ISEE - UPCOMING CATALYST MAKES IVERIC BIO A MUST WATCH!
UPCOMING CATALYST MAKES IVERIC BIO A MUST WATCH!
06 JUL UPCOMING CATALYST MAKES IVERIC BIO A MUST WATCH!
Posted at 10:37h in Biotechnology by admin 0 Comments 1 Like Share
Iveric Bio, Inc. ( NASDAQ: ISEE) is a clinical-stage biopharmaceutical company developing transformative therapies for retinal diseases with significant unmet needs. The Company is developing a diverse portfolio of therapeutic candidates at various stages of development. The Company’s lead product candidate is Zimura (avacincaptad pegol), a C5 inhibitor that targets and inhibits the two triggers of cell death, in addition to preserving the remainder of the pathway. The candidate bypasses C3 and promotes phagocytosis of antigens and apoptotic cells by maintaining Opsonization and perfusion. Through inhibition of C5, Zimura has the potential to prevent cellular apoptosis.
Iveric Bio, Inc. (NASDAQ: ISEE)
Market Cap: $1.18B; Current Share Price: 10.15 USD
Data by YCharts
We take a holistic look at the Company through a SWOT analysis below:
Strength
Zimura is currently being evaluated in a second phase 3 trial and has completed patient enrollment. The topline results from the trial are expected to be announced in Q3,2022. The first phase 3 GATHER1 trial reported positive results with a 27% statistically significant reduction in GA growth over 12 months, which was its primary endpoint. Moreover, the FDA has granted a Special Protocol Assessment (SPA) for the GATHER2 trial.
The Company plans to file for an NDA/MAA approval based on the positive results from the 12-month GATHER2 data. Iveric is gearing up for the commercial launch of Zimeric and intends to initiate clinical development in intermediate AMD in the fourth quarter of 2022.
Iveric is developing an extensive pipeline of candidates, including an HtrA1 inhibitor intended to treat GA, which is currently under preclinical development. The Company plans to file an IND in mid-2023. Zimmer is also being evaluated in a Phase 2 trial for the treatment of Autosomal Recessive Stargardt Disease (STGD1) in an ongoing problem with expanded enrollment.
The Company is also developing a pipeline of AAV-Gene therapy candidates currently under preclinical development for the treatment of indications such as Rhodopsin-mediated autosomal dominant RP, Leber congenital amaurosis type 10, autosomal recessive Stargardt disease, and Usher syndrome type 2A.
Weakness
The Company faces stiff competition from Apellis (NASDAQ: APLS), which has recently submitted a New Drug Application (NDA) to the FDA for intravitreal pegcetacoplan, an investigational, targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The NDA submission is based on results from the Phase 3 DERBY and OAKS studies and a Phase 2 FILLY study at 12 months. The FDA’s decision is expected in 2022.
Apellis seems ahead of the Company at this stage. However, its clinical results had mixed results, with positive results from a Phase 3 trial but missing endpoints in another trial at 12 months. The Company pooled the data from the trials, which resulted in statistically significant improvements, but it is yet to be seen if the Company’s approach works.
However, the main differentiating factor between the two companies is that while Iveric’s trials are confined to non-foveal patients, denoting an earlier stage of the disease, Apellis has enrolled foveal patients too.
Opportunity
Macular Degeneration is caused by the age-related deterioration of the retina’s central portion, named Macula. The macula is responsible for focusing the eye’s central vision and regulating reading, driving, and facial and color recognition abilities. It collates the images from the center of the field of vision and sends them to the optic nerves so they can be relayed to the brain. Macular degeneration is characterized by wavy or blurred vision and eventually loss of central vision, though peripheral vision may work fine.
The Disease is categorized as “Dry” or “Wet,” with an estimated 85% of the cases being “dry” or atrophic and over 15% of the patients being “WET.” It progresses in three stages, namely early-AMD, characterized by yellow deposits named Drusen accumulated underneath the retina. The Intermediate stage sees some changes in vision and pigment in the retina, followed by the final Late AMD stage, where vision loss is noticeable.
Though the exact cause of this illness is still unknown, certain hereditary and environmental factors have been found to play a crucial role. Age is among the most critical factors, with people over 55 at a greater risk of contracting the disease. In addition, genetics, a family history of AMD, and smoking are other factors that can cause this disease.
Geographic Atrophy (GA) is the progressive degeneration of the macula characterized by the localized atrophy of the outer retinal tissue, retinal pigment epithelium, and choriocapillaris. It typically originates in the perifoveal region and spreads to the fovea, leading to central scotomas and causing loss of visual acuity. The symptoms of GA are usually attributed to aging, which delays the diagnosis and leads to a more severe vision loss. Furthermore, according to an estimate, over 8 million people are affected by GA worldwide.
AMD is the leading cause of vision loss for people over 60 years in the U.S, affecting an estimated 11 million people in the United States, and is likely to reach epidemic proportions by 2050, affecting over 22 million Americans in the absence of research and treatment breakthroughs. According to an estimate, the direct cost of vision loss in North America is around $512.8 billion, and the indirect costs are $179 billion.
According to a report by Transparency Market Research, the global macular degeneration treatment market was worth over US$ 6.1 billion in 2017 and is likely to grow at a CAGR of 6.4% to reach US$ 11.1 billion by 2026. The increase in the aging population and rise in awareness levels will propel the growth in the market.
There is no cure for AMD yet; however, some research breakthroughs provide hope for the patients. Current treatment options start with nutritional therapy focused on an antioxidant-rich diet. Laser photocoagulation was the earliest treatment for leaking blood vessels in wet AMD; this was followed by Photodynamic Therapy (PDT) with Visudyne™, wherein a Visudyne™ is injected intravenously into the patient’s arm, which is then activated through shining non-thermal laser light into the eyes. This treatment was a considerable improvement over conventional therapeutic options as it used a low-level, non-thermal laser to seal off leaking blood vessels while leaving the healthy ones intact.
However, these cannot prevent the reoccurrence of the illness leading to multiple treatment sessions. Most importantly, they can only halt the disease’s degeneration or rate of progression and cannot restore lost vision. Additionally, only 10-15% of CNV lesions are eligible for laser treatment. They also have side effects such as scarring or additional vision loss because of the use of lasers.
Hence, a significant breakthrough is needed to prevent repeated reoccurrence of the condition after treatment and offer relief from all forms of wet AMD.
Threat
The Company is focused on developing a pipeline that expands Zimura’s indications and building a franchise that treats all stages of AMD. Besides a single candidate being evaluated in diverse manifestations, the Company is also developing a pipeline of AAV-Gene therapy candidates. The other symptoms that the candidate is being assessed are undergoing preclinical development.
Clinical Trials are fraught with risk and uncertainty. There is a possibility that the candidates in the Company’s developmental pipeline may not be able to meet their clinical endpoints in trials. The Company may fail to receive regulatory approval for any other candidates, resulting in a setback for the other candidates in the pipeline.
However, a diverse pipeline will help mitigate the risk in case of adverse results or the failure to meet endpoints in any of its ongoing trials. The success of its clinical trials will allow the Company to advance its pipeline, but it should also be prepared to face any setbacks in case its ongoing attempts fail to meet its endpoints.
Key Takeaways
· Iveric aims to build a franchise that offers comprehensive therapeutic solutions to treat all stages of AMD with Zimura and IC-500. The results from the GATHER 1 trial demonstrate early and continuously increasing treatment effects observed over 18 months. In addition, post-hoc analyses suggest that the candidate can also change the natural course of the disease by being able to affect the condition in the earlier stages, such as drusen, iRORA, and cRORA. Furthermore, the lifecycle management strategy for the candidate involves the development of additional indications, sustained delivery, and exploring other mechanisms of action such as HtrA1.
· Upcoming milestones of the Company include the topline data readout from the GATHER 2 trial in Q3, 2022, the initiation of a clinical trial evaluating Zimura in intermediate AMD in Q4,2022 and the submission of an IND for IC-500 IND in mid-2023.
· The Company is helmed by an experienced management team with extensive experience in ophthalmology. Glenn Sblendorio, the Chief Executive Officer, has served as the President, Chief Financial Officer, and member of the board of directors of The Medicines Company from 2006 to 2016. Before this stint, he served as the Executive Vice President and Chief Financial Officer of Eyetech Pharmaceuticals, Inc. from 2002 through 2005. The president of the Company, Pravin U. Dugel, MD, was earlier the Managing Partner, Retinal Consultants of Arizona and the Retinal Research Institute; Clinical Professor, USC Eye Institute, Keck School of Medicine, University of Southern California; and Founding Member, Spectra Eye Institute in Sun City, Arizona.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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References
https://investors.ivericbio.com/static-files/daea4318-04e2-47bf-b85e-1ab3ad1586a6
https://www.evaluate.com/vantage/articles/events/company-events/biotechs-important-data-reveals