相关临床试验
6
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
1996
进行中（未招募）
3
50.0%
尚未招募
1
16.7%
终止
1
16.7%
Unknown
1
16.7%
暂无批准数据
- Oragenics is preparing for Phase 2a clinical trials in Australia for ONP-002, a potential first-in-class treatment for concussion and mild traumatic brain injury. - The company's proprietary intranasal delivery platform enables targeted, non-invasive delivery of therapeutics directly to the brain for neurological disorders. - Concussion and mild traumatic brain injury represent conditions with significant unmet medical need and no FDA-approved therapies currently available. - Following Australian trials, the company plans to conduct U.S. Phase 2b trials for ONP-002.
- Oragenics, a clinical-stage biotechnology company, has formed a strategic partnership with Receptor.AI to leverage artificial intelligence for identifying and developing neurological therapeutics targeting brain health conditions. - The collaboration will use AI computational models to predict optimal receptor binding profiles for novel compounds acquired by Oragenics in 2023, potentially accelerating laboratory validation and expanding beyond their lead candidate ONP-002. - The partnership aims to address multiple neurological and psychiatric indications including Alzheimer's disease, Parkinson's disease, PTSD, opioid addiction, and anxiety disorders through Oragenics' proprietary intranasal delivery platform. - This strategic move represents Oragenics' evolution from a single-asset company focused on concussion treatment to a diversified neurological therapeutics developer while maintaining capital efficiency.
- Oragenics completed a $20 million preferred stock offering to fund ongoing ONP-2 concussion clinical trials and related research and development activities. - The biotechnology company focuses on developing intranasal pharmaceuticals for neurological disorders, including treatments for mild traumatic brain injury (mTBI). - The offering includes 800,000 shares of Series H Convertible Preferred Stock at $25 per share, convertible to common stock at $2.50 per share. - Proceeds will also support repayment of a $3 million bridge note and general corporate purposes as the company advances its neurology pipeline.
- Oragenics has submitted an Investigator's Brochure for Phase II clinical trial of ONP-002, a novel intranasal neurosteroid targeting mild traumatic brain injury treatment in Australia. - The drug candidate demonstrated promising preclinical results in reducing inflammation, oxidative stress, and brain swelling, with Phase I studies confirming safety in healthy adults. - The upcoming Phase II trial will evaluate acute intranasal administration in concussion patients, focusing on cognitive testing, visual motor assessment, and biomarker analysis.
- Oragenics and BRAINBox Solutions have formed a strategic partnership to create the first comprehensive concussion management platform, combining diagnostic biomarkers with intranasal therapy ONP-002. - The collaboration integrates BRAINBox's AI-driven diagnostic platform using neurological biomarkers and assessments with Oragenics' intranasal therapeutic candidate for improved concussion care. - Initial clinical results show promise, with ONP-002 demonstrating good tolerability in Phase I trials, while addressing a significant market need of over 5 million annual concussion cases in the US alone.
- Oragenics is set to begin Phase II clinical trials in Australia for ONP-002, a treatment for mild traumatic brain injury, with first patient dosing aimed for late Q1 or early Q2 2025. - The company has improved ONP-002's formulation and intranasal delivery device, completing a spray-dry campaign to ensure sufficient drug supply for the trials. - Janet Huffman has been appointed as interim CEO, bringing extensive experience in healthcare finance to guide Oragenics through its next phase of development. - Oragenics plans to submit an Investigational New Drug (IND) package for Phase IIb clinical trials in the United States by Q3 2025, expanding its clinical development program.
- Oragenics Inc. terminated its President's employment agreement, as disclosed in a recent SEC filing, marking a significant leadership change. - The company entered a sales agreement for an at-the-market offering of common stock, potentially raising up to $10 million. - Oragenics' ONP-002, a concussion treatment candidate, passed FDA-required safety tests and is advancing towards Phase II trials. - Recent appointments of Dr. Peacock and Dr. Kelly as Chief Clinical Officer and Chief Medical Officer, respectively, will oversee the Phase II trial.
- Oragenics' ONP-002, a neurosteroid delivered intranasally, is advancing to Phase II clinical trials for treating moderate to severe concussions. - Pre-clinical studies demonstrated ONP-002's cardiac safety and non-genotoxicity, alongside successful completion of an FDA-recognized intranasal casting study. - The Phase II trial will assess ONP-002's efficacy in reducing concussion symptoms and improving functional recovery, with initial studies planned in Australia. - Oragenics has secured approximately $6 million in funding to support the advancement of ONP-002 through Phase II clinical trials.
