NeuroSense Therapeutics has successfully completed a phase IIa clinical trial with their current combination drug PrimeC, illustrating the safety and tolerability of the pharmaceutical. Furthermore, initial signs of efficacy were observed as the overall disease decline was slower when compared to matched PRO-ACT placebo arm.

NeuroSense has also received a patent allowance in the US for PrimeC and expects to submit further patents based on clinical data.

NeuroSense Therapeutics has gained orphan drug designation for the Ciprofloxacin Celecoxib combination pharmaceutical, PrimeC, by the European Medicine Association (EMA). The classification compliments the prior orphan drug designation by the FDA in 2020. Additionally, NeuroSense was awarded a seal of excellence by the European Commission, illustrating the potential success of this drug.

NeuroSense co-founder and CEO Alon Ben-Noon was inspired to find an effective treatment for ALS after meeting with ALS patient Shay Rishoni. Alon founded NeuroSense with years of experience running a consulting firm that collaborated with several leading pharmaceutical companies. He was joined by an outstanding team of ALS specialists, with women making up 75% of the company.

 

Alon’s team began their research by studying pre-existing FDA-approved molecules that could target the main pathological pathways of ALS. After extensive research, they concluded that 2 molecules, Ciprofloxacin and Celecoxib, could potentially work synergistically to inhibit the progression of ALS. NeuroSense was contacted by entrepreneur Alon Gordon, who was inspired to find a cure after his wife was diagnosed with ALS. Gordon offered to fund NeuroSense’s research in an Israeli laboratory that specializes in drug screening with an ALS model of zebrafish, which have over 70% genetic similarity to humans. Additionally, the striking resemblance between the brains, immune systems, and nervous systems of humans and zebrafish makes zebrafish an ideal research model for ALS.

 

Following outstanding preclinical results, NeuroSense filed a patent and gained an Orphan Drug Designation from the FDA. Clinical studies began in Israel and the United States to evaluate the efficacy, safety, and tolerability of PrimeC. Due to promising preliminary results, NeuroSense hopes to bring PrimeC to the market within 4 years and is currently running fundraising campaigns. NeuroSense also hopes to use PrimeC to battle Alzheimer’s and Parkinson’s.

 

 

 

NeuroSense’s groundbreaking treatment, PrimeC, aims to regulate microRNA synthesis, reduce neuroinflammation, and affect iron accumulation. In preclinical studies in SOD1 and TDP-43 zebrafish mutant models, the treatment benefitted motor performance, motor neuron morphology, neuromuscular junction structure, and morphology of microglia cells.

Following the successful preclinical studies, NeuroSense initiated a 12-month open label clinical trial in 15 patients to determine the safety of PrimeC. The study also analyzed the efficacy of PrimeC by observing patients’ overall and respiratory functions. A virtual control group was used to predict each subject’s deterioration. Interim results of the study showed that patients taking PrimeC had a reduced deterioration in respiratory and overall function compared to the virtual control group, suggesting efficacy of PrimeC.

Following these preliminary results, NeuroSense plans to initiate a placebo-controlled clinical trial, which may lead to an NDA application.

NeuroSense Therapeutics has reported promising results from their NST002 Phase IIa clinical study. Patients at the Tel-Aviv Sourasky Medical Center received 9 months of treatment with PrimeC, after which positive trends in patients’ respiratory and overall function were observed, similar to the 6-month analysis results. In January 2021, the study will be concluded after 12 months of treatment. 

All participating patients have requested to continue with PrimeC treatment after the clinical study is completed.

Hear the people of NeuroSense discuss the science behind our drug, and present pre-clinical and preliminary clinical results.

 

Opening: 0:21

Introduction to NeuroSense’s Story: 3:40

PrimeC Mechanism of Action: 9:02

Pre-Clinical Results: 14:45

Pre-Clinical results summary: 24:56

PrimeC Unique Formulation: 26:57

Clinical Study NST002 Interim Top-Line Results: 29:14

Next Steps: 37:32

Q&A: 38:29

 

Avital Pushett is the head of the ALS clinical program at NeuroSense. When she was only 11 years old, Avital’s father was diagnosed with ALS. During the two years following his diagnosis, she watched her father lose his ability to function independently and unfortunately pass away from the disease. At NeuroSense, Avital has overseen clinical research in ALS patients in the United States and Israel. She is dedicated to finding a cure for ALS and is excited about the potential of PrimeC, which was not available during her father’s battle with ALS.

Dr. Shiran Zimri is the head of NeuroSense’s Scientific Program. Growing up, Shiran knew she wanted to pursue something that would bring positive change in the world, and her fascination with the brain led her to pursue a master’s and doctoral degree in neurobiology. She manages the scientific research at NeuroSense.

Avital and Shiran are committed to improving patients’ quality of life, and are confident that NeuroSense’s PrimeC will offer hope to those diagnosed with neurodegenerative diseases.

 

The interim results from PrimeC’s NST002 clinical trial indicated that treatment with PrimeC slowed disease progression in ALS patients, which highlights the exciting potential of this novel drug. The results were analysed using ALSFRS-R and vital capacity parameters. The 12-month study has monitored 15 patients with ALS over a period of 6 months and, in light of these promising results, is on track to continue for another 6 months. Additionally, Alon Ben-Noon announced that the company intends to initiate a double-blind clinical trial in 2021 to test the final combination of PrimeC.

 

PrimeC, developed by NeuroSense Therapeutics, has received an orphan drug status from the FDA. Since ALS is a rare disease, financial incentives are crucial to develop drugs profitably without assistance from the government. An orphan drug status allows manufacturers to benefit from market exclusivity, support from the FDA, tax exemptions and fee reductions.

 In preclinical studies, mutant and wild type zebrafish were treated with PrimeC, and the results demonstrated neuroprotection and a regained ability to swim. Following the positive outcomes, NeuroSense has begun two clinical trials with ALS patients based in Tel Aviv, Israel and Phoenix, Arizona. The ALS Functional Rating Scale Revised (ALSFRS-R) and other general assessments will be used to measure the progression of symptoms of ALS. All patients involved in the study will take PrimeC for 12 months, with patients in Tel Aviv taking a slightly higher dosage than those in the U.S. PrimeC is a combination of two drugs, Celecoxib and Ciprofloxacin, which work synergistically to target neuroinflammation and RNA metabolism pathologies.

NeuroSense is excited about PrimeC’s potential to help ALS patients.

 

The prospect of a viable treatment for ALS has inspired serial entrepreneurs – Yossi Gross and Ariel Gordon to play an active role in treating several neurodegenerative diseases. Both Yossi and Ariel have personally encountered the devastating effects of ALS, with Gross’ sister Shoshi and Gordon’s wife Eti having been diagnosed with it.

The sporadic and rapid onset of the disease, alongside the challenges of diagnosing ALS, has made a cure for this orphan disease incessant for Gross and Gordon. Gordon’s wife, Eti, is optimistic and hopeful that a treatment for ALS will be made available in the near future.

 

Amyotrophic Lateral Sclerosis (ALS) is a progressive neurodegenerative disease which affects nerve cells in the spinal cord and brainstem, causing loss of muscle control. There is currently no cure for this orphan disease, with 700 Israelis affected by ALS today. NeuroSense is ‘cautiously optimistic’ about their novel combination drug PrimeC, which is composed of two FDA approved pharmaceuticals (Ciprofloxacin and Celecoxib). These two compounds work synergistically to alleviate the symptoms caused by ALS. PrimeC targets multiple pathologies, mitigating the degeneration and inflammatory response of the motor neuron, and has significantly outperformed the current conventional medication, Riluzole, on a zebrafish model. The zebrafish model is often used for clinical testing, due to its similar genome sequence, optical transparency, and fast reproduction rate. NeuroSense is hoping to start clinical trials to determine whether PrimeC is able to slow down or entirely stop the progression of the disease in ALS patients.

Often large pharmaceutical companies neglect ALS due to the high barriers to entry alongside the relatively small market size. However, recent developments have been made in ALS research and NeuroSense hopes to improve the lives of patients suffering from this destructive disease.

 

Dr. Niva Russek-Blum is a neurobiologist and senior researcher at the Dead Sea and Arava Science Center and is committed to finding a cure for ALS. Over the past 5 years, she has been testing multiple drugs on ALS zebrafish models, hoping to find one that would halt the progression of ALS. Her prayers were answered in the form of PrimeC, NeuroSense’s development for ALS. Dr. Russek-Blum observed that the mobility of the zebrafish drastically improved when treated with NeuroSense’s drug, PrimeC.