Unmet Need

Healthcare professionals frequently prescribe more than one therapeutic agent, each with a different mode of action, to address complex mechanisms of a disease. Multi-modal therapy has demonstrated improved outcomes across a range of conditions – from hypertension to chronic pain and oncology – and is recommended as the standard of care in many therapeutic areas. However, this approach creates a need for multiple prescriptions – increasing an out-of-pocket expenses – and often an arduous process, for both physicians and patients, of step-wise titration of individual drugs to achieve an optimal ratio resulting in optimal efficacy and tolerability level.

Improvements in the medicinal chemistry of proven drug combinations offer the potential for significant increases in efficacy while also reducing their side effects. Xgene’s proprietary linker technology, tailored to the recognized profiles of specific existing and newly discovered drugs, overcomes these limits and offers potentially better, safer, and more efficient therapy.

Acute and chronic pain conditions, the current clinical focus of Xgene, are widespread in the US and across the globe. Acute pain usually results from a medical procedure or injury and it can last for days or weeks frequently requiring medical intervention. Chronic pain, defined as daily pain for more than 3 months, has been characterized by impaired memory, cognition, and attention; sleep disturbances; reduced physical function; and work absenteeism. Wide-spread use of opioids to treat pain regardless of its origin has led to a declaration of a public health crisis in the US. XG005, a non-opioid proprietary conjugate in development as an oral and topical formulation, has a potential of greatly reducing if not eliminating the need to use opioids in many pain conditions.

Technology

New Chemical Entity
(New IP Protection)

Xgene’s proprietary linker technology creates oral and topical, multimodal drug conjugates. Studies of linked drug conjugates have shown improved safety profiles when compared with the two parent drugs given in combination. The linker technology may also offer improved efficacy properties. Xgene Pharmaceutical uses proprietary linker technology to connect complementary drug molecules. The new drug conjugates offer improved safety profiles and better clinical outcomes.

Values

Synchronized PK Profiles between Drug A and Drug B

A reduction in GI and Central Nervous System side effects (headache, dizziness, sleepiness, confusion, etc.)

Extend indication of parent drug products

Pipeline

PRODUCT CANDIDATE

DISCOVERY

PRECLINICIAL

PHASE 1

PHASE 2

PHASE 3

RIGHTS

ACUTE PAIN

XG005-02

Oral Tablet

Scheduled to enter 2 pivotal, US Phase III studies in acute pain in 1Q2021, this dual-acting drug conjugate of naproxen and pregablin has been engineered to reduce the gastrointestinal safety risks associated with naproxen and to improve clinical efficacy in the treatment of acute pain.

Global

CHRONIC PAIN

XG005-02

Oral Tablet

Scheduled to enter 2 pivotal, US Phase III studies in acute pain in 1Q2021, this dual-acting drug conjugate of naproxen and pregabalin has been engineered to reduce the gastrointestinal safety risks associated with Naproxen, minimize CNS side effects of pregabalin to achieve improved clinical outcomes in the treatment of chronic pain.

Global

CHRONIC PAIN

XG005-03

Topical Gel

A topical formulation of the dual action, naproxen-pregabalin drug conjugate for acute and chronic pain.

Global

NEUROPATHIC PAIN

XG004-03

Topical Gel

A steroisomer of XG005-03 with transdermal penetration properties in development for neurological disease.

Global

CLUSTER HEADACHE

XG043

Oral Tablet

Drug conjugate for cluster headache

Global

NEUROPATHIC PAIN

Novel Target

An ion channel modulator in development for neuropathic pain.

Global

Pipeline

ACUTE PAIN

XG005-02

Oral Tablet

Phase 2

 

Scheduled to enter 2 pivotal, US Phase III studies in acute pain in 1Q2021, this dual-acting drug conjugate of naproxen and pregablin has been engineered to reduce the gastrointestinal safety risks associated with naproxen and to improve clinical efficacy in the treatment of acute pain.

Global rights

CHRONIC PAIN

XG005-02

Oral Tablet

Phase 1

 

Scheduled to enter 2 pivotal, US Phase III studies in acute pain in 1Q2021, this dual-acting drug conjugate of naproxen and pregabalin has been engineered to reduce the gastrointestinal safety risks associated with Naproxen, minimize CNS side effects of pregabalin to achieve improved clinical outcomes in the treatment of chronic pain.

Global rights

CHRONIC PAIN

XG005-03

Topical Gel

Phase 1

 

A topical formulation of the dual action, naproxen-pregabalin drug conjugate for acute and chronic pain.

Global rights

NEUROPATHIC PAIN

XG004-03

Topical Gel

Preclinical

 

A steroisomer of XG005-03 with transdermal penetration properties in development for neurological disease.

Global rights

CLUSTER HEADACHE

XG043

Oral Tablet

Discovery

 

Drug conjugate for cluster headache

Global rights

NEUROPATHIC PAIN

Novel Target

Discovery

 

An ion channel modulator in development for neuropathic pain.

Global rights