• Cynata gets clearance from FDA for Phase 2
  • Microba signs digital health deal with Midnight Health

Cynata gets FDA clearance

Regenerative medicine stock Cynata Therapetics (ASX:CYN) jumped almost 10% this morning, after getting the clearance from the US FDA for its Phase 2 clinical trial.

The FDA has cleared the Investigational New Drug (IND) application for Cynata’s Phase 2 clinical trial of its lead asset, CYP-001.

The Phase 2 trial’s objective is to study the efficacy of CYP-001 in patients with acute graft versus host disease, or aGvHD.

“This achievement represents a hugely important milestone in the development of CYP-001 and our Cymerus platform,” says Dr Kilian Kelly, Cynata’s chief operating officer.

Cynata had previously completed several positive interactions with the FDA, as well as securing an Orphan Drug Designation for CYP-001 in 2018.

However, the planned Phase 2 aGvHD trial will be its first clinical trial conducted in the US, the largest healthcare market worldwide.

The trial will seek to recruit approximately 60 patients with high risk aGvHD, at clinical centres in a number of countries, including the US and Australia.

Participants will be randomised to receive either CYP-001 or placebo, in addition to corticosteroids.

“We are delighted to have crossed this threshold and will continue to leverage the momentum in our negotiations with study centres with an expectation to commence a US trial in aGvHD by the end of the year,” commented CEO, Dr Ross Macdonald.


Cynata share price today:


Microba signs digital health deal

Microba Life Sciences (ASX:MAP) has signed a three-year deal with digital healthcare company Midnight Health, to deliver a personalised health service to the Australian consumer market.

Under the deal, Midnight Health will promote a world-first subscription-based service, known as Vidality, with its network of pharmacists to formulate personalised supplements for each customer based on their microbiome test results.

The service will leverage the recommendations from Microba’s Analysis Platform.

Midnight Health already has more than 13,000 subscribers across its existing brands, and the company says many of its customers are looking for gut health solutions.

The company is backed by ASX-lister nib Holdings Ltd (ASX:NHF).

Microba CEO, Dr Luke Reid said: “Consumers are seeking personalised, evidence-based solutions to support their gut health.”

“Together with Midnight Health, we are excited to bring the Vidality product to consumers, a truly personalised solution powered by our technology”.


Microba share price today: