Clinical-stage biopharma company NeoImmuneTech (NIT) has dosed the first patient in its Phase I study analysing NT-I7 (efineptakin alfa) as a treatment in adult patients with mild Covid-19.
A long-acting human IL-7 fusion protein, NT-I7 is a T-cell amplifier in the clinical development stage for treating cancer and immunologic diseases.
The trial, sponsored by the company, is taking place in partnership with the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) and the University of Nebraska Medical Center (UNMC).
The multisite, double-blind, randomised, placebo-controlled, dose-escalating trial will assess the safety and efficacy of NT-I7 in adults with mild Covid-19.
Participants will randomly receive a single dose of NT-I7 with the standard of care (SOC) or placebo with SOC.
Research blood collection will occur at baseline, days three, seven, 14, 30, 60 and 90 after the study agent administration.
NeoImmuneTech executive vice-president and chief medical officer NgocDiep Le said: “NT-I7 has been shown to restore lymphocyte counts in cancer patients, which also appears to be essential for patients battling viral illnesses such as Covid-19 where low lymphocyte count is strongly associated with poor clinical outcomes.
“We believe that NT-I7 has the potential to reinvigorate patients’ immune systems to mount stronger responses to this aggressive infection.”
IL-7 can boost anti-viral T-cell responses, promote lymphocyte homing to the infection site, limit T-cell exhaustion and apoptosis as well as ameliorate immunosenescence by expanding the T-cell receptor repertoire.
NT-I7 is the only clinical-stage long-acting IL-7 with a well-tolerated safety profile in clinical trials and could increase lymphocyte counts in patients.
It is currently being studied in multiple clinical trials as a single agent, as well as in combination with other therapeutics in solid tumours and infectious diseases and as a vaccine adjuvant.