Strong Pipeline of Drugs for Treatment Of Psychotic Disorders Anticipated To Drive The Market Through 2028

PALM BEACH,  Fla., Oct. 11, 2021 /PRNewswire/ -- There is a high demand for more advanced products for the treatment and maintenance of severe mental disorders. Thus, pharmaceutical companies are investing a huge amount of money for novel drug R&D and launches for psychiatric and neurological disorders. The development and discovery of new mental disorders drugs have gained valuable impetus in recent years. Drug makers are moving from conventional drug formulations to the discovery of innovative and improved medications to treat a variety of mental disorders within the mental disorder care industries. A report from Grand View Research said that the global central nervous system therapeutic market size, which was valued at 116.2 billion in 2020, is expected to reach USD 205.0 billion by 2028. It added that high unmet medical needs and government initiatives to reduce the disease burden are driving the market for central nervous system therapeutics over the forecast period.  The report continued saying: "The market holds strong future growth opportunities and major players are adopting different marketing strategies such as new product development, collaborations, geographic expansion, mergers and acquisitions, and new product approval, to strengthen their positions. … for the development of drug candidates applicable across a wide range of neurological diseases.  Active Biotechs in the markets today include:  Pasithea Therapeutics Corp. (NASDAQ: KTTA), COMPASS Pathways plc (NASDAQ: CMPS), Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP), Cybin Inc. (NYSE: CYBN), atai Life Sciences (NASDAQ: ATAI).

Grand View Research continued with:  "Presence of strong pipeline products by major pharmaceutical companies … are expected to accelerate market growth over the forecast period. Besides, other pharmaceutical companies are also actively involved in the development of novel therapies and investing heavily to develop effective therapeutics for the treatment of CNS associated diseases… Pharmaceutical companies are adopting strategies such as product development, merger and acquisition, and collaboration to strengthen their position in market.  The presence of strong pipeline products is expected to propel the market for central nervous system therapeutics over the forecast period. The key pharmaceutical players are focusing on new therapies to prevent or improve the symptoms of neurological disorders… Mental health was estimated to be the second-largest segment in the central nervous system therapeutic market. High patient base of anxiety disorder and epilepsy are the major growth contributors. Moreover, the presence of strong pipeline drugs for the treatment of psychotic disorders is anticipated to drive the market for central nervous system therapeutic at a lucrative rate over the forecast period."

Pasithea Therapeutics Corp. (NASDAQ: KTTA) Breaking News: Pasithea Therapeutics Corp. and Evotec SE Enter into Drug Development Agreement – Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced the initiation of a new chemical entity ("NCE") development program and named Evotec as its NCE research partner.

"We are delighted to be working with Evotec, one of the largest and most well-respected drug discovery and development companies in the world, to progress our first compound. This is a significant step on our drug development path to ultimately develop new molecular entities to improve the lives of those suffering with brain disorders. Pasithea aims to advance small molecule therapeutics with a focus on a specific neuroinflammatory pathway implicated in the neurobiology of depression and schizophrenia," stated Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea Therapeutics.

"Evotec has a proven track record of adding value to its partners' research by providing innovative and flexible solutions from target compound through to preclinical candidate. This is an important initial step forward for our program, and we believe that Evotec's high-quality science and scientific execution will expedite and increase the chances of progressing our drug candidate to the clinic," stated Prof. Lawrence Steinman, Chairman of Pasithea Therapeutics.

"Pasithea is pursuing an exciting approach to target the improvement of mental health," stated Christophe Muller, PhD, Global Head of Business Development, Evotec SE. "With our fully integrated suite of the highest quality capabilities, Evotec is uniquely equipped to facilitate the discovery and development of innovative  programmes to the clinic and beyond. We are delighted to support Pasithea in addressing the very important area of mental health and look forward to working closely with the team to assist them in reaching their goal of tackling brain disorders."  Read the Pasithea Therapeutics full press release by going to:  https://ir.pasithea.com/

In other biotech news in the markets this week: 

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, recently announced that it has acquired an intellectual property (IP) portfolio including patent applications covering a variety of psychedelic and empathogenic substances. The IP was developed together with inventor Matthias Grill PhD, founder and CEO of MiHKAL GmbH in Basel, Switzerland, who will be working with COMPASS on an exclusive research project to develop new product candidates.

The substances covered in the IP portfolio include a variety of psychedelic and empathogenic compounds, some of which are prodrugs - pharmacologically inactive compounds which are metabolised inside the body to produce an active drug. The new substances include novel derivatives of known compounds, increasing the confidence in therapeutic effects and safety profile while offering optimised characteristics.

Field Trip Health Ltd. (NASDAQ: FTRP) (TSX: FTRP), a global leader in the development and delivery of psychedelic therapies, recently announced the lead indications for FT-104, its novel psychedelic compound in development, will be Treatment Resistant Depression (TRD) and Postpartum Depression (PPD). Field Trip today also announced that Anita H. Clayton, MD, Chair of Psychiatry and Neurobehavioral Sciences at the School of Medicine at the University of Virginia, has joined its Scientific Advisory board.

Through Field Trip Discovery, its drug development division, Field Trip is developing next-generation psychedelic molecules. Its first molecule in development, FT-104, a prodrug, is a synthetic serotonin-2A (5HT2A) agonist whose active component has serotonin-2A potency similar to psilocybin. Importantly, however, the active component of FT-104 is expected to produce a reliably shorter duration of psychoactivity (2-3 hours) than psilocybin, and has high bioavailability after administration.

Cybin Inc. (NYSE American: CYBN), a biotechnology company focused on psychedelic pharmaceutical therapies, recently announced that Adelia Therapeutics Inc. ("Adelia"), a wholly-controlled subsidiary of Cybin, has achieved those milestones identified as Year 2 Q1 (i)-(iii), as contemplated by the terms of a contribution agreement dated December 4, 2020 (the "Transaction Agreement") among Cybin, Cybin Corp., Cybin US Holdings Inc. (the "Acquiror"), a wholly-controlled subsidiary of Cybin, and all of the previous shareholders of Adelia (the "Adelia Shareholders").

Pursuant to the terms of the Transaction Agreement, Class B common shares in the capital of the Acquiror (the "Class B Shares") shall be issued to the Adelia Shareholders, in satisfaction of the $706,586.69 (approximately US$560,181.93) due to them on meeting a portion of the relevant milestones, at an effective issue price determined in accordance with the Transaction Agreement and applicable securities law. The Class B Shares issued by the Acquiror to the Adelia Shareholders are exchangeable for common shares in the capital of Cybin (the "Cybin Shares") on a 10 Cybin Shares for 1 Class B Share basis, at the option of the holder thereof, subject to customary adjustments. No Class B Shares are exchangeable prior to December 14, 2021, and not more than: (i) 33 1/3% of the Class B Shares will be exchangeable prior to December 14, 2022; (ii) 66 2/3% of the Class B Shares will be exchangeable prior to December 14, 2023; and (iii) thereafter, 100% of the Class B Shares will be exchangeable.

DemeRx IB, Inc., an atai Life Sciences (NASDAQ: ATAI), a platform company focused on developing ibogaine for the treatment of opioid use disorder (OUD), recently announced that the first subjects have been dosed in a Phase 1/2a clinical trial of ibogaine HCl (DMX-1002). The trial has commenced enrollment and dosing of recreational drug users and healthy volunteers in the Phase 1 segment of the study at the Manchester clinical unit of MAC Clinical Research (MAC) in the UK, one of Europe's largest clinical development organizations.

DMX-1002 is an oral formulation of ibogaine, a naturally occurring psychedelic product isolated from a West African shrub. In previously published non-controlled studies, ibogaine has demonstrated rapid and sustained efficacy in treating OUD and has the potential to be a disease modifying treatment for this vulnerable patient population seeking to end their intractable cycle of drug dependence.  The Phase 1/2a trial is designed to assess safety, tolerability, pharmacokinetics, and efficacy, and the results will inform future studies in patients with opioid use disorder. We expect to obtain safety data from the phase 1 segment of this trial in early 2022.

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