, May 12th, 4:20-6:00 PM CET “We are excited to share additional data analyses from our Phase 2 OraGrowtH Trials with the global endocrine community at these key medical meetings,” said Rick Hawkins, Lumos Pharma’s Chairman and CEO. “Our Phase 2 data to date have demonstrated that, by augmenting the natural pulsatile secretion of growth hormone, our oral therapeutic candidate, LUM-201, produces comparable growth to injectable rhGH with significantly less exposure to circulating GH. We believe this information will continue to resonate throughout the endocrine community and that oral LUM-201 could create a paradigm shift in the way PGHD and other growth hormone disorders are treated.” About LUM-201 LUM-201 (ibutamoren) is an orally administered small molecule that promotes the secretion (secretagogue) of Growth Hormone (GH) from the pituitary gland.1 LUM-201 acts as an agonist of the GH Secretagogue Receptor to stimulate GH release and to suppress the release of somatostatin.2 LUM-201 has been observed to increase the amplitude of endogenous pulsatile GH secretion in humans, which mimics the natural pattern of GH secretion. 3,4 This therapeutic candidate has been studied in more than 1,300 patients, both adult and pediatric, and was generally well tolerated with the most commonly reported adverse events being digestive systems events, including appetite increase. Mild elevations in liver enzymes without accompanying changes in bilirubin were also reported. LUM-201 has received Orphan Drug Designation in both the US and EU. About Lumos Pharma Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases. The Company was founded and is led by a management team with longstanding experience in rare disease drug development. Lumos Pharma’s lead therapeutic candidate, LUM-201, is a novel, oral growth hormone (GH) secretagogue, seeking to transform the ~$4.7B global GH market from injectable to oral therapy. LUM-201 is currently being evaluated in multiple Phase 2 clinical studies in Pediatric Growth Hormone Deficiency (PGHD) and has received Orphan Drug Designation in both the US and EU. For more information, please visit . 1 Patchett A.A., et al. Design and Biological Activities of L-163,191 (MK-0677): A Potent, Orally Active Growth Hormone Secretagogue, Proc Natl Acad Sci, 1995, 92:7001-7005. 2 Howard A.D., et al. A Receptor in Pituitary and Hypothalamus that Functions in Growth Hormone Release, Science, 1996, 273:974-977. 3 Nass R., et al. Effects of an Oral Ghrelin Mimetic on Body Composition and Clinical Outcomes in Healthy Older Adults, Ann Intern Med, 2008, 149:601-611. 4 Chapman I.M., et al. Oral Administration of Growth Hormone (GH) Releasing Peptide-Mimetic MK-677 Stimulates the GH/Insulin-Like Growth Factor-I Axis in Selected GH-Deficient Adults, J Clin Endocrinol Metab, 1997, 82(10):3455-3463. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements of Lumos Pharma, Inc. that involve substantial risks and uncertainties. All such statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. A law that, in part, gives us the opportunity to share our outlook for the future without fear of litigation if it turns out our predictions were not correct. We are passionate about our business - including LUM-201 and the potential it may have to help patients in the clinic. This passion feeds our optimism that our efforts will be successful and bring about meaningful change for patients. Please keep in mind that actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. We have attempted to identify forward-looking statements by using words such as “projected,” "upcoming," "will," “would,” “should,” "plan," “intend,” "anticipate," "approximate," "expect," “potential,” “imminent,” and similar references to future periods or the negative of these terms. Not all forward-looking statements contain these identifying words. Examples of forward-looking statements include, among others, statements we make regarding the advancement of oral LUM-201 to Phase 3, the potential for LUM-201 to be the first oral therapeutic for PGHD, and any other statements other than statements of historical fact. We wish we were able to predict the future with 100% accuracy, but that just is not possible. Our forward-looking statements are neither historical facts nor assurances of future performance. You should not rely on any of these forward-looking statements and, to help you make your own risk determinations, we have provided an extensive discussion of risks that could cause actual results to differ materially from our forward-looking statements including risks related to the continued analysis of data from our LUM-201 Trials, the timing and outcome of our future interactions with regulatory authorities including our end of Phase 2 meeting with the FDA, the timing and ability of Lumos to raise additional equity capital as needed to fund our Phase 3 Trial, our ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the ability to structure our Phase 3 trial in an effective and timely manner, the ability to successfully develop our product candidate, the effects of pandemics, other widespread health problems or military conflicts including the Ukraine-Russia conflict and the Middle East conflict and other risks could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements including information in the "Risk Factors" section and elsewhere in Lumos Pharma’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as other reports filed with the SEC including our most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2023. All of these documents are available on our website. Before making any decisions concerning our stock, you should read and understand those documents. We anticipate that subsequent events and developments will cause our views to change. We may choose to update these forward-looking statements at some point in the future, however, we disclaim any obligation to do so. As a result, you should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Investor & Media Contact: Lisa Miller Lumos Pharma Investor Relations 512-792-5454 ir@lumos-pharma.com Source: Lumos Pharma, Inc.