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Major Upcoming Catalysts Make Aldeyra Therapeutics a worthy Contender for your Portfolio

25 Jan Major Upcoming Catalysts Make Aldeyra Therapeutics a worthy Contender for your Portfolio

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) is developing innovative approaches that help modulate the immune system to combat, ocular, fibrosis and Cytokine release syndrome. The Company recently released topline results from a Phase III trial of Reproxalap being developed for the treatment of dry eye syndrome. The results demonstrate that the candidate offers improvement over conventional therapeutics currently in use on multiple fronts such as ocular dryness, discomfort, and Schirmer’s test. The Company intends to initiate a phase 3 main cohort clinical trial named TRANQULITY in Dry Eye Disease and will begin enrollment of subjects in February 2021.

The Company is expecting to release the results from its Phase 3 trial INVIGORATE in Allergic Conjunctivitis in H1, 2021. Aldeyra has initiated the clinical testing of ADX-629 to establish a proof of concept in three types of severe inflammation namely Cytokine Release Syndrome, which is undergoing a phase 2 clinical trial in COVID-19, Phase2 allergen-challenge clinical trial in atopic asthma and a Phase 2 clinical trial in psoriasis and expects to assess the results in 2021.

Aldeyra is also engaged in a phase 3 trial to evaluate the safety and efficacy of ADX-2191 for the treatment of Proliferative vitreoretinopathy (PVR) and is exploring additional indications such as primary intraocular lymphoma.

Aldeyra Therapeutics, (NASDAQ: ALDX)

Market Cap: $561.19M; Current Share Price: 12.29 USDChart
Data by YCharts

Dry Eye Syndrome is characterized by the inability to produce sufficient amount or quality of tears which leads to lack of lubrication and nourishment to the surface of the eye and manifests as chronic eye irritation, inflammation and damage to the surface. There are over 16 million diagnosed cases of dry eye syndrome in the U.S alone.

Dry Eye leads to discomfort and pain and can greatly impact the quality of life by making it difficult to perform everyday functions such as reading, driving, using computers and performing daily activities. In the U.S the financial implications of dry eye management was estimated to be US$ 11,302 per patient and US$ 55 billion overall according to a report.

There is no cure for dry eye disease currently and treatment options include topical medication, punctal plugs, practitioner visits, and nutritional supplements, these options are highly inadequate and hence the need for novel solutions. The prevalence of dry eye ranged from 5 to 30% of individuals aged over 50 according to an estimate by The Epidemiology Subcommittee of the 2007 DEWS.

report by Transparency Market Research projects that the industry will be worth $7,780M by 2025 growing at a CAGR of 4.5%.A rising geriatric population, coupled with increased screen exposure, diabetes, environmental factors such as pollution and refractive surgeries are leading to a rise in the incidences of dry eyes, while the lack of adequate therapeutic options, expensive medication along with lack of patient adherence is a challenge for the growth of the market.

However, the market is poised for change with some novel technologies and drug candidates being developed for the treatment of this chronic disorder. We take a look at some promising therapeutics in the offing.

Aldeyra’s lead product candidate is reproxalap, a small molecule RASP (Reactive Aldehyde Species) inhibitor that is intended for the treatment of dry eye disease and allergic conjunctivitis. The Company is also developing ADX-2191 (Dihydrofolate Reductase) and ADX-1612(Protein Chaperone) for Cancer, autoimmune diseases, Proliferative Vitreoretinopathy, Primary Vitreoretinal Lymphoma, retinal disease and SARS-CoV2 Antiviral. These three distinct biological mechanisms of actions mentioned above, have shown the potential to reduce levels of pathological inflammation, through down-regulation of immune cell activation or proliferation.

The Company seeks to leverage its understanding of Reactive Aldehyde Species (RASP) levels to tackle Intracellular inflammatory factors including NF-kB, a prominent protein in the inflammatory response. Its reproxalap can bind to free aldehydes triggering a covalent reproxalap-aldehyde adducts that can degrade intracellularly within hours with significant lowering of aldehyde levels. The candidate has undergone five Phase 2 clinical trials in dry eye disease and allergic conjunctivitis and has shown statistically significant and clinically relevant improvements in ichthyosis (a severe skin disorder) caused by Sjögren-Larsson Syndrome.

Furthermore the company has discovered additional RASP inhibitors namely ADX-103 and ADX-629, which are targeting retinal disease and autoimmune disease respectively. Aldeyra has entered into a partnership with Janssen, for developing RASP inhibitors for systemic inflammatory diseases.

Image Source: Company

The company has acquired Helio Vision for its Phase 3 ready ADX-2191, an intravitreal DHFR inhibitor, for proliferative vitreoretinopathy (PVR). ADX-2191 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the prevention of PVR. In addition, the Company in-licensed two clinical-stage candidates namely ADX-1612 and ADX-1615 (an oral pro-drug of ADX-1612) and is developing them for the treatment of various inflammatory diseases.

Key Remarks

  • Aldeyra has three potential catalysts in 2021, beginning with the enrollment of the TRANQUILITY main cohort that will commence in February 2021, followed by the release of the topline results from Phase 3 INVIGORATE Trial in allergic conjunctivitis in the second half of the year. The Company will also have the Phase 2 clinical testing results for ADX-629 that is being developed for the treatment of systemic diseases.
  • Analysts estimate that Reproxalap may be successfully commercialized by FY 2022-2023 and the total sales are expected to grow by 75 percent CAGR from $36M in 2022 to $1.03B by 2028. The candidate’s specialty is its quick onset of action which is the need of the hour in the treatment of dry eye syndrome, however the four times dosing regimen may hamper patient compliance.
  • The Company raised over $74.7 million through a public offering in January 2021, these funds along with $86.2 million in Cash, cash equivalents and marketable securities (as of September 2020) will be sufficient to fund its trials and operations until 2023.
  • Clinical trials are fraught with risk and uncertainty. The Company is focused on leveraging the therapeutic potential of RASP inhibitors for the treatment of a host of diseases, but setbacks in clinical trials may have a negative impact on the Company. However, a diversified pipeline mitigates the risk associated with failures by diversifying its risk and making optimal use of its resources.
  • 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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