- Full data of Phase I single-ascending dose safety and tolerability study of CT-044 expected in mid-2020
- Teresa Byrne joins as Director of Clinical Operations
DALLAS, TX / ACCESSWIRE / April 15, 2020 / CerSci Therapeutics ("CerSci"), a clinical-stage pharmaceutical company developing a portfolio of non-opioid, non-addictive treatments for pain relief, announced today a development update related to its novel product candidate CT-044, the clinical impact of the COVID-19 coronavirus pandemic and the addition of Teresa Byrne to the CerSci executive team as Director of Clinical Operations.
CerSci is currently developing CT-044, a non-metal based, orally bioavailable, small molecule Radical Species Decomposition Accelerant (RSDAx) of peroxynitrite and hydrogen peroxide, for the treatment of acute and chronic pain, including acute post-surgical pain and painful diabetic neuropathy.
Clinical Development Update
In June and December of 2019, CerSci initiated Phase I human safety and tolerability studies of CT-044. The primary objective of the Phase I studies was to investigate the safety and tolerability of CT-044 in healthy volunteers. The single-ascending dose (SAD) study was initiated in June 2019 and consisted of four cohorts of eight subjects each, with cohorts receiving a 150mg, 450mg, 1100mg, or 2000mg oral dose of CT-044. Dosing was completed in November 2019.
The multiple-ascending dose (MAD) study was initiated in December 2019. The study consists of three cohorts of eight subjects each, with cohorts receiving three doses per day of 200mg, 400mg, or 600mg. To date, CerSci has completed enrollment and dosing of two of the three cohorts. Due to the current COVID-19 pandemic, CerSci has paused the enrollment of the third cohort. When appropriate, CerSci will begin enrolling and dosing the final cohort.
In addition, CerSci has completed dosing for a food effect study of CT-044 on ten volunteers in both fed and fasted states.
Full results from the SAD and food effect studies are currently expected in mid-2020.
Once CerSci has completed all required Phase 1 studies, the company plans to proceed with proof-of-concept Phase 2 trials.
Impact of COVID-19
CerSci is currently monitoring the impacts of COVID-19 at its clinical sites with a focus on ensuring the continuing safety and wellbeing of study participants.
To date, COVID-19 has had a manageable impact on the clinical development of CT-044. The ultimate impact of the pandemic on CerSci's business, however, remains uncertain and subject to future developments, including the duration of the pandemic, the ultimate spread of the disease and new information that may emerge.
"Dosing of our final cohort of our MAD Phase 1 study has been postponed as the health and safety of our employees, healthcare workers, and subjects are our highest priority at this time," said Dr. Lucas Rodriguez, Chief Executive Officer of CerSci Therapeutics. "During this period, we continue to execute our fundraising strategy as well as discuss the potential of initiating our Phase 2 studies of CT-044. We remain committed to completing all necessary Phase 1 studies and advancing to Phase 2 proof-of-concept and efficacy studies. Our ultimate goal is to get this technology in the hands of the patients and caregivers who are desperate for alternatives to opioid pain relief."
Executive Team Expansion
In March, Teresa Byrne joined the company as Director of Clinical Operations. Teresa will help lead and execute CerSci's clinical and regulatory strategy as the company progresses in the development of CT-044 for acute and chronic pain indications.
CerSci Chief Medical Officer, Dr. Marco Pappagallo, reports "Our ongoing safety studies are currently on track to complete dosing and we are pleased with our blinded top-line data to date. We believe we are in a strong position to continue our development into Phase 2 and we are very pleased and excited that Teresa has joined our team. She brings expertise and horsepower necessary to continue pushing this asset towards commercialization."
About CerSci Therapeutics
CerSci is a clinical-stage pharmaceutical company developing non-opioid analgesic drug products without the deleterious side effects (e.g., abuse liability, cognitive impairment, respiratory depression, etc.) of many current pain treatments on the market. CerSci's novel clinical candidate, CT-044, is designed as an orally bioavailable compound that will initially target post-operative and chronic neuropathic pain indications.
Forward-Looking Statements
This press release contains forward-looking statements that are based on management's beliefs and assumptions and on information currently available to management. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the clinical progress of our product candidate. These forward-looking statements include information about possible or assumed future results of our business, financial condition, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. Forward-looking statements are based on information we have when those statements are made or our management's current expectation and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change, including related the effects of the COVID-19 (coronavirus) pandemic. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Investor Relations Contact:
Chiara Russo
Solebury Trout
617-306-9197
crusso@troutgroup.com
www.CerSci.com
SOURCE: Solebury Trout
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