Choroidal neovascularization

Akari Therapeutics and Peak Bio Announce Definitive Agreement to Merge as Equals Creating an Expanded Pipeline That Features a Novel Antibody Drug Conjugate (ADC) Toolkit

Retrieved on: 
Tuesday, March 5, 2024

Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.

Key Points: 
  • Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.
  • An assessment of the pipeline is planned, including program prioritization, updated timelines, near-term value creation opportunities, and other considerations.
  • Key highlights of the merger include:
    The merged pipeline features a robust ADC toolkit with novel payload and linker technologies.
  • Goodwin Procter LLP is serving as legal advisor to Akari and DLA Piper LLP is serving as legal advisor to Peak Bio.

Akari Therapeutics and Peak Bio Announce Definitive Agreement to Merge as Equals Creating an Expanded Pipeline That Features a Novel Antibody Drug Conjugate (ADC) Toolkit

Retrieved on: 
Tuesday, March 5, 2024

Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.

Key Points: 
  • Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages.
  • An assessment of the pipeline is planned, including program prioritization, updated timelines, near-term value creation opportunities, and other considerations.
  • Key highlights of the merger include:
    The merged pipeline features a robust ADC toolkit with novel payload and linker technologies.
  • Goodwin Procter LLP is serving as legal advisor to Akari and DLA Piper LLP is serving as legal advisor to Peak Bio.

PulseSight Therapeutics Launches to Advance Non-viral Gene Therapies with Disruptive Minimally-Invasive Delivery Technology for Severe Retinal Diseases

Retrieved on: 
Wednesday, February 28, 2024

Unique proprietary non-viral gene therapy platform with minimally invasive delivery technology providing long lasting gene expression and favorable distribution in the retina.

Key Points: 
  • Unique proprietary non-viral gene therapy platform with minimally invasive delivery technology providing long lasting gene expression and favorable distribution in the retina.
  • A substantially de-risked platform and two first-in-class gene therapies heading to the clinic, having the potential to become future blockbusters.
  • PARIS, Feb. 28, 2024 (GLOBE NEWSWIRE) -- PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral gene therapies with minimally-invasive delivery technology, launches today with seed finance from Pureos Bioventures and ND Capital.
  • PulseSight is currently raising a Series A financing round to advance its programs into clinical proof-of-concept.

Akari Therapeutics Presents Poster on Progress in Pre-Clinical Development of Long-Acting PAS-Nomacopan as a Potential Treatment for Geographic Atrophy at the 4th Annual Dry AMD Therapeutic Development Conference

Retrieved on: 
Thursday, November 16, 2023

BOSTON and LONDON, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the presentation of progress in the development of long-acting PASylated®-nomacopan as a potential treatment for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD) in a poster at the 4th Annual Dry AMD Therapeutic Development conference.

Key Points: 
  • BOSTON and LONDON, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the presentation of progress in the development of long-acting PASylated®-nomacopan as a potential treatment for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD) in a poster at the 4th Annual Dry AMD Therapeutic Development conference.
  • The poster was presented by Akari Chief Scientific Officer Miles Nunn on November 15, 2023.
  • The poster can be viewed on the Akari website at akaritx.com.
  • “Part of this progress is the advancement of a high yield manufacturing process that supports our program moving into clinical trials in 2024.”
    Long-acting PAS-nomacopan is a bispecific inhibitor of complement C5 and leukotriene B4 (LTB4).

RIBOMIC Phase I and II Data Published in the Eye: Full TOFU/RAMEN/TEMPURA Trial Results Demonstrate Clinical Proof of Concept of Umedaptanib Pegol in Exudative Age-Related Macular Degeneration (nAMD)

Retrieved on: 
Tuesday, December 5, 2023

TEMPURA is an investigator-sponsored, single-center, open-label, 4-month study of umedaptanib pegol in five treatment-naïve nAMD patients.

Key Points: 
  • TEMPURA is an investigator-sponsored, single-center, open-label, 4-month study of umedaptanib pegol in five treatment-naïve nAMD patients.
  • Throughout these studies umedaptanib pegol was safe, well tolerated, and effective to treat nAMD patients with no or short history of anti-VEGF treatment.
  • In nAMD patients with a long history of anti-VEGF treatment, umedaptanib pegol showed no additional benefit of monotherapy or the combination over Eylea®.
  • Notably, visual acuity decreased slightly in patients who switched from anti-VEGF (Eylea®) to umedaptanib pegol in the RAMEN study.

Akari Therapeutics to Present a Poster on Pre-Clinical Development of Long-Acting PAS-Nomacopan as a Potential Treatment for Geographic Atrophy at the 4th Annual Dry AMD Therapeutic Development Conference

Retrieved on: 
Monday, November 6, 2023

BOSTON and LONDON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that Chief Scientific Officer Miles Nunn will present a poster titled Development of PASylated®-Nomacopan for Treatment of Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (dAMD) at the 4th Annual Dry AMD Therapeutic Development conference taking place November 14-16 in Boston, MA.

Key Points: 
  • BOSTON and LONDON, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that Chief Scientific Officer Miles Nunn will present a poster titled Development of PASylated®-Nomacopan for Treatment of Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (dAMD) at the 4th Annual Dry AMD Therapeutic Development conference taking place November 14-16 in Boston, MA.
  • The poster will be presented on November 15, 2023 at 3:00 pm ET.
  • Long-acting PAS-nomacopan is a bispecific inhibitor of complement C5 and leukotriene B4 (LTB4).
  • It is in the final stages of pre-clinical development as a potential treatment for GA with the goals of providing a longer dose interval between intravitreal injections and reduction of choroidal neovascularization (CNV) risk associated with approved complement-only inhibitors currently used in GA treatment.

Aviceda Announces AVD-104, a Novel Glycomimetic Nanoparticle, Demonstrates Continued Clinical Safety in the Treatment of Geographic Atrophy Secondary to Macular Degeneration

Retrieved on: 
Wednesday, October 11, 2023

The Phase 2/3 SIGLEC trial is currently underway evaluating patients with geographic atrophy secondary to age-related macular degeneration (AMD).

Key Points: 
  • The Phase 2/3 SIGLEC trial is currently underway evaluating patients with geographic atrophy secondary to age-related macular degeneration (AMD).
  • Notably, no drug-related ocular inflammation, retinal vasculitis, choroidal neovascularization, infection, or optic nerve abnormalities were observed in any eyes.
  • Treatment also reduced choroidal neovascular (CNV) lesion sizes comparable to aflibercept in a laser induced CNV mouse model.
  • “We are eager for the continuation of parts 1 and 2 of the US Phase 2/3 SIGLEC clinical trial for patients with AMD-related geographic atrophy.

Aviceda To Present at Major European Healthcare Conferences Highlighting AVD-104, a Novel Glyco-Mimetic Nanoparticle for the Treatment of Geographic Atrophy from Macular Degeneration

Retrieved on: 
Monday, September 25, 2023

19:00-19:30, Mohamed Genead, MD, Panel 8 - Novel Therapeutics for Geographic Atrophy: How do we measure success for physicians, patients, and payers?

Key Points: 
  • 19:00-19:30, Mohamed Genead, MD, Panel 8 - Novel Therapeutics for Geographic Atrophy: How do we measure success for physicians, patients, and payers?
  • The study evaluated patients with GA secondary to AMD from Cohorts 1 and 2 in the Phase 2/3 (Part 1) SIGLEC trial.
  • Notably no drug related inflammation, retinal vasculitis, choroidal neovascularization, infection, or optic nerve abnormalities were seen in any eyes.
  • Though the SIGLEC trial recently began in June of this year, Aviceda has already completed the dose-escalation enrollment for all cohorts in Part 1.

Annexon Presents ARCHER Trial Results at ASRS 2023 Highlighting Potential of ANX007 as a Differentiated Treatment for Geographic Atrophy

Retrieved on: 
Sunday, July 30, 2023

BRISBANE, Calif., July 30, 2023 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement-based medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today presented results from the ongoing ARCHER trial in patients with geographic atrophy (GA), underscoring ANX007’s potentially distinct neuroprotective mechanism of action and demonstration of consistent protection from vision loss. Data were presented during an oral presentation titled, “Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Intravitreal ANX007: Results of the ARCHER Study,” at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.

Key Points: 
  • Data were presented during an oral presentation titled, “Treatment of Geographic Atrophy Secondary to Age-Related Macular Degeneration with Intravitreal ANX007: Results of the ARCHER Study,” at the American Society of Retina Specialists (ASRS) 2023 Annual Meeting taking place July 28 – August 1, 2023 in Seattle.
  • “The results from ARCHER demonstrated dose and time dependent protection of visual function in GA across multiple measures.
  • Annexon conducted additional analyses to further evaluate the effect of ANX007 treatment on BCVA and GA lesion area.
  • The six-month off-treatment follow-up period of the ARCHER trial is ongoing, and Annexon plans to report final results following study conclusion.

Annexon Topline Data from ARCHER Phase 2 Trial of ANX007 in Geographic Atrophy Demonstrated Statistically Significant, Dose-Dependent Preservation of Visual Function

Retrieved on: 
Wednesday, May 24, 2023

Patients in the pooled treatment group showed a 59% reduction in risk of >15-letter loss (n=181, p=0.008).

Key Points: 
  • Patients in the pooled treatment group showed a 59% reduction in risk of >15-letter loss (n=181, p=0.008).
  • The primary endpoint of mean rate of change (slope) in GA lesion area compared to sham at 12 months did not reach statistical significance.
  • The totality of the data on ANX007 from the ARCHER trial are promising, with the demonstrated preservation of functional vision in GA patients, regardless of their lesion location or size.
  • Preclinical models have demonstrated that inhibition of C1q protects photoreceptor cell synapses, and importantly, photoreceptor cell function.