SpliSense Overview
SpliSense is a clinical stage company developing transformative RNA-based treatments for unmet needs relating to diverse pulmonary diseases. Its treatment is based on clinically validated Antisense Oligonucleotide (ASO) technology, delivered non-invasively by inhalation to the lungs. The company is focused on a variety of innovative therapies, in different development stages from discovery to IND. Using an innovative approach, SpliSense aims to target the root cause of the disease, to overcome specific genetic mutations and modulate proteins expression and function. The company recieved FDA approval for its lead ASO product, SPL84, for the treatment of patients with cystic fibrosis.
Cumulative Funding Raised Over Time ($)
$12.0MApr 2024
$12.0MFeb 2020
$40.5MMar 2021
$41.5MNov 2018
Latest News
growth-positive
/PRNewswire/ -- SpliSense, a clinical-stage biotechnology company developing transformative RNA-based therapies for pulmonary diseases, today announced...
SpliSense, a clinical-stage biotechnology company, announced positive results from its Phase 2 study of SPL84, an antisense oligonucleotide therapy for cystic fibrosis (CF). The study showed improvements in lung function in up to 70% of participants, with no safety concerns identified. This marks the first evidence of potential clinical benefit of antisense oligonucleotide therapy in a pulmonary disease. The results validate SpliSenses platform, supporting the advancement of additional pulmonary programs into the clinic by early 2026. SPL84 has been granted Orphan Drug and Fast Track designations by the FDA, highlighting its potential to address unmet medical needs in CF treatment.
Product StageFDA approved/pending approval
growth-positive
SpliSense Receives FDA Fast Track Designation for SPL84 for the Treatment of Cystic Fibrosis
SpliSense, a biotechnology company specializing in RNA-based therapies for pulmonary diseases, announced that its lead product, SPL84, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). SPL84 is designed to treat cystic fibrosis (CF) patients with a specific genetic mutation. This designation will expedite the development and review process, potentially speeding up the delivery of this treatment to patients. The Fast Track status acknowledges the urgent need for effective treatments for CF, particularly for those with the 3849+10 Kb C->T mutation. SpliSenses approach involves using antisense oligonucleotides (ASOs) to correct mutations in the CFTR gene, aiming to restore normal protein function. SPL84 is currently in a global Phase 2 study.
Growth-Positive
SpliSense Announces FDA and EMA Grant Orphan Drug Designation to SPL84-23-1 for the Treatment of Cystic Fibrosis
Biopharmaceutical company SpliSense has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for SPL84-23-1, a therapy for cystic fibrosis (CF) and other pulmonary diseases. The ODD status, granted to drugs intended to treat rare diseases, provides companies with development incentives including tax credits for clinical trials, exemptions from FDA application fees, and potential marketing exclusivity for seven years following regulatory approval. SpliSense plans to commence clinical trials for SPL84-23-1 in mid-2022 in the US, Europe, and Israel.
CustomersPartners
growth-positive
Israeli firm SpliSense moves to clinical trials for cystic fibrosis treatment
SpliSense, an Israeli biopharmaceutical company, announced that its cystic fibrosis treatment technology has received orphan drug designation from both the US FDA and the European Medicines Agency. This designation is a significant milestone for the company, as it aims to address the unmet needs of cystic fibrosis patients. The treatment, SPL84-23, is an antisense oligonucleotide designed to correct a specific mutation in the CFTR gene. The Cystic Fibrosis Foundation invested $8.4 million in SpliSenses technology, part of a $28.5 million funding round. The company plans to initiate clinical studies in the US, Europe, and Israel later this year.
Investment
growth-positive
Inhaled drug could treat rare cystic fibrosis mutations
Jerusalem-based biotech company SpliSense is developing a new treatment for cystic fibrosis using mRNA technology. The companys technology manipulates defective messenger RNA to generate a fully functioning protein, offering hope for the 20% of CF patients with different genetic mutations. SpliSense has raised $28.5 million in a Series B round to fund clinical trials and the development of treatments for other pulmonary ailments. The treatment, based on Anti Sense Oligonucleotide (ASO), is meant to be inhaled and administered weekly for 10 minutes. SpliSense aims to address orphan conditions and potentially benefit the other 80% of CF patients. The first human clinical trials are planned for 2022.
Customers
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $41.5M |
| Last funding | $12M |
| Stage | B |
| Rounds | 4 |
| Investors | 6 |
Team Members
3
Employees: 11-50
Web & Social Links
| Website | splisense.com/ |
| Careers | Careers page |
Locations
Kalman Ya'akov Man St, Jerusalem, Israel
Photos & Videos
No files yet
SpliSense Business
Business models
B2B
Product stage
Clinical Trial
Employees
11-50
Sector
Health Tech & Life SciencesPharma & Medical BiotechnologyDrugs Discovery & DevelopmentTarget Customer
Healthcare & Life SciencesLife SciencesPharmaceuticalsBiotechnologyCore Technology
BiologicalsGenesTags (7)
medical-technologiespharma-companiespharmaceuticalsbiotechnologydrug-developmenttreatmentsgeneticsGeographic Markets
GlobalSpliSense Financials
$41.5M
Total funding
Undisclosed
Capital raised
$12M
Last funding
B
Funding stage
4
Total rounds
6
Investors
Cumulative Funding Raised Over Time ($)
$12.0MApr 2024
$12.0MFeb 2020
$40.5MMar 2021
$41.5MNov 2018
Private Equity Funding
Undisclosed Round
Apr 2024
$12M
Cystic Fibrosis Foundation (Lead)
,
Integra Holdings, OrbiMed
B Round
Mar 2021
$28.5M
OrbiMed, Cystic Fibrosis Foundation, Biotel, Integra Holdings, Israel Biotech Fund
Seed
Feb 2020
Undisclosed
Israel Biotech Fund
A Round
Nov 2018
$1M
Integra Holdings
SpliSense Lifecycle
Cumulative Funding Raised Over Time
$12.0MApr 2024
$12.0MFeb 2020
$40.5MMar 2021
$41.5MNov 2018
All Events
Undisclosed Round
Apr 2024
$12M
Cystic Fibrosis Foundation (Lead)
,
Integra Holdings, OrbiMed
B Round
Mar 2021
$28.5M
OrbiMed, Cystic Fibrosis Foundation, Biotel, Integra Holdings, Israel Biotech Fund
Seed
Feb 2020
Undisclosed
Israel Biotech Fund
A Round
Nov 2018
$1M
Integra Holdings
SpliSense News
6 articles
growth-positive
/PRNewswire/ -- SpliSense, a clinical-stage biotechnology company developing transformative RNA-based therapies for pulmonary diseases, today announced...
SpliSense, a clinical-stage biotechnology company, announced positive results from its Phase 2 study of SPL84, an antisense oligonucleotide therapy for cystic fibrosis (CF). The study showed improvements in lung function in up to 70% of participants, with no safety concerns identified. This marks the first evidence of potential clinical benefit of antisense oligonucleotide therapy in a pulmonary disease. The results validate SpliSenses platform, supporting the advancement of additional pulmonary programs into the clinic by early 2026. SPL84 has been granted Orphan Drug and Fast Track designations by the FDA, highlighting its potential to address unmet medical needs in CF treatment.
Product StageFDA approved/pending approval
growth-positive
SpliSense Receives FDA Fast Track Designation for SPL84 for the Treatment of Cystic Fibrosis
SpliSense, a biotechnology company specializing in RNA-based therapies for pulmonary diseases, announced that its lead product, SPL84, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA). SPL84 is designed to treat cystic fibrosis (CF) patients with a specific genetic mutation. This designation will expedite the development and review process, potentially speeding up the delivery of this treatment to patients. The Fast Track status acknowledges the urgent need for effective treatments for CF, particularly for those with the 3849+10 Kb C->T mutation. SpliSenses approach involves using antisense oligonucleotides (ASOs) to correct mutations in the CFTR gene, aiming to restore normal protein function. SPL84 is currently in a global Phase 2 study.
Growth-Positive
SpliSense Announces FDA and EMA Grant Orphan Drug Designation to SPL84-23-1 for the Treatment of Cystic Fibrosis
Biopharmaceutical company SpliSense has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for SPL84-23-1, a therapy for cystic fibrosis (CF) and other pulmonary diseases. The ODD status, granted to drugs intended to treat rare diseases, provides companies with development incentives including tax credits for clinical trials, exemptions from FDA application fees, and potential marketing exclusivity for seven years following regulatory approval. SpliSense plans to commence clinical trials for SPL84-23-1 in mid-2022 in the US, Europe, and Israel.
CustomersPartners
growth-positive
Israeli firm SpliSense moves to clinical trials for cystic fibrosis treatment
SpliSense, an Israeli biopharmaceutical company, announced that its cystic fibrosis treatment technology has received orphan drug designation from both the US FDA and the European Medicines Agency. This designation is a significant milestone for the company, as it aims to address the unmet needs of cystic fibrosis patients. The treatment, SPL84-23, is an antisense oligonucleotide designed to correct a specific mutation in the CFTR gene. The Cystic Fibrosis Foundation invested $8.4 million in SpliSenses technology, part of a $28.5 million funding round. The company plans to initiate clinical studies in the US, Europe, and Israel later this year.
Investment
growth-positive
Inhaled drug could treat rare cystic fibrosis mutations
Jerusalem-based biotech company SpliSense is developing a new treatment for cystic fibrosis using mRNA technology. The companys technology manipulates defective messenger RNA to generate a fully functioning protein, offering hope for the 20% of CF patients with different genetic mutations. SpliSense has raised $28.5 million in a Series B round to fund clinical trials and the development of treatments for other pulmonary ailments. The treatment, based on Anti Sense Oligonucleotide (ASO), is meant to be inhaled and administered weekly for 10 minutes. SpliSense aims to address orphan conditions and potentially benefit the other 80% of CF patients. The first human clinical trials are planned for 2022.
Customers
growth-positive
SpliSense Raises $28.5M to Advance Treatments for Rare CF Mutations
SpliSense has raised $28.5 million in funding to advance its antisense oligonucleotide (ASO) platform for the treatment of cystic fibrosis (CF) caused by certain rare mutations, and of other genetic lung diseases. The funding will enable the exploration of synthetic ASOs as a potential treatment for CF, offering hope of restoring adequate lung function to CF patients. SpliSense plans to launch a Phase 1/2 clinical trial of its lead ASO, SPL84-23, in 2022. Other earlier-stage CF therapies being developed by the company include SPL23-2 and SPL24-N. The funding round featured investors such as Orbimed, Israel Biotech Fund, Biotel Limited, Integra Holdings, and the Cystic Fibrosis Foundation.
Investment
SpliSense Team
Employee Info
| Employees (range) | 11-50 |
| Exact count | 17 |
| Team members | 3 |
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SpliSense Internal
Recent Updates
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Admin Info
| Confidence | 89/100 |
| Missing | video or image, markets, not claimed |
| BI Verification | Jenny Sotnik-Talisman |
| Registrar ID | 515535730 |
| Crunchbase | splisense |
| Creator | Jenny Sotnik-Talisman |
| Creator email | genys30@yahoo.com |
| Last updater | Yanina Wainscheinker |
| Updater email | yanina.wainscheinker@sncentral.org |
| Last update | 2024-10-28T00:00:00.000Z |
| Created | 2017-09-25T00:00:00.000Z |