Autistic Disorder Pipeline Insight Report 2023 | Major Companies- Scioto Biosciences, ACADIA Pharmaceuticals Inc., and others

DelveInsight's, "Autistic Disorder Pipeline Insight 2023," report provides comprehensive insights about 25+ companies and 28+ pipeline drugs in Autistic Disorder pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

In the Autistic Disorder Pipeline Report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Autistic disorder collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Key takeaways from the Autistic Disorder Pipeline Report

• DelveInsight's Autistic Disorder Pipeline report depicts a robust space with 25+ active players working to develop 28+ pipeline therapies for autistic disorder treatment.

• The leading Autistic Disorder Companies include Scioto Biosciences, ACADIA Pharmaceuticals Inc., Yamo Pharmaceuticals LLC, Stalicla SA, MapLight Therapeutics, Jazz Pharmaceuticals, and others.

• Promising Autistic Disorder Pipeline include SB 121, Pimavanserin, FEN164, L1-79, ML-004, GWP42003-P, STP1, NTI164, AB-2004, RO7017773, INP105, PAX-101, SCI-210, Autologous MSC-NTF, ENT-01, MT 1988, IAMA-6, IAMA 097, MRx0006, and others.

• The Autistic Disorder Companies and academics are working to assess challenges and seek opportunities that could influence Autistic Disorder R&D. The therapies under development are focused on novel approaches for Autistic Disorder.

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Autistic Disorder Overview
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social communication and the presence of restricted interests and repetitive behaviors. There is no clear-cut pathology of ASD however different populations have been suggested for different subtypes of ASD.

Recent Developmental Activities in the Autistic Disorder Treatment Landscape

• In February 2023, PaxMedica, Inc., for the treatment of disorders with intractable neurologic symptoms, announced that the Company has signed a funding agreement for net proceeds of $3.2 million with Lind Global Partners II, LP, an investment fund managed by The Lind Partners, a New York based institutional fund manager (together "Lind"). This funding will give the flexibility to progress on the work PaxMedica are doing for the development of the autism spectrum disorder (ASD) indication for PAX-101. PaxMedica appreciates the Lind Group's support for work to find treatments for disorders with intractable neurologic symptoms such as ASD.

• In January 2023, SciSparc Ltd. announced it had signed an agreement with the Soroka University Medical Center, in Be'er-Sheva, Israel ("Soroka Medical Center") to conduct the Company's clinical study for SCI-210 in patients suffering from autism spectrum disorder ("ASD").

• In July 2022, Impel Pharmaceuticals announced the first subject had been dosed in a Phase IIa proof-of-concept study of INP105, nasal olanzapine, a widely used atypical, second-generation antipsychotic. INP105 is being developed as an acute treatment for agitation in persons with autism spectrum disorder (ASD) using Impel's proprietary Precision Olfactory Delivery (POD®) technology which delivers drugs to the upper nasal space.

• In May 2022, Scioto Biosciences, Inc. (Scioto) announced top-line results of its Phase Ib trial of lead asset SB-121, based on its novel microbiome delivery platform, Activated Bacterial Therapeutics (ABT), which is designed to deliver best-in-class, live therapeutic bacteria to the gut. This first-in-human study was a randomized, double-blind, placebo-controlled, 28-day daily-dose crossover study of the safety and tolerability of SB-121 (Lactobacillus reuteri with dextran microparticles and maltose) in patients ages 15 to 45 years, diagnosed with autism spectrum disorder (ASD).

• In February 2022, Axial Therapeutics announced the publication in Nature Medicine of full results from its Phase Ib/IIa clinical trial of AB-2004. AB-2004 was shown to have strong safety and tolerability across all dose levels, and no drug-related serious adverse events were identified. AB-2004 reduced anxiety and irritability based on scores on the Aberrant Behavior Checklist - Irritability domain (ABC-I) and the Pediatric Anxiety Rating Scale (PARS). Individuals with high baseline irritability (scores ≥ 15), which represents the top quartile of severity, displayed a greater than 9-point decrease in ABC-I over 8 weeks.

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Autistic Disorder Emerging Drugs Profile

• CM-AT: Curemark
CM-AT is designed to enhance protein digestion thereby potentially restoring the pool of essential amino acids. Essential amino acids play a critical role in the expression of several genes important to neurological function and serve as precursors to key neurotransmitters such as serotonin and dopamine. CM-AT, has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA). FDA has also granted Curemark a rolling review of its New Drug Application for CM-AT.

• L1-79: Yamo pharmaceuticals
L1-79 is an investigational drug currently in clinical development by Yamo Pharmaceuticals for the treatment of the core symptoms of ASD. L1-79 was granted Fast Track Designation by the Food and Drug Administration in May of 2018. It acts as a tyrosine hydroxylase inhibitor and is expected to modulate the catecholaminergic pathways implicated in ASD. L1-79 reported positive results from Phase II study in November 2021. Clinical studies are planned to further investigate the potential of L1-79 to improve the core symptoms of ASD.

Autistic Disorder Pipeline Therapeutics Assessment
There are approx. 25+ key companies which are developing the Autistic Disorder. The companies which have their Autistic Disorder drug candidates in the most advanced stage, i.e. preregistration include, Curemark.

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Scope of the Autistic Disorder Pipeline

• Coverage- Global

• Autistic Disorder Companies- Scioto Biosciences, ACADIA Pharmaceuticals Inc., Yamo Pharmaceuticals LLC, Stalicla SA, MapLight Therapeutics, Jazz Pharmaceuticals, and others.

• Autistic Disorder Pipeline- SB 121, Pimavanserin, FEN164, L1-79, ML-004, GWP42003-P, STP1, NTI164, AB-2004, RO7017773, INP105, PAX-101, SCI-210, Autologous MSC-NTF, ENT-01, MT 1988, IAMA-6, IAMA 097, MRx0006, and others

• Autistic Disorder Pipeline Segmentation: Product Type, Molecule Type, Route of Administration

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Table of Content
1. Introduction
2. Executive Summary
3. Autistic disorder: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Autistic Disorder- DelveInsight's Analytical Perspective
7. Late Stage Products (Preregistration)
8. CM-AT: Curemark
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. L1-79: Yamo pharmaceuticals
12. Drug profiles in the detailed report…..
13. Early stage products (Phase I)
14. SB-121: Scioto Biosciences
15. Drug profiles in the detailed report…..
16. Inactive Products
17. Autistic disorder- Unmet Needs
18. Autistic disorder- Market Drivers and Barriers
19. Appendix

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