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Biosplice Therapeutics

biosplice.com

Founded Year

2008

Stage

Series B | Alive

Total Raised

$561.5M

Last Raised

$120M | 2 yrs ago

About Biosplice Therapeutics

Biosplice Therapeutics is a clinical-stage biotechnology company pioneering therapeutics based on alternative pre-mRNA splicing for major diseases. Its scientific platform is based on biological discoveries that govern tissue specialization and enable it to selectively eliminate harmful proteins using small molecules. From the company's foundational discoveries in Wnt pathway modulation to unlocking the broad therapeutic potential of the CLK/DYRK target class, its focus is on the realization of new, potentially curative therapies for patients by selectively reprogramming cellular behavior.

Headquarters Location

9360 Towne Centre Drive Suite 160

San Diego, California, 92121,

United States

858-926-2900

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Research containing Biosplice Therapeutics

Get data-driven expert analysis from the CB Insights Intelligence Unit.

CB Insights Intelligence Analysts have mentioned Biosplice Therapeutics in 2 CB Insights research briefs, most recently on Oct 13, 2022.

Expert Collections containing Biosplice Therapeutics

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Biosplice Therapeutics is included in 4 Expert Collections, including Unicorns- Billion Dollar Startups.

U

Unicorns- Billion Dollar Startups

1,201 items

C

Cancer

4,784 items

Pharmaceutical and biotechnology companies with cancer therapy drug candidates.

R

Regenerative Medicine

1,818 items

Regenerative medicine refers to the process of activating, replacing, engineering or regenerating human genetic material, cells, tissues or organs to restore normal function. It also includes bioengineered tissues used for in vitro testing (e.g. organ-on-a-chip, organoids).

B

Biopharma Tech

15,535 items

Companies involved in the research, development, and commercialization of chemically- or biologically-derived therapeutic & theranostic drugs. Excludes vitamins/supplements, CROs/clinical trial services.

Biosplice Therapeutics Patents

Biosplice Therapeutics has filed 1 patent.

The 3 most popular patent topics include:

  • Transcription factors
  • G protein coupled receptors
  • Clusters of differentiation
patents chart

Application Date

Grant Date

Title

Related Topics

Status

7/27/2020

9/20/2022

Food additives, Excipients, Fluoroarenes, Amines, Metal halides

Grant

Application Date

7/27/2020

Grant Date

9/20/2022

Title

Related Topics

Food additives, Excipients, Fluoroarenes, Amines, Metal halides

Status

Grant

Latest Biosplice Therapeutics News

Biosplice Announces Data from Recent Clinical Trials in Knee Osteoarthritis and the Initiation of a New Phase 3 Trial

Nov 11, 2022

San Diego, California, UNITED STATES SAN DIEGO, Nov. 11, 2022 (GLOBE NEWSWIRE) -- Biosplice Therapeutics, Inc. (“Biosplice”), a clinical-stage biotechnology company pioneering first-in-class therapeutics based on small-molecule inhibition of CLK/DYRK kinases, announced today highlights from three Phase 3 clinical trials, OA-07, OA-10 and OA-11 for its knee OA drug candidate, lorecivivint. Recent Biosplice data, particularly in the OA-07 long-term efficacy trial, demonstrate both symptomatic and structural benefit in treating knee osteoarthritis in patients with early joint damage, defined as KL2 and early-stage KL3 patients, which represent an estimated 70% of the knee OA population. Upon the conclusion of OA-11, a 12-month study, completing participants were able to enroll in an additional Phase 3 trial, OA-07, which served as a long-term extension study with multiple injections. During the first year of the OA-07 study, patients and investigators remained blinded and patients received injections of LOR on an annual basis, allowing Biosplice to capture both long-term and repeat-injection safety and efficacy data. These data show clinically significant improvement in medial joint space width relative to placebo, with an effect size of 0.13 and 0.20 millimeters in overall KL2 and early-stage KL2 patients, respectively. Moreover, OA-07 data demonstrate a significant improvement in WOMAC Pain and robust trends in Pain NRS (daily pain score) as well as WOMAC function in all subjects. Strong observed efficacy in this OA-07 study, along with data from the OA-10 trial, helped form the basis of trial design for Biosplice’s next Phase 3 trial, OA-21, as described below. In two prior Phase 3 clinical trials, OA-10 and OA-11, lorecivivint, demonstrated clinical efficacy in earlier, less structurally damaged patients, although these trials fell short of reaching statistical significance in their primary endpoints of Pain NRS (daily pain score) at week 12 with all subjects. Extensive analysis has identified two potential confounding factors: participants in OA-10 and OA-11 had the most structurally advanced disease enrolled in the program to date and adequate separation from placebo was potentially suppressed by mobility-limiting COVID lockdown protocols, as the trials were conducted during the COVID pandemic. Confounding effects of the pandemic on activity levels and pain PROs in knee OA patients have been widely reported1. Consistent with observations of OA-07 data noted above, the six-month long OA-10 study demonstrated that lorecivivint outperformed placebo in the KL2 and early-stage KL3 patients (i.e., less structurally damaged patients), a key subgroup that represents the majority of the knee OA patient population. This subgroup showed consistent benefit with lorecivivint over placebo in multiple measurement time periods and metrics, such as pain NRS, WOMAC pain, WOMAC function and patient global assessment of disease activity in the OA-10 study. Consistent with the clinical program to date, lorecivivint continued to appear safe and well-tolerated in the recently completed studies, with no safety signals with repeat injections. “Healthcare professionals need an approach for treating knee osteoarthritis that can provide durable pain relief, improve functionality, and be safely utilized over a long period of time,” said Biosplice Chief Medical Officer, Yusuf Yazici, MD. “Biosplice aims to provide physicians a knee osteoarthritis treatment that does not compromise between efficacy and safety. Our local, intra-articular injection hopes to provide a safe, effective and much-needed structure-modifying treatment option to physicians and patients alike. Our data to date suggest that earlier, less structurally damaged patients provide the ideal target population to study in our next Phase 3 trial, which we expect will further support the beneficial effects of lorecivivint in this very important patient population.” Biosplice conducted a meeting with the FDA in Q3 2022, in which its next phase 3 study for lorecivivint was discussed. Designated OA-21, this next phase 3 trial is designed as a 16-week study with a primary endpoint of Pain NRS at 12 weeks and enrollment is expected to begin in Q4 2022. This study will further evaluate the impact of lorecivivint on knee osteoarthritis pain and function and has been modeled after the early, less structurally damaged patient population that has shown consistent responses across Biosplice’s Phase 2 and Phase 3 clinical trials. Biosplice will be presenting data in three poster presentations and one oral presentation at the 2022 ACR Annual Meeting as outlined below. Oral presentation details:

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Biosplice Therapeutics Frequently Asked Questions (FAQ)

  • When was Biosplice Therapeutics founded?

    Biosplice Therapeutics was founded in 2008.

  • Where is Biosplice Therapeutics's headquarters?

    Biosplice Therapeutics's headquarters is located at 9360 Towne Centre Drive, San Diego.

  • What is Biosplice Therapeutics's latest funding round?

    Biosplice Therapeutics's latest funding round is Series B.

  • How much did Biosplice Therapeutics raise?

    Biosplice Therapeutics raised a total of $561.5M.

  • Who are the investors of Biosplice Therapeutics?

    Investors of Biosplice Therapeutics include SymBiosis, Verition Fund Management, Sands Capital, Eventide Asset Management, aMoon Fund and 7 more.

  • Who are Biosplice Therapeutics's competitors?

    Competitors of Biosplice Therapeutics include Lubris BioPharma.

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Aldeyra Therapeutics

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