NeuroScientific Biopharmaceuticals (ASX:NSB) share price jumped ~13% today to 35 cents after an update on its lead drug candidate EmtinB.

The company said it has executed on the successful completion of invitro genotoxicity and plasma protein binding studies for the EmtinB treatment.

The studies are a key step in developing the safety profile of EmtinB before first-in-human studies, which are due to start in the first half of 2022.

Managing Director and CEO Matt Liddelow says confirming the protein-binding profile of EmtinB in human plasma is also important for accurately guiding selection of the first-in-human dose.

EmtinB is being developed as a therapeutic treatment for a range of neurodegenerative conditions including multiple sclerosis (MS) and Alzheimer’s disease.

Auscann gets FDA boost

The medical cannabis company jumped by almost 20% in morning trade, after getting feedback from US heal regulators which gives AC8 clarity on an approval pathway for CPAT-01 — its cannabinoid-based veterinary medicine for the control of pain and inflammation in dogs with osteoarthritis.

The company said it’s received an official Memorandum of Conference (‘MOC’) from the U.S FDA-CVM, “supporting the development and regulatory pathway for CPAT-01”.

AC8 will now be able to establish pain management in dogs as the primary endpoint for it upcoming clinical trial, “with the potential to seek improvement in quality of life as a secondary endpoint”.

“AusCann has commenced the design phase for its Phase 2C clinical effectiveness trial to generate final pilot data to inform the design of the Company’s Phase 3 pivotal program to support a NADA for the approval of CPAT-01, as a world “first-in-class” U.S FDA registered veterinary medicine,” the company said.

Recce’s sepsis antibiotic on track

Recce Pharmaceuticals (ASX:RCE, FSE:R9Q) has reported positive safety data from the third cohort in its Phase I clinical trial of RECCE 327, a new class of antibiotic being developed  for sepsis.

The company reported phase 1 intravenous (IV) of RECCE 327 cohort three at 500mg, a tenfold increase on cohort one at 50mg) indicating a good safety and tolerability profile among 7 healthy males.

Recce CEO James Graham described the indications of R327 being safe and well tolerated at 500mg IV as a “wonderful milestone for the company”.

“These results are an excellent outcome for this clinically-invasive method of administration, with a few additional participants to strengthen a compelling safety profile and serves well for regulatory and synergistic program potential,” he said.

According to a report from the PEW Charitable Trusts, sepsis is the largest unmet medical need in human health, occurring when the body’s response to an infection damages its own tissues.

Antisense starts trial in new muscle disease

Antisense Therapeutics (ASX:ANP) share price is up ~3% after announcing dosing has started in an inflammatory muscle disease animal model, under its collaborative research deal with the Murdoch Children’s Research Institute (MCRI). 

The study is investigating the therapeutic potential of ATL1102 in a new muscle disease, where there are no effective treatments.

The company said all animals had successfully received their first does of the antisense CD94d drug or control the placebo. While ANP has filed patents to seek protection for the use of ATL1102 in this new indication, it has not name it stating that further “intellectual property protection could be generated through the successful conduct of the study program at the MCRI”.

However, the company advised it was a rare muscle disease that effects both children and adults with no effective marketed therapy and no disease modifying agents in advanced development.

Positive trial results for Chimeric

Clinical stage cell therapy company Chimeric Therapeutics (ASX:CHM) has reported encouraging initial data for the second dose cohort of the CLTX CAR T Phase 1 dose escalation study for patients with recurrent/progressive glioblastoma.

The study at US cancer research and treatment facility City of Hope showed positive initial safety as patients generally well tolerated the dual routes (intratumoral and intraventricular) of CLTX CAR T cell administration at the second dose amounts. The third dose cohort of the Phase 1 trial is now open to enrolment.

Demerger for Little Green Pharma

To pot stocks and the Gina Rhinehart Hancock Prospecting backed Little Green Pharma (ASX:LGP) will demerge its psychedelics business into separate unlisted entity Reset Mind Sciences Ltd.

LGP announced the demerger will be undertaken via pro-rata, in specie distribution of 100% or Reset securities to eligible LGP shareholders who afterwards will hold separate shares in both companies.

The LGP board is hoping the demerger will unlock strategic value of psychedelics business with increased research globally into its use for the treatment of various chronic mental health diseases.

Hancock prospecting invested $15 million into LGP last year and now holds ~10% of the company. The demerger is expected to be completed in the June quarter.

Creso’s Halucenex given psychedelics green light

Creso Pharma (ASX:CPH, OTC:COPHF,FRA:1X8) has announced its wholly-owned Canadian-based psychedelics subsidiary Halucenex Life Sciences has been given the green light to provide psychedelic compounds to researchers and patients under Canada’s Special Access Program (SAP).

Halucenex has been included on the list of companies authorised to provide psychedelics under the federal SAP program that enables healthcare professionals to apply for access to non-marketed medications that have not yet been approved for sale, Creso said.

The medications must have shown clinical evidence of safety and efficacy and are intended to treat patients with severe or life-threatening illness.

Regulatory changes to Health Canada’s SAP announced on January 5 reverse a 2013 decision to prohibit the use of psychedelics in the country.