Bsense Announces Positive Topline Proof-of-Concept Preclinical Data that Supports the Development in Additional Sensory Hyperexcitability Related Disorders

NESS ZIONA, Israel, Dec. 06, 2021 (GLOBE NEWSWIRE) -- Bsense Bio Therapeutics Ltd., a FutuRx portfolio biopharmaceutical company dedicated to developing novel therapeutics for treatment of sensory hyperexcitability disorders, today announced positive topline data in a comparative preclinical study of its leading compound BSEN627 with pregabalin in chronic pain. The data indicate that treatment with BSEN627 significantly alleviates chronic pain, potentially without any major related side effects, supporting its lead determination. Moreover, the data provide support in broadening its indication to additional sensory hyperexcitability related disorders.

The comparative study was designed to investigate anti-nociceptive efficacy and safety of BSEN627 vs pregabalin in the Spared Nerve Injury (SNI) pain rat model. Results from the study demonstrate that BSEN627 alleviated chronic pain supporting plans for further clinical development. Additional key findings from the study include:

• BSEN627 significantly alleviated the mechanical allodynia pain for up to 32 hours after a single administration

• BSEN627demonstrated comparable pain relief (mechanical) at significantly lower exposure levels compared to Pregabalin’s maximal efficacious human dose

• BSEN627 demonstrated a PK/PD profile, which supports the translation of in-vitro to in-vivo

• BSEN627 demonstrated a significant therapeutic window from target related safety concerns, while Pregabalin showed significant impairment

"Results from this study are very encouraging and demonstrate the potential for superior efficacy and safety in the treatment of chronic pain,” said Haim Belinson, Chief Scientific Officer of Bsense. “In addition, these results indicate that our novel mode of action (MOA) translates from in-vitro to in-vivo in a predictive manner. We look forward to continuing development of the Bsense dual ion-channel modulator technology in chronic pain, and exploring other potential indications such as tinnitus, pruritus and other pain indications in need of better standard of care.” Dr. Belinson continued, “We are very pleased that progress follows the work of Dr. David Julius, who has been recently awarded the Nobel Prize in Physiology or Medicine for his discovery of TRPV1 as the primer of the biology of senses, and optimistic for continued success along this development pathway.” Our current data supports our vision to continue development of the Bsense dual ion-channel modulator technology” added Belinson. “We envision these orally available, non-addictive treatments to be fitting for orphan and non-orphan sensory hyperexcitability related indications such as Tinnitus, Pruritus and Pain that are lacking efficacious and safe therapies” he concluded,

Dr. Kinneret Livant Savitzky, CEO of the FutuRx bio incubator added, “We are excited by the impressive efficacy and safety data from the dual ion-channel modulator technology presented by our portfolio company Bsense Bio Therapeutics. This clear demonstration of their ability to quell sensory neuron hyperexcitability offers a new hope for patients suffering from dire conditions such as neuropathic and chronic pain, tinnitus, chronic cough and pruritis. We look forward to further development of this promising technology.”

About Hyperexcitability Related Disorders

Sensory hyperexcitability translates to increase in sensory stimuli such as proprioception, vision, sound, and touch as unpleasantly heightened sensations. The pathophysiology could arise from nerve damage, inflammation, and metabolic diseases all of which may alter the normal function of sensory neurons. Sensory hyperexcitability is observed in many different neurological disorders, including Epilepsy, Anxiety, Autism, Pain, Tinnitus, Pruritus and many more. Sensory hyperexcitability related disorders impact millions of people worldwide. Moreover, these conditions have a dire effect on the quality of life of patients and present with a significant operational and economic burden on healthcare systems. The multitude of patients suffering from sensory hyperexcitability disorders emphasize the significant unmet medical need that ranges from complete lack of pharmacological treatment (i.e., Tinnitus, Prorigo nodularis) to conditions with multiple available pharmacological treatments but with unsatisfactory efficacy and at times also with significant side effects including drug abuse and addiction (i.e. pain).

In each case, the spatial and mechanistic emergence of sensory hyperexcitability may lead to different and varied medical manifestation. However, in all cases, the sensory neuronal system’s excessive activity is the hallmark of the disorder. Importantly, the anatomical positioning of the dorsal root ganglions (DRG) outside the blood-nerve barriers of the central nervous system, has made sensory neurons a prime target for altering incoming sensory signals. Thus, modulation of hyperexcitability at the level of DRG where Kv7.2/3 and TRPV1 are predominantly and mutually expressed presents a unique mechanism to provide significant relief and superior tolerability to sensory hyperexcitability disorders.

About FutuRx

FutuRx is a leading biotech incubator founded and supported by Johnson & Johnson Innovation – JJDC Inc., Takeda Ventures, OrbiMed Partners, LEAPS by Bayer and RMGP, in collaboration with the Israeli Innovation Authority. Its focus is on company creation and incubation of companies developing novel therapeutic targets and platforms. To date 25new companies have been incepted at FutuRx, each receiving ~$3M for a 3-year incubation period as well as interim management and hands on R&D and BD support. FutuRx has secured over $250M of follow-on funding for its portfolio companies and is currently actively raising funds for several more graduating portfolio companies. (https://www.futurx.co.il/)

About Bsense

Bsense Bio Therapeutics is developing dual cationic channel small molecule modulators for the treatment hyperexcitability related disorders. Bsense is pioneering a novel approach targeting multiple neuronal excitability related mechanisms using a single compound to achieve greater efficacy and safety.

Bsense Bio’s approach is based on the targeting of two cation channels, a ligand-gated and a voltage-gated potassium channel, respectively, TRPV1 and Kv7.2/3, which are co-localized on sensory neurons and are widely recognized as prominent players in controlling neuronal excitability.

Bsense Bio was established based on the initial discovery and identification of the dual ion-channel activity by Prof. Bernard Attali and Dr. Asher Peretz from Tel-Aviv University

Bsense Bio was founded in September 2018 at the FutuRx biotech incubator and is financed by Takeda Ventures Inc., OrbiMed Israel Partners, and Johnson & Johnson Innovation (JJDC), RMGP and the Israeli Innovation Authority (IIA).

Contact: Haim Belinson, +972-8-9553142