Health Check: New JV for Opyl; Dimerix inks another licensing deal

Opyl enters joint venture with X Firm to market its AI-powered TrialKey platform in Europe, Middle East, Africa and North America
Dimerix enters exclusive licence deal with Fuso Pharmaceutical Industries to develop and commercialise DMX-200 to treat FSGS in Japan
Opthea’s phase 1b trial results of sozinibercept combination therapy in diabetic macular edema (DME) published in a peer-reviewed journal

Biotech Opyl (ASX:OPL) has entered a joint venture (JV) with US and London-based X Firm to market and distribute its AI-powered TrialKey platform, on an exclusive basis in Europe, the Middle East, Africa and North America.

Opyl said the JV was in the process of raising $4.7-$7.8 million to fund its operations and marketing initiatives.

Under the deal Opyl will trade 19.99% of its shares for 19.99% of shares in a new JV company. The first US$1.25 million in revenue that the new entity makes Opyl will receive 20% and 40% of any revenue after this amount.

In addition to the JV, following the funding raise, Opyl will receive $1.5 million from X Firm paid over 12 months for a licensing fee.

Opyl entered a Memorandum of Understanding in mid-2024 with X Firm, which it said specialised in identifying market-ready IP with exceptional potential, and accelerating commercialisation by embedding expert teams, aligning operations, and enabling scalable commercialisation.

TrialKey’s AI-powered platform is designed to predict clinical trial outcomes, reduce failure risks, and improve drug development efficiency with its target client clinical research organisations (CROs).

“We see this technology as a true game-changer for improving performance in major pharmaceutical companies, contract research organisations, and major government and academic research laboratories,” said X Firm managing partner Whit Pepper.

“The ability to predict clinical trial outcomes with industry-leading precision has the potential to significantly
reduce costs, improve decision-making, and bring life-saving therapies to market faster.”

Opyl said it would retain its focus on the Asia-Pacific market while leveraging the JV to expand globally.

Dimerix inks lucrative licensing deal in Japan

Dimerix (ASX:DXB) is continuing its run of licensing deals into 2025 for its ACTION3 phase III drug candidate DMX-200 to treat focal segmental glomerulosclerosis (FSGS) kidney disease, this time inking a deal with Fuso Pharmaceutical Industries Pty Ltd in Japan.

Dimerix said Fuso will be responsible for all development costs, submission and maintenance of the regulatory dossier with the Japanese Pharmaceutical and Medical Device Agency (PMDA), as well as all sales and marketing activities in Japan.

In exchange for these rights Dimerix will receive a ¥300 million (~A$3.1m) within 40 days of executing the agreement, ¥400m (~A$4.1m) on initiation of the first clinical trial site, which is anticipated in Q1 CY25, plus potential development and commercialisation milestones of up to ¥9.8 billion (~A$100m).

In a further boost to its bank balance Dimerix is eligible to receive royalties of between 15-20% on net sales of DMX-200 if successfully commercialised.

Dimerix will continue to fund and execute the global ACTION3 phase III study for DMX-200 in FSGS patients outside of Japan.

It is the third licensing deal Dimerix has secured for DMX-200. The company has a deal with Advanz Pharma covering the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.

The company also has a licensing deal with Taiba in May 2024 incorporating several Middle Eastern countries including the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.

Dimerix said collectively the licensing deals provide up to ~AU$458 million in upfront payments and potential milestone payments, plus royalties on net sales. The company retains all rights to commercialise DMX-200 in all territories other than those covered by the Fuso, Advanz Pharma, and Taiba license agreements.

Opthea trial results published in peer-reviewed journal

Opthea (ASX:OPT) finished 2024 strongly with publication of its phase 1b trial of
sozinibercept (OPT-302) combination therapy in diabetic macular edema (DME) in the peer-reviewed journal Translational Vision Science & Technology (TVST), issued on December 19, 2024.

The clinical-stage biopharmaceutical company is developing novel therapies to treat highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD).

The publication, Phase 1b Dose Escalation Study of Sozinibercept Inhibition of Vascular
Endothelial Growth Factors C and D With Aflibercept for Diabetic Macular Edema, evaluated the outcomes in previously anti-VEGF-A monotherapy treated patients with persistent DME, a difficult-to-treat patient population.

The article was also included in the Anti-VEGF Special Journal Issue of TVST, the official journal of The Association for Research in Vision and Ophthalmology (ARVO).

“The DME trial results underpins sozinibercept’s potential as a novel, first-in-class VEGF-C/D ‘trap’ to elevate the standard of care in retinal diseases including DME, by preventing blood vessel growth and vascular leakage in the retina and delivering improved visual and anatomic outcomes when combined with standard-of-care anti-VEGF-A therapies,” said Opthea CEO Frederic Guerard.

The company’s COAST phase III results investigating OPT-302 in combination with aflibercept for the treatment of wet age-related macular degeneration (wet-AMD) are due early in Q2 CY25.

Results for its phase III ShORe trial investigating OPT-302 in combination with Ranibizumab in wet AMD are due in mid CY25.

“Whilst our immediate focus is to prepare for the anticipated sozinibercept Phase 3 topline data readout in wet AMD of COAST in early Q2 2025 and ShORe in mid-2025, we also plan to advance our clinical development program of sozinibercept in DME.”

At Stockhead we tell it like it is. While Dimerix is a Stockhead advertiser at the time of writing, it did not sponsor this article.