A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Oral NA-931, Alone or in Addition to Open Label Subcutaneous Tirzepatide , to Investigate the Efficacy and Safety in Overweight or Obese Men and Women

A phase 2 study to assess the efficacy of NA-931 alone or in addition to Tirzepatide to assess efficacy and safety in overweight or obese men and women

Start Date15 Mar 2025

Sponsor / Collaborator

Biomed Industries, Inc.

NCT06564753

/ RecruitingPhase 2

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 13-week Study of NA-931 for Weight Management in Subjects Who Are Obese or Overweight With at Least One Weight-related Comorbid Condition

This is a Phase 2 randomized, double-blind, placebo-controlled, parallel arm study of NA-931 in adults who are obese (BMI ≥30 kg/m2) or who are overweight (BMI ≥27 kg/m2) with at least one weight-related co-morbid condition.

Start Date19 Aug 2024

Sponsor / Collaborator

NeuroActiva, Inc.

[+1]

NCT06615700

/ CompletedPhase 1

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus

A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.

Start Date06 May 2024

Sponsor / Collaborator

Biomed Industries, Inc.

100 Clinical Results associated with Biomed Industries, Inc.

0 Patents (Medical) associated with Biomed Industries, Inc.

Literatures (Medical) associated with Biomed Industries, Inc.

01 Dec 2024·Alzheimer's & Dementia

Associations Between Alzheimer’s Disease and Obesity: Clinical Trials of NA‐831 for AD and NA‐931 for Obesity

Author: Tran, Lloyd ; Tran, Zung Vu ; Vu, Fern

AbstractBackgroundNA‐831 is a new drug candidate, exhibiting neuroprotection, neurogenesis and memory enhancing properties for the treatment of Alzheimer’s Disease (AD). NA‐931 is an analog of NA‐831, regulating the homeostasis of the triple: IGF‐1, GLP‐1 and GIP functions for obesity.MethodA randomized clinical trial of NA‐831 was performed in 112 participants with mild and moderate AD, half received the drugs and half received placebo. The patients with MCI received 10 mg of NA‐831 and patients with mild and moderate AD received 30 mg of NA‐831 or placebo orally per day. Subjects with MCI to meet the NIA‐AA core clinical criteria, CDR score of 0.5 and a Memory Box score of 0.5 or greater at Screening and Baseline. MMSE score ≥22. Subjects with mild & moderate AD to meet the NIA‐AA core clinical criteria. MMSE: 17‐21.Animal Studies of NA‐931: A 14‐day study in diet‐induced obesity DIO‐NASH mice was conducted to evaluate the treatment of NA‐931 on obesity.ResultNA‐831 showed a significant improvement for patients with mild and moderate AD with the ADAS‐Cog‐13 score change of an average of 4.1 as compared to the placebo after 24 weeks of treatment (p = 0.001; ITT). CIBIC‐Plus showed 78% patients improved (p = 0.01; ITT). mNA‐831 was well‐tolerated at 30 mg/day. It was observed that 66% (12 of 18) patients having diabetes amongst 56 patients on the NA‐831 drug treatment reported a loss of 17‐23% of body weight over 6 months. Only 4 of 7% of 56 patients on placebo reported a loss of 3‐5% over 6 months. There were no serious adverse events observed.The study in DIO‐NASH mice had demonstrated that treatment with NA‐931 resulted in significant reductions in body weight up to 26% (p<0.0001), as well as reductions in plasma glucose and plasma triglycerides up to 23% and 34%, respectively (p<0.003 for each). NA‐931can reduce the body mass index, without causing the muscle loss.ConclusionAn association of Alzheimer’s disease and diabetes obesity has been suggested with clinical results of NA‐831 and NA‐931. However, whether this association is causal requires further evaluation.

01 Dec 2024·Alzheimer's & Dementia

Phase 3 Clinical Protocol: Placebo‐Controlled, Double‐Blind, Parallel‐Group to Study Safety and Efficacy of NA‐831 in Combination with Lecanemab in Subjects with Early Alzheimer’s Disease

Author: Tran, Lloyd ; Tran, Zung Vu ; Vu, Fern

AbstractBackgroundLecanemab has been approved by the FDA for patients with early Alzheimer’s disease (AD). NA‐831 is an experimental drug that has showed a proof of safety and efficacy in Phase 2 clinical trial for patients with early Alzheimer’s disease.AD patients are treated with a number of comedications not only to address cognitive impairment (standard‐of‐care) but also other comorbidities. It has been shown that amyloid reduction at best leads to modest changes in clinical deterioration and that there is room for additional therapeutics to improve patient quality of life. In addition, amyloid‐related imaging abnormalities side‐effects need to be considered opening the possibilities of dose‐sparing with new combinations.MethodThe phase 3 study consists of a Core and Open Label Extension (OLE) Phase will be conducted to evaluate the efficacy and safety of combination therapy of NA‐ 831 and lecanemab with patients with Early Alzheimer’s Disease (EAD). The Core is an 18‐month treatment, multi‐centers, double blind, placebo controlled parallel group study.Enrollment: 600 participants. Ages: 50 to 90 Years. All sexes are eligible for study.Core Study:Participants will be divided in 3 groups, randomly assigned in a 1:1 ratio to receive a drug or a combination of two drugs or placebo.Group 1: will receive one 30 mg of NA‐831 capsule orally once a day or placebo,Group 2: will receive and intravenous lecanemab (10 mg per kilogram of body weight every 2 weeks) or placebo.Group 3: will receive one 30 mg of NA‐831 capsule orally once a day and intravenous lecanemab (5 mg per kilogram of body weight every 2 weeks) or placebo.Open Label Extension Phase: Participants completing the core study will receive one 30 milligram (mg) NA‐31 capsule orally once a day, and intravenous lecanemab (5 mg per kilogram of body weight every 2 weeks)ResultResults will be announced upon the completion of the Phase 3.ConclusionThe Phase 3 clinical trial will be conducted more than 30 sites in the US and several countries. The details of the Phase 3 methodology and protocol will be presented and discussed.

01 Dec 2024·Alzheimer's & Dementia

Amyloid hypothesis: 20 years of failure in Alzheimer’s research

Author: Tran, Lloyd ; Tran, Zung Vu

AbstractBackgroundWe reviewed the data of past failures to determine how aducanumab and lecanemab might differ from the rest of this class of drugs. Specifically, whether the differences between treatment and placebo are different.MethodWe systematically analyzed the data in publications where treatments were an anti‐Aβ monoclonal antibody drug, and data were available from published clinical trials. Only anti‐Aβ monoclonal antibody drugs that have completed at least a phase 2 trial were included. This class of drugs included, aducanumab, bapineuzumab, crenezumab, donanemab, gantenerumab, lecanemab, ponezumab, semorinemab, and solanezumab. We focused on two outcome measures that were most frequently reported ‐ CDR‐SB and ADAS‐Cog. Nearly all trials reported the post‐treatment difference between drug and placebo, i.e., the difference between scores of the treatment relative to the placebo at the end of the trial. On a scale where a higher score is “worse,” a negative (‐) difference “favors” treatment (lower score – higher score = ‐ value). We use bootstrapping methodology, a machine‐learning statistical procedure that resamples from a single dataset (with replacement) to create multiple samples. This resampling distribution allows for the calculation of means, median, standard errors, confidence intervals (CI), and other statistics. The means and 95%CI of these published differences were estimated by performing 10,000 resamples.ResultAll the clinical trials analyzed were randomized, placebo controlled. Sample sizes varied for the phase 3 trials, from 253 to 1072 per arm (median = 519 participants); trial lengths were from 76 to 105 weeks (median = 78 weeks). The estimated bootstrap mean and 95%CI for differences between placebo and drug, for CDR‐SB and for ADAS‐Cog were: CDR‐SB; mean (95%CI) = ‐0.08 (‐0.31 to +0.22), range of differences = ‐0.70 to 1.30; ADAS‐Cog; mean (95%CI) = ‐0.53 (‐1.03 to +0.22), range of differences = ‐1.60 to +4.74.ConclusionThe cumulative mean changes for CDR‐SB were ‐0.08; for ADAS‐Cog it was ‐0.53, with both 95%CI including zero. The score range for CDR‐SB is 0 to 18; the range for ADAS‐Cog is 0 to 70/90. These mean differences across the many trials conducted cannot be considered to be either clinically or statistically significant.

News (Medical) associated with Biomed Industries, Inc.

22 May 2023

·www.accesswire.com

Biomed Industries, Inc. Offers to acquire Neoleukin Therapeutics, Inc. (NASDAQ:NLTX)

SAN JOSE, CA / ACCESSWIRE / May 23, 2023 / Earlier today Biomed Industries, Inc. issued a letter to the Board of Directors of Neoleukin Therapeutics, Inc. (NASDAQ:NLTX). The letter described a proposal to acquire all the company's common stock for $1.60 per share which represents an 80% premium on the average price of $0.88 over the past 10 days, in which one share of Neoleukin will be exchanged for $1.00 in cash plus $0.60, or 0.075 share of Biomed Industries, Inc. As Neoleukin has 42,818,346 outstanding shares, Biomed's proposed offer has an enterprise value at $68.5 million. A full copy of the letter can be found below: CONTACT: Michael Willis Vice President of Biomed Industries, Inc. [email protected] May 24, 2023 To: The Board of Directors Neoleukin Therapeutics, Inc. 188 East Blaine, Suite 450 Seattle WA 98102 Donna Cochener Interim CEO Board Members: Martin Babler Cantey Boyd Erin Lavelle Dr. Sarah Noonberg Rohan Palekar Todd Simpson Dear Sir/Madame: Biomed Industries, Inc. is pleased to present a tender offer to acquire all the outstanding Common Stock of Neoleukin Therapeutics, Inc. ("Neoleukin" or the "Company") at $1.60 per share which represents an 80% premium on the average price of $0.88 over the past 10 days, in which one share of Neoleukin will be exchanged for $1.00 in cash plus $0.60 or 0.075 share of Biomed Industries, Inc. ("Biomed") Below is a brief summary of benefits of which a merger of Neoleukin and Biomed would add significant value for each of our respective businesses and shareholders: Biomed's Phase 2B and Phase 3 drug candidates for the treatment of Alzheimer's disease valued at approximately $600 million will increase the share price of the combined enterprise. A pathway to continue development of Neoleukin's current pipeline and to save considerable time and cost in recruiting and managing ongoing clinical trials of Neoleukin's drugs though Biomed's AI platform. We believe our offer is very compelling as it provides Neoleukin's shareholders with a highly certain and significant return and the ability to obtain liquidity for their shares, as well as the upside potential of Biomed. We can complete customary diligence and negotiate definitive documentation within 60 days. We believe our Proposal is in the best interests of all shareholders and believe it offers shareholders a significantly more attractive risk/reward scenario than the Board's current plan. Please be aware that this Proposal is an expression of interest only, and we reserve the right to withdraw or modify our Proposal in any manner. No legal obligation with respect to a transaction shall arise unless and until execution of mutually acceptable definitive documentation. Should you have any questions, please do not hesitate to contact us. We look forward to hearing from you. Sincerely, Lloyd L. Tran Chairman and CEO About Biomed Industries, Inc.: Biomed Industries, Inc.™ is a bio-pharmaceutical company committed to the development and commercialization of new drug therapeutics for unmet needs. Biomed Industries, Inc. is the parent company of Biomed Pharmaceuticals, Inc., NeuroActiva, Inc. and BiomedAI, Inc., Biomed Green LLC, Biomed Digital LLC. and MedAware Systems, Inc. Biomed's team has discovered a new family of drugs for the treatment and prevention of Alzheimer's disease. For more information, please contact Michael Willis Vice President of Business Development Biomed Industries, Inc. [email protected] www.biomedind.com SOURCE: Biomed Industries, Inc.

Phase 2

02 May 2023

·www.accesswire.com

Biomed Industries, Inc. Offers to Acquire Quince Therapeutics, Inc.

SAN JOSE, CA / ACCESSWIRE / May 3, 2023 / Earlier today Biomed Industries, Inc. issued a letter to the Board of Directors of Quince Therapeutics, Inc. (NASDAQ:QNCX). The letter described a proposal to acquire all the company's common stock for $2.50 pershare in cash and stock of Biomed Industries, Inc. A full copy of the letter can be found below: CONTACT: Michael Willis Vice President of Biomed Industries, Inc. [email protected] #### Biomed Industries, Inc. 2570 N. First Street, 2nd Floor San Jose, CA 95131 USA Tel. 800-824-5135 www.biomedind.com May 3, 2023 To: Quince Therapeutics 601 Gateway Boulevard, Suite 1250 South San Francisco, California 94080 The Board of Directors David Lamond Dirk Thye June Bray Margaret McLoughlin Una Ryan Christopher Senner Dear Sir/Madame: Biomed Industries, Inc. is pleased to submit this proposal (the "Proposal") as a tender offer to acquire all the outstanding Common Stock of Quince Therapeutics, Inc. ("Quince" or the "Company") we do not own for a price of $2.50 per share in cash and stock of Biomed Industries, Inc. ("Biomed"). Below is a brief summary of benefits of which a merger of Quince Therapeutics, Inc. and Biomed Industries, Inc. would add significant value for each of our respective businesses and shareholders: We believe our offer is very compelling as it provides Quince' shareholders with a highly certain and significant return and the ability to obtain liquidity for their shares, as well as the upside potential of Biomed. We can complete customary diligence and negotiate definitive documentation within 60 days. We believe our Proposal is in the best interests of Quince's shareholders as it offers your shareholders a significantly more attractive risk/reward scenario than the Board's current plan. Please be aware that this Proposal is an expression of interest only, and we reserve the right to withdraw or modify our Proposal in any manner. No legal obligation with respect to a transaction shall arise unless and until execution of mutually acceptable definitive documentation. Should you have any questions, please do not hesitate to contact us. We look forward to hearing from you. Sincerely, Lloyd L. Tran Chairman and CEO About Biomed Industries, Inc.: Biomed Industries, Inc.™ is a bio-pharmaceutical company committed to the development and commercialization of new drug therapeutics for unmet needs. Biomed Industries, Inc. is the parent company of Biomed Pharmaceuticals, Inc., NeuroActiva, Inc. and BiomedAI, Inc., Biomed Green LLC, Biomed Digital LLC. and MedAware Systems, Inc. Biomed's team has discovered a new family of drugs for the treatment and prevention of Alzheimer's disease. For more information, please contact Michael Willis Vice President of Business Development Biomed Industries, Inc. [email protected] https://www.biomedind.com SOURCE: Biomed Industries, Inc.

100 Deals associated with Biomed Industries, Inc.

100 Translational Medicine associated with Biomed Industries, Inc.

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Pipeline Snapshot as of 24 Jan 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Traneurocin	Alzheimer Disease More	Phase 3
NA-931 ( GCGR x GIPR x GLP-1R x IGF-1R )	Obesity More	Phase 2
NA-731	Brain Injuries, Traumatic More	Phase 2
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