SOM Biotech presents positive Phase 2a data with SOM3355 at the 34th ECNP Congress 2021
~Data show SOM3355 reduces chorea in patients with Huntingdon’s Disease and has a good safety profile~
~SOM3355 discovered through SOM Biotech’s proprietary artificial intelligence-based computational technology SOMAI PRO~
Barcelona, Spain, 4 October 2021 - SOM Biotech, a clinical-stage biopharmaceutical company with a proprietary AI-based drug discovery technology and a focus on orphan diseases of the Central Nervous System, today announces it will be presenting positive Phase 2a data with SOM3355, an oral vesicular monoamine transporter 2 (VMAT2) inhibitor for the symptomatic treatment of chorea movements associated with Huntington’s disease (HD), at the 34th ECNP Congress held from 2-5 October 2021 in Lisbon, Portugal.
HD is an inherited disorder whereby progressive degeneration of brain centers involved in movement can result in chorea, an involuntary, jerky, movement that randomly affects somatic muscles and flows from one part of the body to another. Xenazine (Tetrabenazine), a VMAT2 inhibitor, is currently approved to treat chorea in HD despite severe side-effects including sedation, somnolence, parkinsonism and the risk of depression and suicidality.
Using the Company’s proprietary artificial intelligence-based computational technology (SOMAI PRO), SOM Biotech identified SOM3355 or Bevantolol hydrochloride1 as an alternative VMAT2 inhibitor that could be repositioned to treat chorea in HD and potentially eliminate the severe side effects of Xenazine.. The molecule’s chemical structure differs considerably from Xenazine and SOM3355 is thought to reduce chorea by inhibiting VMAT2 by a different mechanism.
The Phase 2a study was a double-blind, randomized, placebo-controlled study designed to assess the efficacy and safety of SOM3355 in HD patients with chorea. A total of 32 patients were enrolled in the study and randomly assigned to two arms of four sequential six-week periods in which they received placebo and SOM3355 at 100 and 200 mg BID in crossover design.
The study met the primary endpoint, with 57.1% of patients improving in the total maximal chorea (TMC) score by at least two points in any period upon treatment of SOM3355 compared to placebo. Even greater TMC score improvements of three, four, five, and six points compared with placebo were seen with SOM3355 in 28.6%, 25.0%, 17.9%, and 10.7% of the patients, respectively. Overall, SOM3355 was well tolerated with only mild or moderate adverse events, the most frequent explained by the already known side effects of the drug including headache, fatigue, nausea and vomiting.
Dr. Raúl Insa, CEO of SOM Biotech commented: “Huntington’s disease causes a progressive degeneration of nerve cells in the brain and as such, has a massive adverse effect on the quality of patient’s lives, both physically and mentally. There is a huge unmet medical need for new treatment options to treat symptoms of HD, including chorea, and we are very encouraged by the results we have seen thus far. We will continue to progress SOM3355 through the clinic and anticipate starting a Phase 2b trial later this year in order to bring this promising product candidate to patients as soon as possible.”
Details of presentation
Session Title: Dedicated poster session to interact with the presenters
Abstract Title: Proof-of-concept study testing SOM3355 for the treatment of chorea symptoms in Huntington’s disease
Date & Time: Monday 4 October, 12:00-13.00 CET
Presentation Number: P.0426
The full abstract can be viewed here.
About SOM Biotech: SOM Biotech (www.sombiotech.com) – established in 2009 – is a biopharmaceutical company based in Barcelona, Spain. SOM has an extensive portfolio of products that includes drugs for orphan diseases including TTR Amyloidosis, Huntington's disease, Tardive Dyskinesia, Phenylketonuria, Niemann-Pick C, Glioblastoma and Parkinson’s disease. The company engages in accelerated discovery of therapies through a proprietary artificial intelligence-based computational technology (SOMAI PRO) and develops strategic partnerships with major research centers and pharmaceutical companies.
About SOMAI PRO: SOMAI PRO is the Company’s proprietary AI-based drug discovery technology. The Company successfully uses the technology to identify drugs effective for the treatment of a specific disease, to discover new mechanisms of action and new applications for a drug, and to predict the toxicity of the compounds, as well as the molecular scaffolds for new chemical entities. The main strength of the technology is its high success rate with two of the Company’s programs already achieving positive Phase 2a results. Additionally, while other AI-based approaches use methods based on data mining, structural similarity, or the target structure, SOMAI PRO uses molecular fields, allowing for an increased rate of success, with results achieved in the shortest possible time and considerably reducing the costs associated with drug discovery.
About SOM3355: SOM3355 is potentially the only safe VMAT2(-) not related to serious adverse events such as depression, suicide, parkinsonism, or neuroleptic syndrome. It has a potential maximum sales peak of €1.1 billion. The Company intends to initiate a Phase 2b later this year.
For more information about SOM Biotech, please contact:
Consilium Stratgeic Communications
Amber Fennell, Lindsey Neville, Lucy Featherstone
1 Bevantolol hydrochloride is currently commercialized as Calvan® in Japan, South Korea and China for the treatment of hypertension.