• PYC Therapeutics to advance to Phase 2 clinical trial
  • Osteopore announced new CEO and non-executive director
  • Incannex has as engaged Fortrea to manage its Phase 2/3 clinical trial

 

PYC to advance to Phase 2 after toxicology tests

RNA drugs specialist PYC Therapeutics (ASX:PYC) announced that it has successfully completed the non-clinical toxicology testing required to progress to a Phase 2 clinical trial.

The company is advancing its investigational drug candidate VP-001 for the treatment of Retinitis Pigmentosa Type 11 (RP11) into a multiple dose study (Phase 2) in humans.

This clinical trial is expected to commence in about 12 months upon successful completion of the ongoing Phase 1 trial which is looking into single dose of VP-001 in patients with RP11.

Highlights from the non-clinical toxicology results today include: successful repeat dose Good Laboratory Practice (GLP) toxicology studies in two species; as well as successful in-vivo genotoxicity studies.

All studies were completed under GLP conditions, a standard required for submissions to regulators including the US FDA.

“These study results complement the existing data pack supporting the use of PYC’s RNA platform technology in the context of retinal diseases – an area of major unmet patient need,” said PYC’s CEO, Dr Rohan Hockings.

RP11 is a blinding eye disease that begins in childhood and ultimately leads to legal blindness in middle age. The disease affects around 1 in every 100,000 people, and is caused by insufficient expression of the PRPF31 gene in the retina.

There are currently no treatment options available for patients.

VP-001 meanwhile is a precision therapy that aims to restore the expression of the PRPF31 gene back to levels required for the normal function of the retina.

 

Osteopore name Michael Keenan as non-exec director

Bone specialist Osteopore (ASX:OSX) announced the strengthening of its leadership team with the appointment of the Hon. Michael Keenan as a non-executive director, and the promotion of Dr Lim Jing to the role of CEO, effective today.

Keenan served as an Australian Federal Member of Parliament from 2004 to 2019, and held senior ministry positions in the Abbott, Turnbull and Morrison governments between 2013 to 2019.

Dr Lim meanwhile joined Osteopore in 2014, and since 2018 has held the position of chief technology officer. In 2022, Dr Lim was appointed chief operating officer.

Dr Lim replaces Khoon Seng Goh as CEO as part of a planned succession that will see Goh move into the newly created role of global marketing director.

 

Incannex picks Fortrea to manage Phase 2/3 trial

Medicinal cannabis company Incannex Healthcare (ASX:IHL) has engaged Fortrea as the contract research organisation (CRO) to manage its Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA (bbstructive sleep apnoea).

Fortrea was previously engaged to conduct a 12-week operational feasibility study where the trial design was provided to potential investigators, along with a survey to gauge interest in conducting the study.

For this trial, Fortrea is expected to implement its technology solutions designed to increase drug development efficiency, reduce timelines, and improve compliance.

The extensive Phase 2/3 trial will be conducted across 45 sites, including many in the US.

There are no registered treatments currently available to people with OSA, representing a major economic opportunity to Incannex with IHL-42X.

 

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At Stockhead we tell it like it is. While Incannex Healthcare is a Stockhead advertiser, it did not sponsor this article. 

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