Founded in February 2013, Centrexion Therapeutics Corp. (NASDAQ: CNTX) is headquartered in Boston, Massachusetts, with 14 full-time employees (11/1/2018). It is a late-stage clinical biopharmaceutical company focusing on identification and development And commercialize new, non-opioid and non-addictive therapies to address the massive unmet medical needs for the treatment of chronic pain.
Centrexion Therapeutics Corp (CNTX):
According to 2011 data, more than 40 million adults in the United States and more than 1 billion people worldwide suffer from chronic pain every year. This disease pays a huge price in terms of direct treatment, rehabilitation expenses, reduced worker productivity, widespread opioid addiction, and emotional and financial burdens on patients and their families.
The World Health Organization (WHO) and the European Commission estimate that by 2050, the prevalence of osteoarthritis (OA) worldwide will affect 130 million people, of which 40 million will be severely disabled. According to a report from the Institute of Medicine of the National Academy of Sciences, pain is an important public health problem in the United States, causing social losses between 560 and 635 billion US dollars every year.
Although the pain problem is serious, there is basically no innovation in the development of treatment solutions. Since 2010, the US Food and Drug Administration (FDA) has only approved 19 pain treatment drugs, 11 of which are opioid variants, 1 is a slow-release generic corticosteroid, and 5 are aspirin variants , 2 kinds are other existing drug variants.
Centrexion Therapeutics Corp. is developing a series of new product candidates aimed at overcoming the limitations of current chronic pain treatment options and providing patients and doctors with better and safer treatment options.
Centrexion Therapeutics’ most advanced product candidate CNTX-4975 is designed to selectively and locally target and disrupt the signal transduction of pain-sensitive nerve fibers. CNTX-4975 is in a critical phase III development stage for the treatment of moderate to severe knee pain. In a phase II randomized, double-blind, placebo-controlled clinical trial of 175 patients with moderate to severe knee pain, the company observed that subjects who received a single intra-articular injection of 1.0 compared with placebo :
- There is a statistically significant and clinically significant reduction in pain when walking on flat ground.
- The pain began to ease the next day.
- Long-lasting pain relief, after one month of continuous treatment, pain relief for six months.
- Improvement of knee stiffness.
- Improve knee joint function.
- 24 hours after the IA injection, CNTX-4975 had no detectable systemic exposure.
In the first quarter of 2018, Centrexion Therapeutics began registering subjects in VICTORY-1, which is the first of the two key phase III registration trials of CNTX-4975 plans. It is expected to report first-line in the first quarter of 2020 result.
In the second half of 2018, Centrexion Therapeutics began recruiting OA-303 subjects, an open-label safety trial with approximately 850 subjects, and the second key CNTX-4975 Phase III registration trial-VICTORY-2, Including repeated administration. It is expected that OA-303 data will be reported in the second half of 2019 and the final results of VICTORY-2 will be reported in the second half of 2020.
If the results of these trials are positive, Centrexion Therapeutics plans to submit a new drug application (NDA) in the United States in the second half of 2021 and a marketing authorization application (MAA) in Europe.
CNTX-4975 was granted Fast Track designation by the FDA in January 2018 for the treatment of moderate to severe knee pain.
Centrexion Therapeutics Corp (CNTX) all product candidates and clinical development stages:
Centrexion Therapeutics Corp (CNTX) investment:
Centrexion Therapeutics Corp. (NASDAQ: CNTX) submitted its IPO prospectus on 10/19/2018, and plans to land on Nasdaq on 11/15/2018. The issue price is US$14.00-16.00, and 5 million shares will be issued. The fundraising will not exceed US$92 million, underwritten by BofA Merrill Lynch/ Leerink Partners/ Evercore ISI.