Posted by Varun Renjen, M.D., Jose Quejada, Ph.D., Andreea Cretu, Dr.Sc. on January 4th, 2022.
Just over a year ago, we wrote a two-part series on the “quiet revolution” that’s going on in CNS therapies (access part I here and part II here). The exciting developments in oncology may be grabbing the headlines, but very interesting things are happening in CNS and much of it has flown just under the popular culture’s radar. In that series of papers, we made a few predictions about what might happen during 2021 and how the CNS market was likely to evolve.
Well, we thought it might be interesting to hold ourselves accountable. So, in this article, we look back at our predictions for 2021 and see how good they were. Overall, we think our crystal ball was pretty clear. Alas, it wasn’t perfect, and we did have a miss or two. Below, we explore those predictions. We also polish up the crystal ball and take a look ahead at 2022, offering a few more.
A Look Back at Predictions for 2021
Prediction for 2021: Biogen must do more deals to bolster their pipeline.
As we predicted, Biogen did complete more deals in 2021, bolstering their R&D capabilities and their pipeline of late-stage therapeutics. Several of those deals align with the areas of interest highlighted in our previous papers.
For example, Biogen completed RNAi deals with Mirmus, Inc., Evisagenics, and Atalanta Therapeutics. The company also completed late-stage drug development deals with Bio-Thera Solutions (for a proposed biosimilar to tocilizumab) and InnoCare pharma (orelabrutinib for multiple sclerosis). In addition, it completed gene therapy deals with companies like Capsigen, Cevec Pharma, and ViGeneron GmbH. The latter two specifically leveraging adeno associated anti-viral vectors.
Prediction for 2021: The amyloid hypothesis will fail.
Our biggest miss stemmed from the conditional approval of Aduhelm® (aducanumab) by the US FDA in June. But then again, that one caught nearly everyone by surprise. However, the EMA has recommended a refusal for a marketing authorization for aducanumab and Japan has also refused it, so the FDA remains the only approval for the product.
At any rate, bolstered by the FDA’s approval, the market has seen increased enthusiasm from other amyloid beta drugs such as donanemab (Eli Lilly), lecanemab (Biogen/Eisai), and gantenerumab (Roche) with primary completion dates in the late 2022 / early 2023 time frame.
It’s worth noting that gantenerumab will likely be priced lower than Aduhelm and offers a more convenient route of administration (i.e. subcutaneous). This differentiating factor may simplify the drug’s distribution, untangling a significant roadblock associated with IV-based treatments. Eli Lilly has received accelerated FDA review for donanemab and is planning a head-to-dead comparison against Aduhelm.
Prediction for 2021: Alternative approaches to treating Alzheimer’s disease will advance.
OK, so this prediction didn’t really require us to “go out on a limb,” but it was correct with important developments in drugs with alternative mechanisms of action. Notably, Novo Nordisk initiated a phase 3 clinical trial of semaglutide (an anti-diabetic medication) in patients with early Alzheimer’s disease. This therapy aims to test the notion that Alzheimer’s is basically “type 3 diabetes.” In addition, Neuronascent published positive topline phase 1 results from its drug NNI-362 that aims to reverse the cognitive decline caused by Alzheimer’s.
Duchenne Muscular Dystrophy (DMD)
Prediction for 2021: Smaller clinical trials will continue but may need to show more data to get approved. The competition for DMD will heighten and Sarepta’s SRP-9001 needs to continue to generate positive data. Failing this, they may lose their foothold in the market to Pfizer and/or Solid Biosciences.
Sarepta continued its successful journey in DMD and keeps a strong foothold in the market. In February 2021, the FDA provided conditional approval for Amondys 45—Sarepta’s third DMD drug—based on data from 43 patients. Similar to Vyondys 53 and Exondys 51, Amondys 45 will need to provide additional efficacy data. However, this time the FDA process was relatively quick and with no controversy. Additionally, Sarepta published positive data from two of their SRP-9001 trials (77 patients in total) and announced the initiation of a phase 3 double-blind trial in US, Europe, and Asia.
Other players are currently moving slower and/or have faced some difficulties:
- Pfizer, currently running its first placebo-controlled study in DMD, had to exclude certain patients from its phase 3 trial after an unexpected immune response was observed.
- Solid Biosciences reported positive data from its phase I/II trial but no announcements have been made regarding the initiation of a phase III trial yet.
Prediction for 2021: We will see continued investment growth in “taboo” psychedelic based treatments for psychiatric disorders.
This prediction was also correct. As we later detailed in our paper on “taboo” treatments, many exciting things are currently happening in this space. In particular, five prominent psychedelics companies (Compass Pathways, MindMed, ATAI Life Sciences, FieldTrip, and Numinus Wellness) all went public since late 2020 and are actively developing mental healthcare treatments.
Prediction for 2021: Smaller companies that are heavily invested in CNS could sink or swim during 2021.
We had predicted that 2021 could be a “make or break” year for a number of smaller companies focused on CNS. The reality wasn’t quite that dramatic, as the companies we mentioned continued to advance, if slowly. Some examples include:
- Axsome Therapeutics: The company’s PDUFA meeting for AXS-05 has been delayed for unknown reasons so it will likely have PDUFA meetings for both AXS-05 and AXS-07 in the first half of 2022.  
- ACADIA pharmaceuticals: The FDA did not approve their supplemental NDA for the treatment of dementia-related psychosis. It appears the therapy will be refiled with a narrower label.
- Cerevance: CNV058 showed positive phase 1b results. However, no information regarding the initiation of a phase 2 study has been made public (as of this writing).
- Praxis: The clinical hold for PRAX-114 in major depressive disorder was lifted in March 2021 and the company continued their phase 2/3 study. Praxis also initiated an additional phase 2 study as adjunctive therapy and is expecting results in the first half of 2022.
Prediction for 2021: Driven in part by the ongoing COVID-19 pandemic, the use of digital therapeutics supporting psychiatric disorders will continue to grow.
As the global pandemic winds through its second year, digital therapeutics have captured a lot of interest in the psychiatric space. These range from internet-based cognitive behavioral programs to stimulation devices and more. A few examples include:
- Pear Therapeutics received FDA breakthrough approval for its device aimed at treating alcohol use disorder. The company has commercialized three other digital therapeutics (reSET, reSET-O, and Somryst) and has 14 products in clinical development.
- Eli Lilly launched an initiative called Think Talk Treat Migraine™ to help improve the diagnosis and treatment of the disease. This includes a digital migraine management platform called VEGATM, allowing patients to log, visualize, and communicate symptoms to their healthcare providers.
- Theranica received FDA approval for its device, Nerivio® for acute treatment of migraine in adolescents
- UK innovator ieso closed a series B financing ($53 million) to develop digital therapeutics using AI for assessment and precision treatment of mental health disorders.
- A general boost has also been observed in the use of virtual mental health counselling via video chat. In fact, over 40% of health insurers are even considering adding these services to their benefit plans. Additionally, with the launch of the FDA’s Digital Health Center of Excellence in September 2020, the agency showed its openness to support innovation and safe access to digital tools.
Prediction for 2021: Given the opioid situation, most of the action in this space will focus on non-opioid treatments for pain or therapies for opioid use dependency (OUD).
We saw continued investment growth in the pain segment, very much along the lines we expected. AppliedVR provides an illustrative example. It raised $29 million in funding to pursue FDA approval for its virtual reality tool that uses cognitive behavioral therapy (CBT) for pain management. The therapy, called EaseVRx, had already received Breakthrough Device Designation for treatment-resistant fibromyalgia and chronic intractable lower back pain. We expect this trend away from opioids to continue.
Prediction for 2021: There will be continued investment into gene therapies as bigger companies move more resources into the space. Smaller biotechs will continue receive substantial investment dollars.
By August 2021, cell and gene therapy companies saw more than $13.6 billion invested, with the majority ($7.86 billion) coming from venture capital or private equity firms. Also, bigger companies did boost their positions, as we expected. Outside of Biogen’s investments into RNAi and AAV technologies (mentioned previously), other important moves included:
- Eli Lilly’s investment into MinA therapeutics for $15 million for up to five undisclosed targets
- AbbVie’s $140 million deal with Capsidia (in addition to $50 million in series A financing)
- Astellas’ deal with Dyno therapeutics for a potential total of $1.6 billion focused on designing better capsids for AAV-based treatments
- Bayer’s plans for a $200 million cell therapy manufacturing facility, following on the heels of its entry into cell and gene therapy in 2020
Also of note, The FDA—together with 27 public and private organizations—launched the Bespoke Gene Therapy Consortium (BGTC). It aims to optimize and streamline the development of gene therapies for rare diseases. This initiative will bring great benefits to the companies allowing them to reduce clinical development costs and hopefully get new drugs to all patients in need faster.
Predictions for 2022
Prediction: We will begin to see treatments targeted at the neurological symptoms associated with COVID.
As COVID-19 pandemic continues, we are gaining visibility into the longer-term neurological issues that can surface as a result. In fact, more than 80% of hospitalized COVID-19 patients experience neurological symptoms at some point in their disease. For example, 48% of respondents in a 27,000-patient study reported smell and taste disorders. The large majority (up to 96%) experienced those disorders temporarily. The other 4%, however, seem to have long-lasting issues. Even though the percentage is low, the sheer numbers of patients involved globally can make this a large market.
Other neurological effects that have been reported include:
- Cerebrovascular disease (stroke)
- Anxiety, depression, and other psychiatric illnesses (in December of 2020, the US Census Bureau reported symptoms of anxiety in 42% of respondents, up from 11% the year before.)
- Increased issues with attention and memory
- Potentially, a link to Parkinson’s disease
We are beginning to see research into new treatments for these COVID-related illnesses. Interestingly, this is going beyond COVID patients and is actually extending to include the doctors and nurses who treat them. Cybin recently announced that the FDA has authorized an investigator-initiated trial for a phase 2 study evaluating psychedelic-assisted psychotherapy (using psilocybin) for frontline clinicians experiencing COVID-related distress (e.g., depression, anxiety, “burnout,” and PTSD). During 2022, we will see more attention and research into COVID-related neurological issues.
“Taboo” Medications / Psychedelics
Prediction: There will be continued investment into the psychedelic space but it may overheat and experience a slight “crunch”, especially as reality sets in and investors realize that psychedelics are not a panacea.
Of course, there is reason to be optimistic about the promise of psychedelic-based therapies. There is a lot of excitement in the space right now, but history tells us that excitement in any “hot” area tends to wane after the initial rush begins to wear off. We could see that happen in psychedelics, but it’s an open question as to when.
Currently, there’s plenty of heat in the space. The positive phase 3 results from MAPS using MDMA to treat PTSD have added fuel to the fire, and expectations are high. In 2027, the psychedelics field is expected to earn $6.85 billion.
Other examples of the interest in psychedelics include ATAI Life Sciences with its $254 million initial public offering in 2021, as well as COMPASS Pathways’ $146 million IPO. That IPO was followed by a $144 million secondary offering in April 2021. During the first 4 months of 2021 alone, venture capital firms invested $329 million in biotech firms focusing on psychedelic therapies.
Prediction: As we wait for the first psychedelic drugs to be approved, we will see a lot of movement in psychedelics preparing the market.
Interestingly, these investments will not be solely focused on the pharmaceutical companies developing the therapies, but diversified over the entire supply chain from raw materials to clinics. This not only diversifies the risk associated with investing, but also helps prepare the market to manufacture, distribute, deliver, and administer these products once they’re approved.
Prediction: The patent debate will rage on in 2022, defining the feasibility of the psychedelic treatment landscape.
In October of 2021, COMPASS Pathways was granted its fourth patent by the US Patent and Trademark Office (USPTO) for Form A hydrate psilocybin. This was met with some backlash from scientists, journalists, lawyers, indigenous communities, and patient advocates. Their claim is that such patents are exploitative of indigenous knowledge without acknowledgement or due compensation. As these substances are derived from natural products and have been used in medical practice for decades (or even centuries), many say they lack the novelty required to justify patent protection.
Moving forward, the USPTO’s management of this issue will be interesting. Their reaction to these claims—and their subsequent policies regarding issuing patents—could significantly affect investment in the field.
Prediction: The psychedelic treatment paradigm will gain a stronger foothold in academic circles as renowned centers have increasingly been establishing centers dedicated to psychedelic research.
In the US, the number of academic centers studying psychedelics tripled in 2021. At the beginning of the year, there were two centers in existence: one at Johns Hopkins University and the other at UC Berkeley. Now, there are six. New centers were established at NYU, Mount Sinai Hospital, Mass General Hospital, and the University of Wisconsin Madison. Globally, other centers exist at Imperial College London, King’s College, Manchester University, and Maastricht University.
This trend demonstrates the growing acceptance of psychedelic therapies. Over medium- to long-term, this acceptance should bolster the R&D pipeline, help facilitate clinical trials, and expand the training of administering psychiatrists. To note, there are important holdouts, such as Dr. Jeffrey Lieberman, Chairman of the Department of Psychiatry at the Columbia University College of Physicians and Surgeons.
Prediction: There will be increased activity in Parkinson’s disease research focused on both disease-modifying therapies and the treatment of symptoms.
The protein alpha-synuclein is thought to trigger Parkinson’s disease through misfolding and forming toxic aggregates leading to neuronal death. Existing treatments for Parkinson’s are focused on the disease’s symptoms and not its underlying causes. There is a strong unmet need for disease-modifying therapies in the space.
However, several potentially disease-modifying treatments are being studied. For example:
- Gain Therapeutics – GT-02287 and GT-02329
- Anavex Life Sciences – Anavex 2-73
- BIAL Biotech – BIA 28-6156 / LTI-291
- Prevail Therapeutics (acquired by Eli Lilly in 2020) – PR001
It will be interesting to monitor the progress of these potential new therapies as the year progresses.
Prediction: Due to the less than optimal performance of Aduhelm®, the Alzheimer’s market will heat up, as it’s ripe for additional treatments and increased competition.
Biogen’s Aduhelm® was controversially approved by the US FDA in June of 2021. Despite its strong first-mover advantage, it has struggled commercially. For example, analysts expected sales to reach $14 million during the third quarter of 2021. The actual results were only $300,000, an extremely disappointing showing.
To start, Aduhelm will not be the only game in town targeting amyloid beta in Alzheimer’s. As mentioned above, new drugs also targeting amyloid beta are being developed by Lilly (donanemab), Roche (gantenerumab), and Biogen/Eisai (lecanemab). Competition in that space will grow substantially.
In addition, research continues in various other mechanisms of action. Notable examples include
- Simufilam (PTI-125) by Cassava Sciences
- ATH1017 by Athira
- Semaglutide (also known as Rybelsus in type II diabetes) by Novo Nordisk.
Research into Alzheimer’s vaccines is also advancing. AC Immune is collaborating with Janssen on a liposome-based vaccine that mimics pathological tau, currently in phase I / II trials. Prothena is working on a vaccine that targets both amyloid beta and tau. That product is currently in preclinical studies.
Prediction: New treatments will aim to undercut Aduhelm pricing.
Aduhelm’s original price ($56,000 per year) has generated a significant amount of backlash. Even the Alzheimer’s Association, a leading advocate for Aduhelm’s approval, was critical of it. Various insurance companies have been unwilling to cover Aduhelm because of its steep price and the clinical data that led to its approval.
Recently, Biogen announced that it would slash Aduhelm’s US price by about 50%, effective January 1, 2022, as Medicare’s coverage decision for Aduhelm approaches. We expect new treatments—especially the fast-follower drugs targeting amyloid beta—to compete by undercutting Aduhelm’s price. Roche (developer of gantenerumab mentioned above) has already announced that its price will be competitive. Its product for multiple sclerosis, Ocrevus®, was priced at 30% below the standard of care, demonstrating Roche’s willingness to undercut competitors. It will be interesting to see how pricing evolves as more competitors enter the space.
Overall Investment Trends: Companies to Watch
In such a dynamic and interesting space, it’s impossible in a relatively short paper to detail every company that’s looking to invest or that could be a recipient of significand investment dollars. However, we will touch on a few below.
Let’s start with a look at big companies who will be looking to invest:
- Pfizer, currently cash rich from their COVID-19 vaccine, will invest in CNS in a big way moving forward despite previously exiting the space.
- Lilly has announced a stand-alone CNS business unit, demonstrating its continued commitment to the space. It has a strong legacy in CNS and is keen to maintain it.
- Novartis will move forward with investments into Parkinson’s disease research.
- J&J is split into consumer health and pharma. Its pharma side is entering a bit of a “golden age” in neuroscience and will be investing heavily.
- Roche / Genentech is heavily focused on MS, SMA, and Huntington’s disease and will continue to expand its CNS portfolio.
- Biogen, which lost another patent for Tecfidera®, will need to diversify its CNS portfolio and will be looking to invest.
Other companies might be on the receiving end of investment:
- Biogen might become more affordable if its valuation continues to drop. To this, recent news pointed to a potential $42B acquisition of Biogen by Samsung (subsequently denied by the latter). Even if news of this deal is inaccurate, the reception of this news (and the subsequent rise and fall in Biogen stock) evidence the market’s openness to this possibility.
- Argenx is another platform-based player that bears watching. It recently announced that the FDA has approved its treatment for generalized myasthenia gravis, VYVGART™ (efgartigimod alfa-fcab).
- Karuna Therapeutics is awaiting results of their phase 3 study of KarXT for schizophrenia. If positive, the drug has blockbuster status and would be of interest to companies in the mental health space.
- Given the increasing interest and competition in the neurodegenerative space, companies may look to invest in Denali Therapeutics for their platform with potential to work across a variety of neurodegenerative diseases.
Clearly, CNS is a broad, diverse, and interesting area. As we’ve said, there is a “quiet revolution” going on in CNS, as biopharma companies and investors ramp up the level of attention and research dollars. That will continue in 2022, and patients will benefit considerably as the years go by.
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