IMM files a pre-IND application with US FDA for IMM-529 targeting common pathogen clostridioides difficile
Ansell completes 100% acquisition of the assets of US giant Kimberly-Clark Corporation’s personal protective business
Actinogen XanaCIDD Phase 2a depression trial completes final patient visit with results expected in early August
Immuron (ASX:IMC) has filed a pre-IND (investigational new drug) application with the US Food and Drug Administration (FDA) for IMM-529, targeting common pathogen clostridioides difficile (C.diff).
IMM says the increased incidence of antibiotic resistant superbugs has amplified use of broad-spectrum antibiotics worldwide, with an unintended consequence disruption of the gastrointestinal microbiota, resulting in susceptibility to opportunistic pathogens, such as C.diff.
Essentially C.diff is a germ or bacterium that results in inflammation of the colon and can bring on diarrhoea and colitis.
“Paradoxically, treatment of Clostridioides difficile infection (CDI) also involves antibiotic use, and the heavy reliance on antibiotics to control C.diff does not allow for the gut flora to regenerate and predisposes the patient to relapsing CDI,” IMM says.
The company says C. diff is currently the most common pathogen in healthcare-associated infections and was deemed an urgent threat in the Center for Disease Control and Prevention’s report on antibiotic resistance threats in the US.
“CDI affects more than 400,000 people in the US on a yearly basis, contributing to over 30,000 deaths in the US alone annually,” IMM says.
“This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.”
To address this need, IMM is developing IMM-529 as an adjunctive therapy in combination with standard of care antibiotics for the prevention and/or treatment of recurrent CDI.
IMM-529 antibodies targeting C. diff may help to clear CDI infection and promote a quicker re-establishment of normal gut flora, providing an attractive oral preventative for recurrent CDI
Ansell completes US$640m Kimberley-Clark deal
Ansell (ASX:ANN), which operates in the personal protective equipment space (PPE) space, has announced it has completed the acquisition of 100% of the assets of US giant Kimberly-Clark Corporation’s personal protective business.
ANN told the market on April 8 that it was buying Kimberly-Clark’s Personal Protective Equipment business (KCPPE) for US$640m in cash.
KCPPE designs and markets differentiated hand, body and eye protection products under well-known Kimtech and KleenGuard brands to customers in global scientific, including life sciences, and industrial segments.
The purchase was partially funded through a $400m placement and $75m share purchase plan.
Announcing the acquisition CEO Neil Salmon told the market ANN had been looking at KCPPE as an attractive acquisition opportunity for some years.
“The Kimtech and KleenGuard brands we are acquiring and the experienced KCPPE business team behind them have strong reputations for quality and innovation built over many years of industry leadership,” he said at the time.
“These are similar qualities to Ansell, however, KCPPE has particular areas of strength across product portfolio, geographic position and sustainability differentiation that will meaningfully enhance Ansell’s overall position in the marketplace and customer differentiation.
“Our existing footprint, in addition to our global organisation and supply chain, creates the opportunity to generate significant synergy value from the acquisition while also enhancing our combined organic growth potential and we are excited about the benefits this will create for Ansell’s customers and shareholders.”
Final patient visit complete for Actinogen Phase 2a clinical trial
Actinogen Medical (ASX:ACW) says the final patient visit for its XanaCIDD Phase 2a clinical trial in patients with cognitive impairment in major depressive disorder (MDD) has been completed in the UK with top-line results forecast for the first half of August 2024.
ACW says randomised, double-blind, proof-of-concept placebo-controlled parallel group six-week trial is being conducted in 167 patients with persistent MDD and measurable cognitive impairment at baseline.
Xanamem at a dose of 10mg or placebo is being added to the existing anti-depressant therapy, or in patients with a previous
history of anti-depressant treatment, used as stand-alone treatment.
ACW says the primary endpoint is the computerised Cogstate “attention composite” test battery, measuring attention and working memory which was shown previously to be a sensitive measure of Xanamem benefit in the prior XanaMIA Part A and XanaHES trials.
The key secondary endpoint is the Montgomery-Asberg Depression Rating Scale (MADRS) which is a structured interview evaluating MDD symptoms and is a commonly used endpoint for major trials and regulatory approvals of anti-depressant medication.
Other secondary endpoints include an executive function cognitive composite, a memory function cognitive composite, proportions of responders and global clinical assessment scores.
“This robust, placebo-controlled trial of 167 people will inform us if Xanamem can improve cognition in these patients and assess any related effects on symptoms of depression itself,” ACW CMO Dr Dana Hilt says.
“Any positive effects on cognition in this trial would confirm prior trial findings of cognitive enhancement and support the likelihood of future success in the on-going 36-week phase 2b XanaMIA trial in patients with Alzheimer’s disease.”
Recce raises $8m via institutional placement, announces SPP
Recce Pharmaceuticals (ASX:RCE) has announced it has received firm commitments to raise $8m via a strongly supported placement to new and existing institutional investors at 45 cents/share to advance clinical trial.
RCE says positive impact fund, NorthStar Impact Fund has committed ~$2m to the placement, which will see 17.8 million new fully paid ordinary shares in the company.
The company says a share purchase plan (SPP) will be offered to eligible shareholders at the same offer price as the placement.
RCE is developing a new class of synthetic anti-infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens. The company’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives:
RCE says $7.5m of funds raised will be used for clinical trials including:
Phase 3 registrational topical clinical trial in Indonesia
Phase 2 UTI/Urosepsis clinical trials
Phase 2 Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
RCE says $1.5m will be spent on activities relating to its Investigational New Drug application to FDA with $1m for general working capital.
Following the cap raise RCE expects to have pro forma cash liquidity, before offer costs of ~$18.5m. The company also expects additional non-dilutive capital of $8.7m through US Department of Defence (~$3.3m) in Q3 CY24 and R&D Advance ($5.4m) in Q1 CY25 providing a total cash runway of $27.2m to fund the company through to FY26.
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