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Details:
RGN-259 (Thymosin beta 4) is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2023
Details:
RGN-259 (Thymosin beta 4) is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
RGN-259 represents a new approach to corneal healing, as there is currently no pharmaceutical agent that has shown corneal repair and anti-inflammatory properties.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2021
Details:
RegeneRx drug candidate, RGN-259, is the subject of two Phase 3 clinical trials in the U.S. for patients with dry eye syndrome and neurotrophic keratopathy (an orphan indication). We expect the results of these trials to be available in 2020.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Roth Capital Partners
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement July 01, 2021
Details:
Completed analysis demonstrated a number of favorable efficacy parameters in ARISE-3 and, most importantly, numerous significant sign and symptom improvements with RGN-259 when pooling the patient data from all three phase 3 clinical trials.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2021
Details:
The objective of this ARISE-3 Trial is to compare the safety and efficacy of RGN-259 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2021
Details:
The statistically significant improvement was seen at one and two weeks after treatment, and post-exposure in a controlled adverse environment after two weeks of treatment with RGN-259 compared to placebo (p=0.0104, 0.0307, and 0.0046, respectively).
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2021
Details:
RGN-259 continued to demonstrate safety in treatment of dry eye syndrome consistent with previous clinical trials. In the ARISE-3 trial, there were no serious adverse events with only mild to moderate adverse events in both the active and placebo arms.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2021
Details:
ARISE-3 Phase 3 clinical trial database evaluating RGN-259 eyedrops for the treatment of dry eye syndrome has been locked after collecting and verifying patient data from 20 U.S. clinical sites participating in the study.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2021
Details:
RGN-259, the Company's ophthalmic eye drop, recently complete a phase 3 clinical trial for dry eye syndrome in the U.S. and is expected to report top line results for the ARISE-3 clinical trial in early 2021.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Details:
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 28, 2020
Details:
ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015 and has completed two phase 3 studies in the U.S. for dry eye: ARISE-1 and ARISE-2.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2020
Details:
A multi-institutional team of scientists from eight American research centers published a research paper on new therapeutic approaches for COVID-19 in which they propose that Thymosin beta 4 (Tβ4), because of its ability to induce fibrinolysis.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Infections and Infectious Diseases Product Name: RGN-352
Highest Development Status: PreclinicalProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 08, 2020
Details:
ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after two weeks of administration in 700 subjects with dry eye syndrome.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2020
Details:
Six out of 10 patients in the RGN-259 treated group and 1 out of 8 patients in the placebo treated group achieved complete corneal healing in 4 weeks.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
The results of this study suggest that Tβ4-mediated HCEC proliferation and migration are associated with increased ATP levels, P2X7 R-mediated Ca2+ influx, and the ERK1/2 signaling pathway.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 02, 2020
Details:
RegeneRx in-licensed the intellectual property relating to the use of T?4 from the Henry Ford Hospital System in Detroit, MI based on work performed by Dr. Michael Chopp and his colleagues.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 13, 2020
Details:
ARISE-3 will enroll over 700 eye dry patients at 19 eye clinics across the U.S. for two weeks of treatment, comparing the safety and efficacy of RGN-259 against placebo.
Lead Product(s): Thymosin Beta-4
Therapeutic Area: Ophthalmology Product Name: RGN-259
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2020
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