Latest news with #InvestigationalNewDrug
Associated Press
2 days ago
- Business
- Associated Press
Bambusa Therapeutics Announces First Subject Dosed in Phase 1 Clinical Trial of BBT002, A Novel Platform-In-A-Molecule Bispecific Antibody for Broad I&I Conditions and U.S. FDA Clearance of IND Application for BBT001
BOSTON, May 30, 2025 /PRNewswire/ -- Bambusa Therapeutics, Inc. (Bambusa), a clinical-stage biotechnology company developing novel biologics for inflammatory and immunological diseases, today announced that it has completed the initial dosing in healthy volunteers (HV) in its clinical trial for BBT002, a novel, half-life extended bispecific antibody designed as a 'platform in a molecule' with broad applications across respiratory, dermatology, and gastroenterology. The Phase 1 clinical trial (BBT002-001; NCT06944925 ) is a randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study evaluating BBT002 in healthy volunteers and adults with COPD. The study will evaluate safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and preliminary efficacy of BBT002. Approximately 96 participants are expected to enroll across multiple sites. Interim safety and pharmacokinetic data are anticipated in the first quarter of 2026. Bambusa is also considering expanding into additional indications including asthma, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis and food allergy, to fully realize the 'platform-in-a-molecule' potential for BBT002. 'Advancing our second program into the clinic within just 12 months of founding Bambusa reflects the speed, precision, and high standards that define our development culture,' said Thang Ho, PhD, Senior Vice President of Development Sciences at Bambusa Therapeutics. 'BBT002's dual-target mechanism leverages two of the most classic and fundamental inflammatory pathways—enabling a rational, biology-driven approach to push the efficacy ceiling beyond what single-target therapies can achieve. We believe this strategy may offer additive or synergistic benefit, particularly for patients with complex, multi-organ inflammatory diseases. This milestone highlights our team's ability to rapidly translate bold science into clinical-stage programs with broad impact.' Separately, Bambusa also announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to proceed with the clinical development of BBT001, a novel multi-targeting, half-life extended bispecific antibody for the treatment of atopic dermatitis and other inflammatory skin diseases. BBT001 is currently being studied in a randomized, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study conducted in Australia, evaluating BBT001 in healthy volunteers and adults with moderate to severe atopic dermatitis. About Bambusa's pipeline BBT001 is a novel half-life extended bispecific antibody. Preclinical data with BBT001 demonstrate its best-in-disease potential, offering enhanced efficacy and improved dosing convenience compared to approved biologics in atopic dermatitis. It is currently being tested in a Phase I clinical study (BBT001-001; NCT06808477) BBT002 is a novel half-life extended bispecific antibody designed as a 'platform in a molecule' with broad applications across respiratory, dermatology, and gastroenterology indications. Preclinical data with BBT002 demonstrate its best-in-disease potential, offering enhanced efficacy and improved dosing convenience compared to approved biologics across multiple inflammatory conditions. It is currently being tested in a Phase I clinical study (BBT002-001; NCT06944925 ). The company's additional pipeline candidates, BBT003 and BBT004, are being developed for inflammatory bowel disease and rheumatological conditions, each with best-in-disease potential. About Bambusa Therapeutics Bambusa Therapeutics is a clinical-stage biotechnology company specializing in developing transformative inflammatory and immunological therapeutics. Based in the vibrant Boston Seaport area, Bambusa's mission is to advance the field of immunology with cutting-edge solutions. For more information, visit View original content to download multimedia: SOURCE Bambusa Therapeutics
Yahoo
2 days ago
- Business
- Yahoo
BioAge Labs, Inc. (BIOA)'s BGE-102 Shows Potent Weight Loss, Plans IND Submission Mid-2025
BioAge Labs, Inc. (NASDAQ:BIOA), a clinical-stage biotech innovator, announced today the completion of IND-enabling studies for its groundbreaking oral NLRP3 inhibitor, BGE-102, targeting obesity. The company plans to submit an Investigational New Drug (IND) application by mid-2025, with first Phase 1 single ascending dose (SAD) data expected by year-end. A scientist in a lab coat analyzing samples from a petri dish, studying the effects of a potential drug candidate. BGE-102, an internally discovered compound, is distinguished by its novel binding site, high potency, and brain penetration. In preclinical obesity models, BGE-102 delivered dose-dependent weight loss comparable to leading GLP-1 agonist semaglutide, achieving up to 15% reduction as monotherapy and over 20% when combined with semaglutide. The drug also improved insulin sensitivity and demonstrated a robust safety margin in toxicology studies. BioAge Labs, Inc. (NASDAQ:BIOA)'s CEO, Kristen Fortney, Ph.D., highlighted BGE-102's potential as a once-daily oral therapy, either alone or with GLP-1 receptor agonists, by targeting the NLRP3 inflammasome, a key driver of inflammation and metabolic dysfunction in obesity. Pending IND clearance, BioAge Labs, Inc. (NASDAQ:BIOA) will launch Phase 1 trials, with a Phase 1b proof-of-concept study in obesity planned for late 2026. While we acknowledge the potential of BIOA to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BIOA and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
3 days ago
- Business
- Business Wire
iVeena Announces IND Submission to the U.S. FDA for a Phase 2 Clinical Trial for Pediatric Myopia
SALT LAKE CITY--(BUSINESS WIRE)-- iVeena Delivery Systems Inc. ('iVeena'), a biopharmaceutical company advancing IVMED-85 for the treatment of pediatric myopia, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for IVMED-85 for the treatment of pediatric myopia. 'Today's announcement is an important milestone for iVeena in our journey to offer patients a novel therapeutic option,' said President and Founder, Bala Ambati, M.D., Ph.D., MBA. 'I am extremely proud of the remarkable commitment of the team at iVeena and look forward to initiating our multinational Phase 2 study in the coming months.' 'This IND marks a major step toward meeting a significant unmet need for patients. IVMED-85's novel LOX-based mechanism offers a differentiated, non-atropine approach that could redefine how we treat pediatric myopia,' said Vance Thompson, M.D., Founder of Vance Thompson Vision Sioux Falls, South Dakota, and the Director of Refractive Surgery. An IND submission is a request submitted to the FDA seeking permission to test a new drug or therapeutic substance in humans. The submission includes detailed information about the drug, its composition, pharmacology, toxicology data from preclinical studies, proposed clinical trial protocols, and information on manufacturing and quality control. With the IND application submission now complete, the FDA is expected to provide its review within approximately 30 days. Pending approval, the company plans to initiate the multinational clinical trial in 2025. About IVMED-85 Lead program IVMED-85 is a new chemical entity (NCE), preservative-free prescription eye drop to prevent myopic progression. IVMED-85 is a non-surgical, non-invasive, non-atropine daily eye drop that strengthens scleral and corneal collagen crosslinks through LOX activation, potentially leading to improved refraction and a decrease in the rate of axial elongation. About iVeena iVeena Delivery Systems, Inc. is a privately held, clinical stage ophthalmology company developing disease-modifying pharmacologic innovations for refractive diseases. iVeena has licensed its lead asset to Glaukos Corporation, IVMED-80, an Orphan Drug Designated eye drop for keratoconus. iVeena is developing IVMED-85, a first in class, investigational eyedrop formulation for pediatric myopia. About Myopia Myopia, also known as nearsightedness, is a common eye condition where distant objects appear blurry while close objects can be seen clearly. It occurs when the eye grows too long from front to back, causing light to focus in front of the retina rather than directly on it. Myopia typically begins in childhood and tends to progress with age. If left unmanaged, it can increase the risk of serious eye complications later in life, including retinal detachment, glaucoma, and myopic macular degeneration. The global rise in myopia—particularly among children—has become a significant public health concern. * Lysyl oxidase (LOX) is a copper ion-dependent amino-acyl oxidase ** Clin Ophthalmol. 2018 Aug 29;12:1581–1587. doi:
Yahoo
3 days ago
- Business
- Yahoo
Kexing Biopharm's GB18 project received clearance of IND application from NMPA and FDA
SHENZHEN, China, May 28, 2025 /PRNewswire/ -- On May 26th, Kexing Biopharm ( announced that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for its independently developed innovative product, GB18. Moreover, GB18 has previously received the clearance from U.S. Food and Drug Administration (FDA) for IND application on May 21st. GB18 is an innovative biologic product developed for the treatment of cancer cachexia, a complication with a prevalence up to 40% to 70% among cancer patients. Currently, no specific biological therapies are available to address the condition, presenting vast market potential. Featuring a unique nanobody-Fc fusion molecular structure, the product demonstrates enhanced stability, bettered bioavailability, and significantly improved performance in inhibiting disease-associated signaling pathways. Benchmarking against globally leading pipelines with the same target (GDF-15) and indication, Kexing Biopharm's GB18 features a special nanobody-Fc fusion structure (VHH-Fc), with the patents granted or applied for the molecule globally already. Last October, a research article of GB18's preclinical study was published in the renowned international academic journal mAbs, which demonstrated that GB18 effectively alleviated weight loss in cancer cachexia models, showing superior weight recovery and improved muscle fibers in both quantity and size compared to the comparator. In cancer cachexia, the expression level of GDF-15 is significantly elevated, which is closely associated with tumor progression and the severity of cachexia. Therefore, targeting GDF-15 has emerged as a new strategy in addressing the clinical challenge of cancer cachexia. This recent FDA IND approval marks a significant milestone in the Company's globalization of innovative products. Approximately millions advanced cancer patients annually in the world are suffering from cachexia. There is a significant unmet clinical need for the indication of cancer Biopharm will remain steadfast in its mission to deliver "Precise Products, Predictable Effects, and Health Protection", with a focus on product quality and a commitment to scientific innovation, and improve the lives of patients worldwide. View original content: SOURCE Kexing Biopharm Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
4 days ago
- Business
- Yahoo
Enveric Biosciences Reports Positive Preclinical Results for Lead Drug Candidate EB-003
Statistically significant improvements in a preclinical model of severe chronic depression and despair Support for safe, extended, daily oral administration CAMBRIDGE, Mass., May 28, 2025--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, today announced positive preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a well-established psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions (statistical p-value < 0.01). These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. "We are encouraged by these statistically significant and biologically meaningful results in a severe chronic depression animal model," said Dr. Joseph Tucker, CEO of Enveric Biosciences. "EB-003 has now demonstrated strong behavioral efficacy and a clean safety profile in several animal models that are relevant to chronic treatment of severe depression. These data points validate the compound's pharmacological design and provide strong support for the planned Investigational New Drug (IND) application" EB-003 is the lead compound from Enveric's proprietary EVM301 Series, a pipeline of next-generation neuroplastogens engineered to stimulate synaptic plasticity without incurring hallucinogenic liability. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders. Leveraging its unique discovery and development platform Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric's lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit Forward-Looking Statements This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "proposes," "budgets," "explores," "schedules," "seeks," "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric's products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric's filings with the Securities and Exchange Commission, including Enveric's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on Contacts Investor RelationsTiberend Strategic Advisors, Inc. David Irish(231) 632-0002dirish@ Media RelationsTiberend Strategic Advisors, Inc. Casey McDonald(646) 577-8520cmcdonald@ Sign in to access your portfolio
