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- PPY988 / Novartis
HORIZON: A Phase 2 Study to Evaluate the Safety and Efficacy of Two Doses of GT005/PPY988 in Patients With Geographic Atrophy (DEMAND) - Sep 24, 2024 - Abstract #AAO2024AAO_2369;
Incidence of ocular serious adverse events was 2.3%, 5.8% and 0%, respectively. Conclusions Based on the interim results (Week 48), the benefit-risk profile of PPY988 was not favorable for further development in GA.
- ||| PPY988 / Novartis
Enrollment closed, Trial completion date, Trial primary completion date: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Dec 19, 2023
P2, N=255, Active, not recruiting, Sponsor: Gyroscope Therapeutics Limited
Conclusions Based on the interim results (Week 48), the benefit-risk profile of PPY988 was not favorable for further development in GA. Terminated --> Active, not recruiting | Trial completion date: Aug 2023 --> Jun 2024 | Trial primary completion date: Aug 2023 --> Jun 2024
- || PPY988 / Novartis
Phase classification, Trial completion date: ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study (clinicaltrials.gov) - Nov 7, 2023
P2, N=225, Enrolling by invitation, Sponsor: Gyroscope Therapeutics Limited
Terminated --> Active, not recruiting | Trial completion date: Aug 2023 --> Jun 2024 | Trial primary completion date: Aug 2023 --> Jun 2024 Phase classification: P=N/A --> P2 | Trial completion date: Sep 2028 --> Jun 2028
- | PPY988 / Novartis
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Sep 15, 2023
P2, N=98, Terminated, Sponsor: Gyroscope Therapeutics Limited
N=75 --> 98 | Trial completion date: Nov 2025 --> Aug 2023 | Recruiting --> Terminated | Trial primary completion date: Nov 2024 --> Aug 2023; Terminated for interim analysis demonstrating futility (trial highly unlikely to meet efficacy outcome). The trial is not ending early because of medical problems or concerns.
- |||||| PPY988 / Novartis
Trial completion date, Trial termination, Trial primary completion date: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Sep 14, 2023
P2, N=255, Terminated, Sponsor: Gyroscope Therapeutics Limited
The trial is not ending early because of medical problems or concerns. Trial completion date: Sep 2025 --> Aug 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Aug 2023
- ||||| PPY988 / Novartis
Trial completion date, Trial termination: FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD (clinicaltrials.gov) - Sep 14, 2023
P1/2, N=56, Terminated, Sponsor: Gyroscope Therapeutics Limited
Trial completion date: Jan 2027 --> Aug 2023 | Active, not recruiting --> Terminated; Terminated for interim analysis demonstrating futility (trial highly unlikely to meet efficacy outcome). The trial is not ending early because of medical problems or concerns.
- ||| PPY988 / Novartis
Enrollment closed: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Dec 16, 2022
P2, N=255, Active, not recruiting, Sponsor: Gyroscope Therapeutics Limited
The trial is not ending early because of medical problems or concerns. Recruiting --> Active, not recruiting
- || PPY988 / Novartis
Trial completion date, Trial primary completion date: EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Dec 5, 2022
P2, N=75, Recruiting, Sponsor: Gyroscope Therapeutics Limited
Recruiting --> Active, not recruiting Trial completion date: Feb 2024 --> Nov 2025 | Trial primary completion date: Feb 2023 --> Nov 2024
- || Review, Journal: Gene targeting as a therapeutic avenue in diseases mediated by the complement alternative pathway. (Pubmed Central) - Nov 15, 2022
This review explains key concepts of RNA and DNA targeting and discusses assets in clinical development for the treatment of diseases driven by the alternative pathway, including the RNA-targeting therapeutics ALN-CC5, ARO-C3, and IONIS-FB-LRX, and the gene therapies GT005 and HMR59. These therapies are but the spearhead of potential drug candidates that might revolutionize the field in coming years.
- ||||| PPY988 / Novartis
P1/2 data: Preliminary results of phase 1/2 GT005 gene therapy to induce factor I expression in geographic atrophy #AMD using subretinal delivery system presented by David Eichenbaum @RetinaSociety 2022. Associated complications discussed (Twitter) - Nov 4, 2022
- || PPY988 / Novartis
Enrollment closed, Trial completion date, Trial primary completion date: FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD (clinicaltrials.gov) - Oct 13, 2022
P1/2, N=56, Active, not recruiting, Sponsor: Gyroscope Therapeutics Limited
These therapies are but the spearhead of potential drug candidates that might revolutionize the field in coming years. Recruiting --> Active, not recruiting | Trial completion date: Oct 2026 --> Jan 2027 | Trial primary completion date: Oct 2022 --> May 2023
- |||||| PPY988 / Novartis
New trial: ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study (clinicaltrials.gov) - Aug 1, 2022
P=N/A, N=200, Enrolling by invitation, Sponsor: Gyroscope Therapeutics Limited
- GT005 / Gyroscope Therap
Preliminary Results from a Phase I/II Gene Therapy (FOCUS) of Subretinally Delivered GT005 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration () - Jul 18, 2022 - Abstract #ASRS2022ASRS_268;
- GT005 / Gyroscope Therap
Nonclinical Safety and Pharmacology of an Investigational Gene Therapy Targeting the Complement Pathway for the Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration (GT005) (Poster Board Number: M-166; Hall D) - May 6, 2022 - Abstract #ASGCT2022ASGCT_1561;
GT005 led to local hCFI expression and wide-spread secretion of hCFI protein. Ocular dose-dependent inflammation-induced changes were observed, and correlated strongly with anti-hCFI antibody generation.
- GT005 / Gyroscope Therap
GT005, an AAV Gene Therapy Targeting the Alternative Pathway of the Complement System for the Treatment of Geographic Atrophy (Poster Board Number: M-30; Hall D) - May 6, 2022 - Abstract #ASGCT2022ASGCT_1504;
Collectively, the non-clinical data provided here demonstrate the therapeutic potential of rAAV2-mediated expression of hCFI in slowing disease progression of GA by limiting complement-mediated inflammation in the posterior segment of the eye. More importantly, these data presented have paved the way for the evaluation of GT005 in Phase I and II clinical studies for GA secondary to AMD.
- GT005 / Gyroscope Therap
Preclinical pharmacology and safety of GT005, an investigational gene therapy targeting the complement pathway for the treatment of Geographic Atrophy (F0097) - Apr 29, 2022 - Abstract #ARVO2022ARVO_2545;
GT005 led to local hCFI expression. Ocular dose-dependent inflammation-induced changes were observed, and correlated strongly with anti-hCFI antibody generation.
- GT005 / Gyroscope Therap
In vivo expression and efficacy following subretinal delivery of GT005, an investigational gene therapy for the treatment of geographic atrophy (GA) ([Virtual]) - Apr 29, 2022 - Abstract #ARVO2022ARVO_2537;
GT005 shows therapeutic efficacy in the mouse CNV model, a model of wet AMD in which complement activation plays a key pathophysiological role. These data support the therapeutic potential of GT005 for the treatment of GA by complement system modulation.
- GT005 / Gyroscope Therap
Preliminary Results from a First-in-human Phase I/II Gene Therapy Study (FOCUS) of Subretinally Delivered GT005, an Investigational AAV2 Vector, in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (Four Seasons Blrm 1) - Apr 29, 2022 - Abstract #ARVO2022ARVO_850;
P1/2
These data support the therapeutic potential of GT005 for the treatment of GA by complement system modulation. GT005 had a positive safety profile at 2E10 to 2E11vg with no signs of GT005-related inflammation.
- || Review, Journal: Review of gene therapies for age-related macular degeneration. (Pubmed Central) - Apr 19, 2022
Retinal gene therapies offer the potential for life-changing treatment for chronic conditions like age-related macular degeneration with a single administration. In doing so, gene therapies change the landscape of treatment options for these chronic conditions for both patient and provider.
- ||| PPY988 / Novartis
Enrollment change, Trial completion date, Trial primary completion date: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Mar 24, 2022
P2, N=250, Recruiting, Sponsor: Gyroscope Therapeutics Limited
In doing so, gene therapies change the landscape of treatment options for these chronic conditions for both patient and provider. N=180 --> 250 | Trial completion date: Oct 2023 --> Oct 2025 | Trial primary completion date: Oct 2022 --> Oct 2024
- GT005 / Gyroscope Therap
[VIRTUAL] GT005, an investigational AAV2 vector encoding complement factor I, for geographic atrophy (Studio 3) - Sep 10, 2021 - Abstract #ESGCT2021ESGCT_68;
- ||| PPY988 / Novartis
Enrollment change, Trial completion date, Trial primary completion date: FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD (clinicaltrials.gov) - Jun 24, 2021
P1/2, N=65, Recruiting, Sponsor: Gyroscope Therapeutics Limited
N=180 --> 250 | Trial completion date: Oct 2023 --> Oct 2025 | Trial primary completion date: Oct 2022 --> Oct 2024 N=45 --> 65 | Trial completion date: Feb 2025 --> Oct 2026 | Trial primary completion date: Feb 2022 --> Oct 2022
- | PPY988 / Novartis
Trial completion date, Trial primary completion date: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Apr 22, 2021
P2, N=180, Recruiting, Sponsor: Gyroscope Therapeutics Limited
N=45 --> 65 | Trial completion date: Feb 2025 --> Oct 2026 | Trial primary completion date: Feb 2022 --> Oct 2022 Trial completion date: Feb 2022 --> Oct 2023 | Trial primary completion date: Feb 2022 --> Oct 2022
- | PPY988 / Novartis
Trial completion date: EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Feb 21, 2021
P2, N=75, Recruiting, Sponsor: Gyroscope Therapeutics
Trial completion date: Feb 2022 --> Oct 2023 | Trial primary completion date: Feb 2022 --> Oct 2022 Trial completion date: Feb 2023 --> Feb 2024
- ||| PPY988 / Novartis
Enrollment open: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Nov 12, 2020
P2, N=180, Recruiting, Sponsor: Gyroscope Therapeutics
Trial completion date: Feb 2023 --> Feb 2024 Not yet recruiting --> Recruiting
- | PPY988 / Novartis
Trial completion date, Trial primary completion date: FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD (clinicaltrials.gov) - Nov 4, 2020
P1/2, N=45, Recruiting, Sponsor: Gyroscope Therapeutics
Not yet recruiting --> Recruiting Trial completion date: Jun 2021 --> Feb 2025 | Trial primary completion date: Jun 2021 --> Feb 2022
- |||| PPY988 / Novartis
New P2 trial: HORIZON: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Sep 27, 2020
P2, N=180, Not yet recruiting, Sponsor: Gyroscope Therapeutics
- ||| PPY988 / Novartis
Enrollment open: EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Jul 14, 2020
P2, N=75, Recruiting, Sponsor: Gyroscope Therapeutics
Trial completion date: Jun 2021 --> Feb 2025 | Trial primary completion date: Jun 2021 --> Feb 2022 Not yet recruiting --> Recruiting
- |||| PPY988 / Novartis
New P2 trial: EXPLORE: A Phase II Study to Evaluate the Safety and Efficacy of Two Doses of GT005 (clinicaltrials.gov) - Jun 18, 2020
P2, N=75, Not yet recruiting, Sponsor: Gyroscope Therapeutics
- ||| PPY988 / Novartis
Enrollment change, Trial completion date, Trial primary completion date: FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD (clinicaltrials.gov) - Mar 10, 2020
P1/2, N=35, Recruiting, Sponsor: Gyroscope Therapeutics
Not yet recruiting --> Recruiting N=10 --> 35 | Trial completion date: Feb 2021 --> Jun 2021 | Trial primary completion date: Feb 2021 --> Jun 2021
- | PPY988 / Novartis
New P1/2 trial: FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD (clinicaltrials.gov) - Feb 19, 2019
P1/2, N=10, Recruiting, Sponsor: Gyroscope Therapeutics