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Hoth Therapeutics Announces the Selection of Altasciences for Manufacturing HT-TBI for Traumatic Brain Injury and Stroke
RELEASED AND WRITTEN BY HOTH THERAPEUTICS, INC.
NEW YORK, Sept. 20, 2022 /PRNewswire/ — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced it has signed an agreement with Altasciences, a fully integrated early phase CRO/CDMO, to develop and manufacture the HT-TBI drug product formulation. HT-TBI is being developed as a novel, point-of-care therapy for the treatment and/or prevention of secondary brain injury (e.g., brain edema and inflammation) resulting from ischemic stroke and traumatic brain injury ("TBI"). HT-TBI will be developed as a ready-to-use drug-device combination product for use in non-healthcare settings by patients and caregivers at risk for stroke/TBI, emergency healthcare professionals, and military personnel.
"We are pleased to have been selected by Hoth Therapeutics, Inc. to support their important goal of developing a ready-to-use drug-device combination product for the treatment and/or prevention of secondary brain injury. Altasciences' purpose is to help companies like Hoth Therapeutics research and develop potentially life-saving therapeutics—as safely and as fast as possible," stated Ben Reed, General Manager, CDMO Services at Altasciences.
"Hoth is excited to announce this partnership and next milestone in our development of HT-TBI," stated Dr. Stefanie Johns, Chief Scientific Officer. "We are leveraging Altasciences' expertise to develop and manufacture novel parenteral formulations to achieve a formulation that requires no preparation or special storage requirements to ensure HT-TBI can be used anywhere in the field at the time a head injury or stroke occurs."
The HT-TBI formulation development and manufacturing work by Altasciences will be used to support a future Investigational New Drug (IND) Application to initiate clinical trials.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.
About Altasciences
Altasciences is an integrated drug development company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, cGMP manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, cGMP manufacturing for clinical and commercial, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place undue reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms or the negative of those terms. Although Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U.S. Securities and Exchange Commission. All such statements speak only as of the date of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
- Xiong Y, Mahmood A, ChoppM. Current understanding of neuroinflammation after traumatic brain injury and cell-based therapeutic opportunities. Chin J Traumatol. 2018;21(3):137-151. doi:10.1016/j.cjtee.2018.0
SOURCE Hoth Therapeutics, Inc.
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ISSUE NO. 27 — The Complexities of Early-Phase Ophthalmic Drug Development
Ophthalmic medications have a particular set of challenges that can impact their speedy and successful path to market. From prototype formulation through preclinical testing, early-phase clinical and manufacturing and development, ophthalmic drug development presents with specific and unique complexities. It is best to entrust drug development to a partner with regulatory knowledge, technical expertise, and a thorough understanding of the market in this growing therapeutic area. From current reality to future trends, being at the forefront of ophthalmic drug development delivers tangible benefits to sponsors.
In Issue 27 of The Altascientist, we dive into all areas of ophthalmic drug development, including:
• Prototype development, formulation, and manufacturing
• Preparing for first-in-human studies
• Species and strain selection parameters
• Routes of administration
• Specialized ocular assessments and equipment
• bioanalysis
• Phase I clinical research
• Phase II to commercialization
Three case studies are also included!
Navigating the Complexities of Ophthalmic Drug Development
The global market for ophthalmic drugs was valued at USD 36.7 billion in 2020, according to Grandview Research. The compound annual growth rate (CAGR) is expected to be 6.4% from 2021 to 2028. The acceleration in market growth is influenced by increasing awareness of eye-related diseases and advancements in related technology. The aging of the population, as well as the impact of COVID-19 ocular involvement, are also contributing factors. Certain ocular diseases are quite rare, whereas others, such as cataracts, age-related macular degeneration (AMD), and glaucoma, are very common, especially in the aging population.
Drug development in the ocular space has specific challenges. The eye is a multi-faceted organism and has many barriers to drug delivery. Formulation and delivery options must be expertly planned and developed to overcome those barriers and ensure that the maximum bioavailability is achieved without negatively impacting vision or the physical structure of the eye. Planning of preclinical studies must consider the appropriate animal species for the route of administration and therapeutic area of the investigational drug. Some species are more appropriate for certain routes of administration, while others have relevant retinal mutations that can be leveraged in ocular development.
Clinical trials need to be carefully designed by knowledgeable specialists with significant ophthalmic experience. The delicate nature of the eye and the importance of subject safety are key considerations. Just as importantly, the bioanalysis of trial samples necessitates the use of bioanalytical techniques created especially for the often uncommon and frequently fragile matrices involved. Finally, understanding the regulatory environment and related guidances, as well as proactive and appropriate discussions with relevant agencies when warranted, are critical components of the pathway and can help ensure a seamless experience.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
Download publicationISSUE NO. 26 — CDISC Data Standards
The Clinical Data Interchange Standards Consortium (CDISC) is a worldwide organization for data standardization, ensuring that drug research data delivers the maximum value for sponsors, regulatory agencies, and patients. Data that is accessible, compatible, comparable across regions, and reusable for meta-analysis or reanalysis, serves to improve our understanding of human therapeutics by providing meaningful, efficient research data for the entire global drug research community. Implementing standards to collect, structure, and analyze data makes it easier to aggregate information and take advantage of big data.
In Issue 26 of The Altascientist:
• Introduction to standardization and its benefits
• Client considerations for nonclinical and clinical data standardization
• Case Study — Realized Efficiency
• Case Studies — Legacy Data Conversion
• The future of CDISC and data strategy
Why is Data Standardization in Drug Development Important?
There is tremendous value in standardizing and sharing data: organizations across the globe that are using CDISC standards produce faster, more efficient research, and pave the way for more breakthroughs that amplify the power of data, in both the short- and long-term.
“Adherence to data standards is integral to successful and efficient drug development for our clients,” says Nicole Maciolek, Vice President, Research Services, Medical Writing and Scientific Affairs, at Altasciences. “We are experts in applying CDISC standards, from preclinical SEND to clinical CDASH, SDTM, and ADaM. We are proud to be Gold members of the CDISC consortium, and to bring the advantages of standardization to all the data we deliver.”
Data that is presented in a well-organized, templated fashion is easier for regulatory reviewers to understand and interpret, which limits requests to sponsors for clarification or resubmission. The CDISC standards cover all types of data, from nonclinical to Phase III, across therapeutic areas, and are required for all studies supporting marketing authorization.
Sponsors benefit from data that is of high quality, easy to interpret, and leads to sound, swift go/no-go decisions. Regulatory bodies benefit from a smooth, consistent process that allows them to analyze all the data submitted in the same way, without concerns about the organization or interpretation of data that may be structured differently.
How Altasciences Ensures Compliance With CDSIC Data Standards
We ensure that our team is always up to date with the latest trends and guidelines in regard to CDISC standards. We utilize a suite of proprietary validation checks, as well as Pinnacle 21 Enterprise version technology, to load, review, and validate SDTM and ADaM data and Define.xml files. Our CDISC experts are available on a per-project or full-time equivalent (FTE) basis, according to your needs. Our team has converted data from clinical trials, in diverse therapeutic areas, to CDISC-compliant SDTM and ADaM datasets, as well as designed CDASH-compliant forms and databases for streamlined data management and reporting.
Click here to learn more about our clinical data management capabilities.
Explore all issues of The Altascientist in our Resource Center. And don’t forget to subscribe to “The Altascientist: Audiobooks” on Spotify, Apple Podcasts, or wherever you get your audio content.
Download publicationFive Reasons to Place Early-Phase Clinical Research in Canada
A well-planned clinical program designed to meet the regulatory requirements for the jurisdictions where you plan to request market authorization can be conduct