Chromocell Announces Unveiling of Injectable Depot Program for the Treatment of Surgical Pain
Chromocell Therapeutics (NYSE American: CHRO) has unveiled an injectable depot program using peripheral nerve blocks for post-operative pain treatment. The program leverages the company's NaV1.7 molecule, targeting a market of approximately 700,000 total knee replacements and 500,000 shoulder arthroplasties performed annually in the US. The company's drug has shown no addictive properties in four Phase I trials and demonstrated strong efficacy in preclinical models. The program aims to reduce opioid usage and could benefit from NOPAIN Act provisions upon FDA approval.
Chromocell Therapeutics (NYSE American: CHRO) ha svelato un programma di depot iniettabile che utilizza blocchi nervosi periferici per il trattamento del dolore post-operatorio. Il programma sfrutta la molecola NaV1.7 dell'azienda, mirando a un mercato di circa 700.000 sostituzioni totali del ginocchio e 500.000 artroplastiche della spalla effettuate annualmente negli Stati Uniti. Il farmaco dell'azienda non ha mostrato proprietà addictive in quattro studi di fase I e ha dimostrato una forte efficacia in modelli preclinici. Il programma mira a ridurre l'uso di oppioidi e potrebbe beneficiare delle disposizioni del NOPAIN Act dopo l'approvazione della FDA.
Chromocell Therapeutics (NYSE American: CHRO) ha presentado un programa de depósito injectable que utiliza bloqueos nerviosos periféricos para el tratamiento del dolor postoperatorio. El programa aprovecha la molécula NaV1.7 de la empresa, apuntando a un mercado de aproximadamente 700,000 reemplazos totales de rodilla y 500,000 artroplastias de hombro realizadas anualmente en EE. UU. El fármaco de la empresa no ha mostrado propiedades adictivas en cuatro ensayos de fase I y ha demostrado una fuerte eficacia en modelos preclínicos. El programa busca reducir el uso de opioides y podría beneficiarse de las disposiciones de la Ley NOPAIN tras la aprobación de la FDA.
크로모셀 테라퓨틱스 (NYSE American: CHRO)는 수술 후 통증 치료를 위해 말초 신경 차단을 사용하는 주사형 약물 프로그램을 발표했습니다. 이 프로그램은 회사의 NaV1.7 분자를 활용하여 매년 미국에서 약 70만 건의 총 무릎 교체 및 50만 건의 어깨 관절 성형 수술 시장을 목표로 합니다. 회사의 약물은 4개의 1상 시험에서 중독성이 없음을 보여주었고, 전임상 모델에서도 강력한 효능을 입증했습니다. 이 프로그램은 오피오이드 사용을 줄이는 것을 목표로 하며 FDA 승인 후 NOPAIN 법의 혜택을 받을 수 있습니다.
Chromocell Therapeutics (NYSE American: CHRO) a dévoilé un programme injectable déposé utilisant des blocs nerveux périphériques pour le traitement de la douleur postopératoire. Le programme exploite la molécule NaV1.7 de l'entreprise, ciblant un marché d'environ 700 000 remplacements totaux de genoux et 500 000 arthroplasties de l'épaule effectués chaque année aux États-Unis. Le médicament de l'entreprise n'a montré aucune propriété addictive lors de quatre essais de phase I et a démontré une forte efficacité dans des modèles précliniques. Le programme vise à réduire l'utilisation d'opioïdes et pourrait bénéficier des dispositions de la loi NOPAIN après approbation de la FDA.
Chromocell Therapeutics (NYSE American: CHRO) hat ein injizierbares Depotprogramm vorgestellt, das periphere Nervenblockaden zur Behandlung von postoperativen Schmerzen nutzt. Das Programm nutzt das NaV1.7-Molekül des Unternehmens und zielt auf einen Markt von etwa 700.000 totalen Kniegelenkersatzoperationen und 500.000 Schulterarthroplastiken, die jährlich in den USA durchgeführt werden. Das Medikament des Unternehmens hat in vier Phase-I-Studien keine süchtig machenden Eigenschaften gezeigt und hat eine starke Wirksamkeit in vorklinischen Modellen demonstriert. Das Programm zielt darauf ab, den Gebrauch von Opioiden zu reduzieren und könnte von den Bestimmungen des NOPAIN-Gesetzes nach der FDA-Zulassung profitieren.
- Drug showed no addictive properties in four Phase I trials
- Large potential market of 1.2M annual surgical procedures in the US
- Strong efficacy demonstrated in preclinical models
- Potential benefits from NOPAIN Act provisions
- Product still in early development phase
- No FDA approval yet
Insights
The unveiling of Chromocell's injectable depot program represents a significant strategic expansion in the non-opioid pain management space. The program leverages their NaV1.7 molecule, which has already demonstrated promising results in four Phase I trials with no dose-limiting tolerability issues. The target market is substantial, with 1.2 million combined knee and shoulder surgeries annually in the US.
The focus on NaV1.7 channels is particularly noteworthy due to its strong genetic validation in pain treatment. Clinical evidence from Erythromelalgia patients provides robust support for NaV1.7's role in pain signaling. If successful, this could offer a non-addictive alternative to opioids for post-operative pain management, potentially qualifying for NOPAIN Act benefits, which would enhance market adoption.
The commercial potential for Chromocell's injectable depot program is compelling, targeting a significant market opportunity in post-operative pain management. The 700,000 knee replacements and 500,000 shoulder arthroplasties annually represent a substantial addressable market. The program's strategic alignment with the NOPAIN Act could provide favorable reimbursement pathways and accelerate market penetration.
The company's approach of leveraging existing IP and research data for multiple applications demonstrates efficient resource utilization and potential for multiple revenue streams. The non-addictive profile, combined with demonstrated safety in Phase I trials, positions the product favorably in the current healthcare landscape focused on reducing opioid dependence.
FREEHOLD, N.J., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Chromocell Therapeutics Corporation (“Chromocell”, or the “Company”), (NYSE American: CHRO), a pioneer in the development of non-opioid pain treatment therapeutics, today announced the unveiling of its injectable depot program utilizing peripheral nerve blocks for the treatment of post-operative pain. The depot program is based on the Company’s novel NaV1.7 molecule for treating chronic pain and eye pain.
There are approximately 700,000 total knee replacements and 500,000 shoulder arthroplasties performed annually in the Unites States for which this analgesic modality might be applicable, providing a robust potential market for the product.
“We are leveraging our existing know-how and intellectual property to target different pain indications and methods of delivery in an efficient and synergistic manner. We are taking advantage of the extensive pre-clinical and Phase I studies performed with CC8464 demonstrating strong efficacy in a wide variety of preclinical models and no dose limiting tolerability concerns in four Phase I trials,” said Frank Knuettel, Chief Executive Officer.
Eric Lang, Chief Medical Officer further commented, “Of the various sodium channel targets, NaV1.7 is the most genetically validated for the treatment of pain. The over expression of NaV1.7 activity leads to Erythromelalgia, one of the most severe types of pain described in humans, whereas over expression of NaV1.8 leads to mild-moderate pain. We anticipate that our injectable depot program utilizing peripheral nerve blocks for the treatment of post-operative pain could be an excellent and potent analgesic.”
The Company believes there are strong synergies between the programs and is building a suite of related products to address multiple different types of pain and methods of delivery, with a drug that has shown no addictive properties in 4 Phase I trials. With these programs, the Company hopes to reduce usage of opioids and other sub-optimal drugs in various indications and expects to be able to take advantage of certain NOPAIN Act provisions if the drugs are approved by the FDA.
About Chromocell
Chromocell Therapeutics Corporation is a clinical-stage biotechnology company focused on developing and commercializing novel, non-opioid, non-addictive therapeutics to alleviate pain. The Company’s initial clinical focus is to selectively target the sodium ion-channel known as NaV1.7 for the treatment of various types of chronic neuropathic pain and acute and chronic eye pain. For company updates and to learn more about Chromocell, visit www.chromocell.com or follow us on social media.
Forward-Looking Statements
This press release contains forward-looking statements regarding the Company’s current expectations. These forward-looking statements include, without limitation, references to the Company’s expectations regarding (i) the amount of shares of Common Stock to be repurchased under the Repurchase Plan, if any, (ii) the Company’s belief that its Common Stock is undervalued, (iii) the Company’s belief that its Common Stock is an attractive investment at its current price, (iv) the Company’s ability to conduct repurchases in accordance with applicable laws and regulations, (v) our ability to enhance stockholder value and (vi) the impact of laws and regulations. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ materially from those set forth in such forward-looking statements include, but are not limited to, risks and uncertainties related to there being no guarantee that the trading price of the Company’s Common Stock will be indicative of the Company’s value or that the Company’s Common Stock will become an attractive investment in the future. These and other risks and uncertainties are described more fully in in our filings with the U.S. Securities and Exchange Commission. The information in this press release is provided only as of the date of this press release, and we undertake no obligation to update any forward-looking statements contained in this press release based on new information, future events, or otherwise, except as required by law.
For Investor Inquiries:
Mike Moyer
Managing Director, LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
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