Recently Listed Nyrada is Improving Lives and Providing Hope Through Innovation in Drug Development

US-registered Nyrada Inc is a biopharmaceutical company focussed on discovery and early phase drug development. It listed on the Australian Securities Exchange on 16 January 2020 (ASX: NYR) and the IPO offer was fully subscribed, raising A$8.5 million.

Nyrada’s mission is to develop innovative treatments in therapeutic areas where there is unmet clinical need and large market potential. The business model is to commercialise early, following initial confirmation of safety and efficacy in the target population. Nyrada has a diverse pipeline across broad therapeutic areas and its two lead programs are in the cardiovascular disease and brain injury sectors.

Leading Drug Development Programs

Cardiovascular Program

Nyrada’s cholesterol-lowering cardiovascular program is aimed at providing a single pill treatment to lower high LDL Cholesterol and prevent cardiovascular disease. The drug development objective is to combine a novel small molecule PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor with a generic statin to produce a single tablet. The mechanism of action for the drug is to inhibit the plasma protein PCSK9, which has a key function in regulating the level of LDL cholesterol in the blood.

Scope for Cholesterol-Lowering Solution

According to the company, a total of 62.6 million US adults have elevated LDL-C and of those, around 27.4 million take a statin. However, 19.4 million are unable to achieve an LDL-C target despite making lifestyle changes and taking statin therapy. By combining a small molecule PCSK9 inhibitor with a statin, Nyrada aims to enable patients to reach their target LDL-C level with a convenient and cost-effective “single pill” treatment. The treatment will also be attractive to those taking statins alone who experience tolerance issues on their optimal dose, and those taking statins who would simply prefer for a more effective treatment. The global statin market in 2017 was estimated to be worth US$19 billion.

The current treatment options are suboptimal in terms of efficacy when used as a monotherapy. One available treatment option is to combine a statin with a monoclonal PCSK9 inhibitor. This solution, although effective, is expensive as well as inconvenient for patients who are faced with taking a pill plus a regular injection. The newly approved oral treatment Nexletol (Esperion) was developed for use with a statin and is expected to be launched in late March 2020. Clinical studies for this drug have shown the LDL-C reduction over statin alone is modest (approx. 18%) and adequate for only those patients taking statin therapy who are close to reaching their LDL-C target.

Nyrada’s Unique Cholesterol-Lowering Solution

Nyrada has directed its efforts towards a small molecule PCSK9 inhibitor (PCSK9i), facilitating the development of a single pill solution for the effective lowering of high LDL cholesterol. The novel target medication would provide a cost-effective and convenient solution to the cholesterol problem as the drug would be taken orally, once daily.

Nyrada has submitted composition of matter patent applications that protect its small molecule PCSK9 technology and these have progressed to the national phase of review.

The unique elements of the target drug include the following:

  • Small molecule PCSK9 inhibitor + statin enables a single pill treatment for high LDL-C.
  • Offers a potential effective treatment for patients intolerant of high-dose statin therapy

Publication of Nyrada’s Significant PCSK9i Advancement

The peer-reviewed scientific journal Bioorganic & Medicinal Chemistry recently highlighted the following achievements:

  • Nyrada PCSK9i compounds lower blood cholesterol levels in an in vivo model and restore LDL cholesterol capture by human cells, providing proof-of-concept that a small molecule inhibitor against PCSK9 is therapeutically viable.
  • Potential for an oral therapy to accompany a statin opens as Nyrada overcomes the enduring pharmaceutical challenge of designing a small molecule inhibitor of PCSK9.

Nyrada is currently optimising the oral bioavailability and PCSK9-binding potency of its lead candidate before advancing it into preclinical safety and toxicology testing, ahead of a first-in-human clinical study.

Neuroprotection Program

Integral to Nyrada’s neuroprotection program is the development of intravenous and intranasal dosage forms for the prevention the secondary brain injury that occurs following stroke or traumatic brain injury (TBI).

The primary objective of this solution is to limit the number of brain cells that die post-injury, thereby decreasing functional deficits (motor, memory, cognitive function) and improving long-term outcomes for patients. According to the company, around 60% of the patients surviving stroke experience a permanent disability that requires long-term assisted living.

The mechanism for achieving this is by inhibiting Ca2+ induced excitotoxicity which is the pathological process by which neurons are damaged and killed by the overactivations of receptors for the excitatory neurotransmitter glutamate. Nyrada’s neuroprotectant drug would be administered for 3-5 days post brain injury, aiming to prevent excitotoxicity, a key driver of secondary brain damage.

In the days following brain injury, the area of damage (infarct) expands. Nyrada’s brain injury solution aims to restrict injury size and associated damage, with an aim to improve patient outcomes.

Besides stroke and traumatic brain injury being a major health issue in the civilian population, the program holds also has significant relevance to the armed forces where blast injuries are common. Finding an effective treatment of traumatic brain injury is a stated key health priority for the US Department of Defence.

Market Opportunity for Neuroprotection Program

The magnitude of the brain injury problem is evident in the statistics. Each year in the US approximately 2.8 million people sustain a TBI, resulting in 280,000 hospital admissions. For stroke the annual figure is 800,000 occurrences, resulting in 650,000 emergency room visits. The one drug class available to treat stroke - tissue plasminogen activator, or tPA - is suitable for less than 15% of patients due to the short 4.5 hr therapeutic window. Furthermore, neurology/physical rehabilitation are the only existing therapies currently available to treat patients who sustain a TBI.

With stroke and TBI combined, approximately 700,000 patients seek hospital treatment annually in the US, a statistic that represents a major opportunity for an effective neuroprotectant drug.

Other Drug development Programs

Neuropathic Pain Program

Nyrada is also working towards the development of a drug for peripheral neuropathy. Often, an injury or inflammation of the peripheral nerves become chronic, leading to persistent pain or loss of function. Nyrada is developing a treatment for neuropathic pain associated with spinal nerve compression (e.g. sciatica).

The global neuropathic pain market is worth US$5.5 billion and is forecasted to grow at the CAGR of 5.5% during 2017-2023, according to Nyrada.

Autoimmunity Program

The company’s Autoimmune Disease Program encapsulates developing a treatment for psoriasis which occurs when the body’s cells are mistakenly attacked by the immune system.

Nyrada’s psoriasis treatment involves the development of an IRAK4 inhibitor which can be applied as a topical cream or orally taken as a tablet.

Current medications for psoriasis include Tremfya (Janssen), Humira (AbbVie), and Skyrizi (AbbVie) monoclonal antibodies and these are required to be injected after every eight to twelve weeks. Despite the effectiveness of these drugs, their high cost, inconvenience, and associated discomfort make them a suboptimal treatment option for many psoriasis sufferers.

Current Status of Company’s Programs

  • Proof-of-concept established for cardiovascular and neuroprotection programs
  • Composition of matter patents lodged for both the programs.
  • Target timeframes for first-in-human phase I studies established.

Tapping large, under-served therapeutic areas, compelling proof of concept data and right team to execute, Nyrada’s clinical programs for cholesterol-lowering and neuroprotection drugs are set to enter clinic in late 2021 and mid-2022, respectively.

NYR settled the day’s trade at A$0.180 on 3 March 2020, up ~2.9%.

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