Primary Objective • To investigate the efficacy of treatment with oral Bionetide versus placebo in girls and women with Rett syndrome
Key Secondary Objective
• To investigate the efficacy of treatment with oral Bionetide versus placebo on ability to communicate in girls and women with Rett syndrome

Start Date15 Jun 2025

Sponsor / Collaborator

Biomed Industries, Inc.

NCT06732245

/ Not yet recruitingPhase 2

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]

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

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.

01 Dec 2024·Alzheimer's & Dementia

Phase 2 Clinical Trials of NA‐831 for the Treatment of Alzheimer’s Disease and Major Depressive Disorder, support the Neurogenesis Hypothesis

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

AbstractBackgroundAdult Hippocampal Neurogenesis has been shown to be involved in Major Depressive Disorder (MDD) and Alzheimer’s disease (AD) pathology. NA‐831 is a small drug molecule, exhibiting neuroprotection, neurogenesis and memory enhancing properties.MethodFor AD: A randomized clinical trial of NA‐831 was performed in 112 participants with mild and moderate Alzheimer’s disease (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 met the NIA‐AA core 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 criteria. MMSE: 17‐21.For MDD: A randomized, clinical study was conducted to investigate the efficacy and safety of two fixed doses (20 and 40 mg/d) of NA‐831 vs. that of placebo after 6‐week treatment in 32 adult patients with major depressive disorder (MDD).ResultFor AD: NA‐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. There were no serious adverse events observed.For MDD: The difference between active treatment and placebo of ∼7 points on the MADRS translates into a clinically relevant difference in response rates of 32.5% units, compared to an average of 16% units for antidepressants approved by the USA FDA. Treatment with NA‐831 for 6‐week was well tolerated and efficacious in reducing depressive and anxious symptoms in patients with MDD.ConclusionThe Neurogenesis Hypothesis has been shown to be a viable approach for further research for Alzheimer’s disease and Major Depressive Disorder. Phase 3 trials of NA‐831 for the treatment of AD and MDD are being conducted. Results of the clinical trials will be provided as soon as they are available.

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.

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 16 May 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

Phase 2 Clinical

Phase 3 Clinical

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

NA-931 ( GCGR x GIPR x GLP-1R x IGF-1R )	Obesity More	Phase 3 Clinical
NA-901(Biomed)	Depressive Disorder, Major More	Phase 3 Clinical
Traneurocin	Alzheimer Disease More	Phase 3
Bionetide	Rett Syndrome More	Phase 3
NA-941	Nonalcoholic Steatohepatitis More	Phase 2

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis