Full Press Release Details
NeuroSense Announces Third Quarter 2023 Financial
Results and Provides Business Update
Mass., November 28, 2023 -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments
for severe neurodegenerative diseases, today reported its financial results for the nine months ended September 30, 2023 and provided
"In early December, we look forward to reporting
topline clinical results from our Phase 2b ALS study. Additional data, including the biomarker results from our collaboration with Biogen
and primary biomarker endpoints are expected within the first half of 2024. We believe that positive results would offer substantial hope
to people living with ALS and would put PrimeC well on its path to a pivotal Phase 3 for regulatory approval," stated NeuroSense's
CEO, Alon Ben-Noon. "With a cash runway extending towards the end of Q2 2024, we believe we are well positioned, upon a positive
read out from the study, to advance our discussions with potential strategic partners."
Phase 2b Amyotrophic Lateral Sclerosis (ALS)
PARADIGM Trial Completed Double-Blind Segment
In November 2023, NeuroSense completed the 6-month
double-blind segment of PARADIGM, a placebo-controlled, multi-center Phase 2b clinical trial using a unique upgraded formulation of PrimeC,
which is designed to maximize the synergistic effect between the compounds in its combination drug. 96% of participants who completed
the double-blind segment of the trial chose to continue in the study and be treated with PrimeC through a 12-month open-label extension.
All participants who have completed the 18-month trial to date requested to continue treatment with PrimeC. NeuroSense supplies the drug
to the participants through an Investigator Initiated Trial (IIT) and will continue to provide PrimeC to any participant who completes
the trial and requests to stay on the Company's investigational ALS medication.
PARADIGM's secondary clinical endpoints
which are expected to be reported in December 2023 include: Amyotrophic Lateral Sclerosis Functional
Rating Scale-Revised (ALSFRS-R), Slow Vital Capacity (SVC), and overall survival to demonstrate an attenuation in disease progression.
NeuroSense also expects to report primary safety and tolerability results from the double-blind segment of the trial in December 2023.
U.S. FDA Confirmed CMC Strategy for PrimeC
Ahead of Pivotal Phase 3 for Commercial Readiness
NeuroSense recently concluded a successful Type
D meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of ALS. FDA Type D meetings are focused on a narrow
set of issues at key decision points to provide timely feedback critical to move a drug development program forward. The purpose of NeuroSense's
meeting with the FDA was to discuss PrimeC's chemistry, manufacturing, and controls (CMC) development plans in advance of an expected
Phase 3 pivotal study and potential subsequent marketing approval. The FDA agreed with NeuroSense's proposed CMC development plan, setting
the stage for a smooth progression with the production PrimeC for a Phase 3 and subsequent commercialization.
Non-Sponsored Study Demonstrated PrimeC's
Outstanding Effect on ALS Survival
At the Ichida Stem Cell Lab at University of Southern
California, PrimeC was shown to significantly increase the survival rate of induced motor neurons in an in vitro study utilizing
induced pluripotent stem cells (iPSCs) generated from people living with ALS. In another independent study carried out by Dr. Ichida in
an innovative iPSC model, PrimeC performed among the best in improving motor neuron survival when compared to two FDA approved ALS drugs
as well as several other ALS drugs in development. Together, these results reinforce previous findings on PrimeC's efficacy and
mechanism of action.
Phase 2 Alzheimer's Disease (AD) Trial Under
Preparation, First Patient Enrolled Expected in Q4 2023
NeuroSense published data from a biomarker study
which revealed elevated levels of novel biomarker TDP-43 in AD as compared to healthy controls in the first quarter of 2023. These results
demonstrate the therapeutic potential of NeuroSense's combination drug platform for AD. Currently, NeuroSense is preparing a Phase
2 double-blind proof-of-concept clinical study in AD. Regulatory submissions and site readiness have been ongoing during Q3 2023 and the
first patient enrolled is expected in December 2023.
Patents Granted in Europe, Japan, and Israel
for PrimeC Valid Through 2038
Patents have been granted in Europe, Japan, and
Israel for a key patent relating to "Compositions comprising an anti-inflammatory drug and a dicer activator for use in treatment
of neuronal diseases." These patents address NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, two FDA approved
drugs that are the active ingredients in PrimeC.
SME Status Received from European Medicines
Agency & NeuroSense Opens EU Office
The European Medicines Agency's (EMA) Small
and Medium-Sized Enterprise (SME) status offers NeuroSense regulatory guidance and engagement in dialogue with the EMA. The Company plans
to enroll patients at multiple sites across Europe in its planned Phase 3 pivotal ALS study of PrimeC. As Europe is a key market, in addition
to the U.S., NeuroSense opened an office in Ulm, Germany to lead its regulatory dialogue with the EMA and clinical operations during the
planned Phase 3 study.
As of September 30, 2023, NeuroSense
had cash of approximately $4.8 million.
In October 2023, the Company terminated its
previously established "at-the-market" ("ATM") equity offering program.
A summary of NeuroSense's unaudited consolidated
financial results is included in the tables below.
Amyotrophic lateral sclerosis (ALS) is an incurable
neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients
are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected
to grow 24% by 2040 in the U.S. and EU.
PrimeC, NeuroSense's lead drug candidate, is a
novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib.
PrimeC is designed to synergistically target several key mechanisms of amyotrophic lateral sclerosis (ALS) that contribute to motor neuron
degeneration, inflammation, iron accumulation and impaired RNA regulation to potentially inhibit the progression of ALS. PrimeC was granted
Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients
suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS),
Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with
limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on
strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple
formerly known as Twitter.
Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements,
other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained
in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate,"
"could," "estimate," "expect," "intend," "seek," "may," "might,"
"plan," "potential," "predict," "project," "target," "aim," "should,"
"will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements
contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent
uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing for release of results
from the double-blind segment of the Company's Phase 2b trial, the timing of enrollment of the first patient in the Phase 2
Alzheimer's disease study, the cash runway and regarding an expected Phase 3 pivotal study. Further, certain forward-looking statements
are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual
results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include
unexpected a delay in the reporting of results from PARADIGM clinical trial, the failure to meet the primary or secondary endpoints of
the trial, a delay in patient enrollment for a Phase 2 trial for Alzheimer's disease or its planned Phase 3 pivotal ALS trial of
PrimeC; incurrence of greater than anticipated expenses; the potential for PrimeC to safely and effectively target ALS; preclinical and
clinical data for PrimeC; the timing of current and future clinical trials, timing for reporting data; the development and commercial
potential of any product candidates of the company; and other risks and uncertainties set forth in NeuroSense's filings with the Securities
and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about
the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Annual Report on Form