Eupraxia Pharmaceuticals Enters Collaborative Partnership with NBCD for Lead Osteoarthritis (OA) Product Candidate
- NBCD (Nordic Bioscience Clinical Development) to make strategic investment on the same terms of Eupraxia's recently completed IPO
VICTORIA, BC, April 14, 2021 /CNW/ - Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced that it has entered into an agreement (the "CTO Agreement") with NBCD A/S ("NBCD"), a contract research organisation dedicated to clinical drug development and research in OA, to conduct Eupraxia's EP-104IAR Phase 2 clinical trial that will initiate later this year.
Pursuant to the CTO Agreement, NBCD has also agreed to make a US$500,000 investment in Eupraxia (the "Equity Investment") on the same terms as Eupraxia's recently completed initial public offering, as further detailed below. NBCD's subscription for the Equity Investment will be satisfied by setting off US$500,000 of service fees otherwise payable by Eupraxia to NBCD under the CTO Agreement and allows Eupraxia to expand enrollment in its EP-104IAR Phase 2 clinical trial.
Eupraxia's Phase 2 study is a placebo-controlled, double-blind, randomized trial evaluating the efficacy and safety of EP-104IAR in 300 patients with knee OA. NBCD will initiate the trial at three clinical research centres in Denmark with a proven track record in osteoarthritis clinical trials, with results expected in the fourth quarter of 2022. NBCD also maintains a global operational footprint, allowing Eupraxia to expand current and future trials into the United States and other geographies.
"NBCD is a strong clinical trial partner with a global reputation in the OA space," said James A. Helliwell, MD, Chief Executive Officer of Eupraxia. "NBCD's investment allows us to increase our Phase 2 enrollment, which we expect will provide a more robust understanding of the long-term pain relief potential of our drug."
Jeppe Ragnar Andersen, CEO of Copenhagen-based NBCD and Sanos Group, commented: "This is an important step in our partnership with Eupraxia, and demonstrates our conviction in EP-104IAR's potential to meet the significant unmet medical need and market demand for long-lasting pain relief for knee osteoarthritis."
The Phase 2 trial will randomise patients to receive a single injection of 25 mg EP-104IAR or placebo and measure pain relief out to a maximum of six months. Originally planned for 240 patients, Eupraxia estimates that with the combination of savings associated with using dedicated clinical research sites in Denmark, and the Equity Investment, the expanded 300-patient trial costs will remain consistent with the original budget.
Recruitment of the additional 60 patients is expected to extend the time to data readout for the Phase 2 trial by approximately eight weeks.
About the Equity Investment
NBCD will make the US$500,000 Equity Investment on the same terms as the Company' initial public offering, which closed on March 9, 2021. NBCD's subscription for the Equity Investment will be satisfied by setting off US$500,000 of service fees otherwise payable to NBCD by Eupraxia pursuant to the CTO Agreement described above.
Under the Equity Investment, the Company will issue to NBCD 78,456 units of the Company (the "Units") at a price of C$8.00 per Unit (converted into US dollars using the Bank of Canada exchange rate on April 12, 2021). Each Unit will consist of one common share in the capital of the Company and one-half of one common share purchase warrant of the Company (each whole common share purchase warrant, a "Warrant"). Each Warrant will be exercisable into one common share of the Company (each, a "Warrant Share") at an exercise price of $11.20 per Warrant Share at any time prior to 5:00 p.m. (Toronto time) on the date that is five years from the date of issuance, subject to adjustment in certain events. The Warrants will include an acceleration provision, exercisable at the Company's option, if the Company's daily volume weighted average share price is greater than $22.40 for five consecutive trading days. The Warrants will be transferable but will not be listed on the Toronto Stock Exchange (the "TSX").
The Equity Investment remains subject to the approval of the TSX.
About EP-104IAR
Eupraxia's lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting pain relief for knee osteoarthritis (OA). The U.S. Centers for Disease Control and Prevention estimates that knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer with knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can greatly affect quality of life.
With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. Current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for the treatment of knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration but can expose the body to unwanted local and systemic side effects.
EP-104IAR endeavours to provide long-term pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane.
Injected into the knee, EP-104IAR is intended to slowly release drug at therapeutic concentrations for up to six months. This has the potential dual advantage of providing long-duration pain relief with fewer systemic side effects. An enhanced safety profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees.
EP-104IAR has completed a Phase 1 trial and is currently in Phase 2 clinical development. A modified version of EP-104IAR is under development for canine and equine OA.
About NBCD
NBCD is a Contract Research Organization (CRO) dedicated to clinical drug development and research in osteoarthritis. NBCD specializes in design and execution of clinical trials within both pain and Disease-Modifying Osteoarthritis Drugs (DMOAD) compounds for osteoarthritis. NBCD are experts in placebo response mitigation and osteoarthritis study design. NBCD supports their biotech and pharmaceutical clients in advancing osteoarthritis compounds through all clinical development phases.
NBCD has more than 25 years of experience in osteoarthritis biomarkers and clinical trials. Combining the background in preclinical research and clinical research enables NBCD to help provide a faster and smarter evaluation the potential clinical viability of drug candidates.
For further details about NBCD, please visit the Company's website at: www.nbcd.com
About Eupraxia
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia's product candidates has the potential to address therapeutic areas with high unmet medical need, and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.
In addition to Eupraxia's lead product candidate, EP-104IAR, Eupraxia is developing a pipeline of earlier-stage long-acting formulations. Potential pipeline candidates include a range of drugs for indications such as post-surgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. Eupraxia is also developing a formulation of EP-104IAR for use in canine and equine osteoarthritis.
For further details about Eupraxia, please visit the Company's website at:
Notice Regarding Forward-looking Statements and Information:
This news release includes forward-looking statements and forward–looking information within the meaning of Canadian securities laws. Often, but not always, forward–looking information can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Forward looking statements in this press release include statements regarding the Company's plans, focus and objectives, the potential and benefits of Eupraxia's product candidates, including EP-104IAR, the results, timing and cost of the Company's Phase 2 trial and completion of the Equity Investment, including TSX approval thereof. Such statements and information are based on the current expectations of Eupraxia's management, and are based on assumptions and subject to risks and uncertainties. Although Eupraxia's management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward–looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including the risk factors set forth under the heading "Risk Factors" in the Company's final long-form prospectus dated March 3, 2021 and which is available on SEDAR at www.sedar.com. Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward–looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward–looking statement or information can be guaranteed. Except as required by applicable securities laws, forward–looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward–looking statement or information, whether as a result of new information, future events or otherwise.
SOURCE Eupraxia Pharmaceuticals Inc.
