SARASOTA, Fla. - Oragenics (NYSE:OGEN), Inc. (NYSE American: OGEN) revealed today that it has enhanced the formulation of its lead drug candidate, ONP-002, which is being developed to treat concussions through intranasal delivery. The company plans to initiate a Phase II clinical trial to evaluate the safety, feasibility, and effectiveness of the new chemical entity (NCE) by assessing patient blood biomarkers and functional outcomes.
The improved formulation is designed to increase the bioavailability of the neurosteroid, which Oragenics believes can enter the brain within minutes when administered intranasally. Achieving therapeutic levels of neurosteroids in the brain has traditionally been challenging due to solubility issues. Still, Oragenics asserts that its recent advancements have significantly raised the final dose levels and enhanced the drug's adhesion within the nasal cavity, thereby extending absorption times.
Dr. James Kelly, Chief Medical Officer at Oragenics, expressed optimism about the formulation's potential to reduce the duration and prevent long-term symptoms of concussions, which affect an estimated 69 million people worldwide annually.
Concussions, often resulting from falls, motor vehicle accidents, military incidents, and contact sports, can lead to severe neurological disorders and long-term disability in a significant portion of patients.
Oragenics is a biotechnology firm focused on the nasal delivery of pharmaceuticals for neurological disorders and the treatment of infectious diseases. Its portfolio includes candidates for mild traumatic brain injury and Niemann Pick Disease Type C, along with proprietary intranasal formulations and delivery devices.
The company's forward-looking statements indicate a commitment to advancing the development of its product candidates, including undergoing regulatory processes and clinical trials. However, they caution that these statements are subject to various risks and uncertainties that could impact the actual results.
This announcement is based on a press release statement from Oragenics, and no further information about the Phase II clinical trial's specific start date or the detailed results of the formulation improvement has been disclosed. The company's progress will likely be monitored by investors and medical professionals interested in the latest treatments for concussion and other neurological conditions.
In other recent news, Oragenics, Inc. has been making significant strides in its neurological treatment platform. The company has completed a prototype for an automated intranasal device, designed to administer medication to patients who have suffered a concussion. The device is planned to be used in the upcoming Phase II trial of Oragenics' lead drug candidate, ONP-002, which targets the brain by delivery through the nasal cavity.
Oragenics has also gained approval for its compliance plan by the NYSE American. This plan is aimed at rectifying the issues that led to non-compliance with the exchange's listing standards. The company will undergo quarterly reviews to ensure adherence to the compliance plan.
The company recently appointed Dr. William Frank Peacock as Chief Clinical Officer. Dr. Peacock, with his extensive experience in emergency medicine research, will oversee the upcoming Phase II clinical trial of ONP-002. The Phase II trial follows a successful 40-patient Phase I study that found ONP-002 to be safe and well-tolerated.
Oragenics has also established a subsidiary in Australia to capitalize on research and development rebates provided by the Australian government. The company has contracted with Avance Clinical, a Contract Research Organization, for the Phase II study of ONP-002. These developments reflect Oragenics' continued commitment to advancing its product portfolio and strategic endeavors to create long-term value.
InvestingPro Insights
As Oragenics, Inc. (NYSE American: OGEN) endeavors to revolutionize concussion treatment with its lead drug candidate, ONP-002, the company's financial health and market performance provide a broader context for investors.
According to recent data from InvestingPro, Oragenics has faced significant challenges. The company's revenue for the last twelve months as of Q1 2024 stood at a mere $0.02 million, accompanied by a dramatic revenue decline of 84.54% compared to the previous period. Moreover, the gross profit margin has been deeply negative at -70099.44%, indicating substantial costs outweighing revenue.
Reflecting on the market sentiment, Oragenics has not been immune to struggles, with the stock experiencing a steep 6-month price total return of -81.57%, which aligns with a broader downward trend over the past year. The InvestingPro Tips for Oragenics highlight that, despite the company's innovative pursuits in the pharmaceutical industry, it suffers from weak gross profit margins and has not been profitable over the last twelve months. The stock has fared poorly over the last month, with a total return of -36.56%, emphasizing the bearish outlook from investors.
Still, there are additional InvestingPro Tips available that could offer further insights into Oragenics' potential and industry standing. With a total of 12 tips available on InvestingPro, investors can gain a more comprehensive understanding of the company's financial health and market performance. Interested individuals can use the coupon code PRONEWS24 to receive up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, providing access to valuable investment analysis and metrics.
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